observlog_start
Item
begin
datetime
observlog_start (VAR_NAMES)
begin (LABEL)
datetime (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
5.0 (VARIABLE_ORDER)
Beginn (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_start (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Who hospitates?
integer
observlog_who (VAR_NAMES)
Who hospitates? (LABEL)
integer (DATA_TYPE)
1=Quality manager(s)|2=Examiner(s) (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
10.0 (VARIABLE_ORDER)
Wer hospitiert? (LABEL_DE)
1=Qualitätsverantwortliche(r)|2=Untersucher(in) (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_who (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Who hospitates?
CL Item
Quality manager(s) (1)
observlog_monitor
Item
Quality manager
integer
observlog_monitor (VAR_NAMES)
Quality manager (LABEL)
integer (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
15.0 (VARIABLE_ORDER)
Qualitätsverantwortliche(r) (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_monitor (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
2nd quality manager
integer
observlog_monitor_2nd_yn (VAR_NAMES)
2nd quality manager (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
20.0 (VARIABLE_ORDER)
2. Qualitätsverantwortliche(r)? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_monitor_2nd_yn (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
2nd quality manager
observlog_extern
Item
2nd quality manager?
string
observlog_extern (VAR_NAMES)
2nd quality manager? (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
30.0 (VARIABLE_ORDER)
Qualitätsverantwortliche(r) 2 (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_extern (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_monitor_examiner
Item
examiner/hospitant
integer
observlog_monitor_examiner (VAR_NAMES)
examiner/hospitant (LABEL)
integer (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
37.0 (VARIABLE_ORDER)
Untersucher(in)/Hospitant(in) (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_monitor_examiner (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_examiner
Item
examiner
integer
observlog_examiner (VAR_NAMES)
examiner (LABEL)
integer (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
38.0 (VARIABLE_ORDER)
Untersucher(in) (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_examiner (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
2nd examiner?
integer
observlog_examiner_2nd_yn (VAR_NAMES)
2nd examiner? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
39.0 (VARIABLE_ORDER)
2. Untersucher(in)? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_examiner_2nd_yn (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_examiner_2nd
Item
2nd examiner
integer
observlog_examiner_2nd (VAR_NAMES)
2nd examiner (LABEL)
integer (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
40.0 (VARIABLE_ORDER)
Untersucher(in) 2 (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_examiner_2nd (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Examination 1
integer
observlog_exam (VAR_NAMES)
Examination 1 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
51.0 (VARIABLE_ORDER)
Untersuchung 1 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
examination 2
integer
observlog_exam2 (VAR_NAMES)
examination 2 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
52.0 (VARIABLE_ORDER)
Untersuchung 2 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
examination 3
integer
observlog_exam3 (VAR_NAMES)
examination 3 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
53.0 (VARIABLE_ORDER)
Untersuchung 3 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam3 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
examination 4
integer
observlog_exam4 (VAR_NAMES)
examination 4 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
54.0 (VARIABLE_ORDER)
Untersuchung 4 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam4 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
Examination 5
integer
observlog_exam5 (VAR_NAMES)
Examination 5 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
55.0 (VARIABLE_ORDER)
Untersuchung 5 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam5 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
Examination 6
integer
observlog_exam6 (VAR_NAMES)
Examination 6 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
56.0 (VARIABLE_ORDER)
Untersuchung 6 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam6 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
Examination 7
integer
observlog_exam7 (VAR_NAMES)
Examination 7 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
57.0 (VARIABLE_ORDER)
Untersuchung 7 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam7 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
Examination 8
integer
observlog_exam8 (VAR_NAMES)
Examination 8 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
58.0 (VARIABLE_ORDER)
Untersuchung 8 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam8 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
Examination 9
integer
observlog_exam9 (VAR_NAMES)
Examination 9 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
59.0 (VARIABLE_ORDER)
Untersuchung 9 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam9 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
Examination 10
integer
observlog_exam10 (VAR_NAMES)
Examination 10 (LABEL)
integer (DATA_TYPE)
0=no further|1=Greeting, explanation, consent|2=previous illnesses|3=acceptance of stool sample|4=Urine sample|5=Questionnaire for self-answering|6=ECHO Heart - General|7=ECHO Heart - Aortic valve findings|8=ECHO Heart - Mitral Valve Findings|9=Echo liver|10=ECG|11=Blood sampling|12=Thyroid sonography|13=Thyroid nodule|14=Carotid sonography|15=Smears|16=Dental interview|17=DEX: strain|18=DEX: Function|19=DEX: Dental status|20=DEX: Conclusion|21=DEX: Chewing test examination|22=DEX: Chewing test scan|23=Somatometry|24=Body scanner|25=Blood pressure measurement|26=Handgrip test|27=Timed up & go|28=Aktimeter initialization|29=Final discussion, critique|30=Check-out and farewell|31=IMB: Agreements|32=IMB: Preparation|33=BIA: Procedure|34=VAE: Procedure|35=LIVERELA: Procedure|36=LUFU: Procedure|37=SPI: Expiration|38=IMB: Termination|39=STU: Stool input|40=STU: DNA Extraction|41=STU: Elastase|42=MRT: Procedure and general data|43=MRI: AdHoc reporting|44=Ad hoc reporting|45=Release of findings|46=Dispatch of laboratory findings|47=Drug registration|48=Medical interview (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
60.0 (VARIABLE_ORDER)
Untersuchung 10 (LABEL_DE)
0=keine weitere|1=Begrüßung, Aufklärung, Einverständnisse|2=Vorerkrankungen|3=Annahme Stuhlprobe|4=Urinabgabe|5=Fragebogen zum Selbstbeantworten|6=ECHO Herz - Allgemein|7=ECHO Herz - Aortenklappenbefund|8=ECHO Herz - Mitralklappenbefund|9=Echo Leber|10=EKG|11=Blutabnahme|12=Schilddrüsensonographie|13=Schilddrüsenknoten|14=Karotissonografie|15=Abstriche|16=Zahnmedizinisches Interview|17=DEX: Stamm|18=DEX: Funktion|19=DEX: Zahnstatus|20=DEX: Abschluss|21=DEX: Kautest Untersuchung|22=DEX: Kautest Scan|23=Somatometrie|24=Bodyscanner|25=Blutdruckmessung|26=Handgreiftest|27=Timed up & go|28=Aktimeter Initialisierung|29=Abschlussgespräch, Kritik|30=Check-out und Abschied|31=IMB: Einverständnisse|32=IMB: Vorbereitung|33=BIA: Ablauf|34=VAE: Ablauf|35=LIVERELA: Ablauf|36=LUFU: Ablauf|37=SPI: Ablauf|38=IMB: Abschluss|39=STU: Stuhleingang|40=STU: DNA Extraktion|41=STU: Elastase|42=MRT: Ablauf und allg. Daten|43=MRT: AdHoc-Befundung|44=Zufallsbefundung|45=Befundfreigabe|46=Versand Laborbefund|47=Medikamentenerfassung|48=Medizinisches Interview (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_exam10 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
Greeting, explanation, consent (1)
CL Item
previous illnesses (2)
CL Item
acceptance of stool sample (3)
CL Item
Questionnaire for self-answering (5)
CL Item
ECHO Heart - General (6)
CL Item
ECHO Heart - Aortic valve findings (7)
CL Item
ECHO Heart - Mitral Valve Findings (8)
CL Item
Blood sampling (11)
CL Item
Thyroid sonography (12)
CL Item
Thyroid nodule (13)
CL Item
Carotid sonography (14)
CL Item
Dental interview (16)
CL Item
DEX: Function (18)
CL Item
DEX: Dental status (19)
CL Item
DEX: Conclusion (20)
CL Item
DEX: Chewing test examination (21)
CL Item
DEX: Chewing test scan (22)
CL Item
Body scanner (24)
CL Item
Blood pressure measurement (25)
CL Item
Handgrip test (26)
CL Item
Timed up & go (27)
CL Item
Aktimeter initialization (28)
CL Item
Final discussion, critique (29)
CL Item
Check-out and farewell (30)
CL Item
IMB: Agreements (31)
CL Item
IMB: Preparation (32)
CL Item
BIA: Procedure (33)
CL Item
VAE: Procedure (34)
CL Item
LIVERELA: Procedure (35)
CL Item
LUFU: Procedure (36)
CL Item
SPI: Expiration (37)
CL Item
IMB: Termination (38)
CL Item
STU: Stool input (39)
CL Item
STU: DNA Extraction (40)
CL Item
STU: Elastase (41)
CL Item
MRT: Procedure and general data (42)
CL Item
MRI: AdHoc reporting (43)
CL Item
Ad hoc reporting (44)
CL Item
Release of findings (45)
CL Item
Dispatch of laboratory findings (46)
CL Item
Drug registration (47)
CL Item
Medical interview (48)
Item
abnormality?
integer
observlog_abnormality (VAR_NAMES)
abnormality? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
150.0 (VARIABLE_ORDER)
Auffälligkeit? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnormality (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Assignment of the abnormality
integer
observlog_abnormality_type1 (VAR_NAMES)
Assignment of the abnormality (LABEL)
integer (DATA_TYPE)
1=Examiner with ...|2=Subject with ...|3=State of examiner|4=State of proband|5=State of examination module|6=State of device|7=State of software|8=State of workplace/room|9=Condition biomaterials|10=Condition of consumables (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
155.0 (VARIABLE_ORDER)
Zuordnung der Auffälligkeit (LABEL_DE)
1=Untersucher mit ...|2=Proband mit ...|3=Zustand Untersucher|4=Zustand Proband|5=Zustand Untersuchungsmodul|6=Zustand Gerät|7=Zustand Software|8=Zustand Arbeitsplatz/Raum|9=Zustand Biomaterialien|10=Zustand Verbrauchsmaterialien (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnormality_type1 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Assignment of the abnormality
CL Item
Examiner with ... (1)
CL Item
Subject with ... (2)
CL Item
State of examiner (3)
CL Item
State of proband (4)
CL Item
State of examination module (5)
CL Item
State of device (6)
CL Item
State of software (7)
CL Item
State of workplace/room (8)
CL Item
Condition biomaterials (9)
CL Item
Condition of consumables (10)
Item
abnormality examiner with ...
integer
observlog_abnorm_examiner (VAR_NAMES)
abnormality examiner with ... (LABEL)
integer (DATA_TYPE)
1=Respondent|2=Device/examination material|3=Software|4=Workplace/Room|5=Biomaterials|6=Consumables|7=Examiner (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
157.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit ... (LABEL_DE)
1=Proband|2=Gerät/Untersuchungsmaterial|3=Software|4=Arbeitsplatz/Raum|5=Biomaterialien|6=Verbrauchsmaterialien|7=Untersucher (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_examiner (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with ...
CL Item
Device/examination material (2)
CL Item
Workplace/Room (4)
Item
abnormality examiner with proband
integer
observlog_ab_examiner_proband (VAR_NAMES)
abnormality examiner with proband (LABEL)
integer (DATA_TYPE)
1=social interaction with the proband|2=Questions to the proband|3=Action on the passive proband|4=Instruction to the proband|5=Explanation to the test person|6=Acquisition of data/measured values|7=Evaluation of the measurement (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
160.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Proband (LABEL_DE)
1=sozialer Umgang mit dem Probanden|2=Fragen an den Proband|3=Handlung am passiven Probanden|4=Handlungsanweisung an den Proband|5=Erläuterung an den Proband|6=Erfassung Daten/Messwerte|7=Beurteilung der Messung (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_proband (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with proband
CL Item
social interaction with the proband (1)
CL Item
Questions to the proband (2)
CL Item
Action on the passive proband (3)
CL Item
Instruction to the proband (4)
CL Item
Explanation to the test person (5)
CL Item
Acquisition of data/measured values (6)
CL Item
Evaluation of the measurement (7)
Item
abnormality examiner with device
integer
observlog_ab_examiner_device (VAR_NAMES)
abnormality examiner with device (LABEL)
integer (DATA_TYPE)
8=Availability|1=Operation|2=Reading or entering the measured value|3=Evaluation Measurement|4=Cleaning, care, maintenance|5=Calibration|6=Storage|7=Documentation (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
162.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Gerät (LABEL_DE)
8=Verfügbarkeit|1=Bedienung|2=Ablesen oder Eintragen des Messwertes|3=Beurteilung Messung|4=Reinigung, Pflege, Wartung|5=Kalibrierung|6=Lagerung|7=Dokumentation (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_device (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with device
CL Item
Reading or entering the measured value (2)
CL Item
Evaluation Measurement (3)
CL Item
Cleaning, care, maintenance (4)
CL Item
Documentation (7)
Item
abnormality examiner with software
integer
observlog_ab_examiner_webform (VAR_NAMES)
abnormality examiner with software (LABEL)
integer (DATA_TYPE)
1=Operation|2=Reading or entering the measured value|3=Evaluation measurement/image/data|4=Documentation (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
163.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Software (LABEL_DE)
1=Bedienung|2=Ablesen oder Eintragen des Messwertes|3=Beurteilung Messung/Bild/Daten|4=Dokumentation (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_webform (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with software
CL Item
Reading or entering the measured value (2)
CL Item
Evaluation measurement/image/data (3)
CL Item
Documentation (4)
Item
abnormality examiner with room
integer
observlog_ab_examiner_room (VAR_NAMES)
abnormality examiner with room (LABEL)
integer (DATA_TYPE)
1=Regulation of room values|2=Adjustment/adjustment of inventory|3=Order and cleanliness (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
164.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Raum (LABEL_DE)
1=Regulation der Raumwerte|2=Anpassungen/Einstellung am Inventar|3=Ordnung und Sauberkeit (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_room (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with room
CL Item
Regulation of room values (1)
CL Item
Adjustment/adjustment of inventory (2)
CL Item
Order and cleanliness (3)
Item
abnormality examiner with biomaterial
integer
observlog_ab_examiner_biomat (VAR_NAMES)
abnormality examiner with biomaterial (LABEL)
integer (DATA_TYPE)
1=Availability|2=Preparation/pre-analysis on site|3=Transfer/transport|4=Storage (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
165.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Biomaterial (LABEL_DE)
1=Verfügbarkeit|2=Aufbereitung/Präanalytik vor Ort|3=Übergabe/Transport|4=Lagerung (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_biomat (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with biomaterial
CL Item
Preparation/pre-analysis on site (2)
CL Item
Transfer/transport (3)
Item
abnormality examiner with consumables
integer
observlog_ab_examiner_consum (VAR_NAMES)
abnormality examiner with consumables (LABEL)
integer (DATA_TYPE)
1=Availability|2=Working with consumables|3=Disposal|4=Storage (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
166.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Verbrauchsmaterial (LABEL_DE)
1=Verfügbarkeit|2=Arbeiten mit Verbrauchsmaterialien|3=Entsorgung|4=Lagerung (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_consum (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with consumables
CL Item
Working with consumables (2)
Item
abnormality examiner with examiner
integer
observlog_ab_examiner_examin (VAR_NAMES)
abnormality examiner with examiner (LABEL)
integer (DATA_TYPE)
1=social interaction|2=Differences (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
167.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher mit Untersucher (LABEL_DE)
1=sozialer Umgang|2=Unterschiede (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_examin (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner with examiner
CL Item
social interaction (1)
Item
abnormality "condition examiner"
integer
observlog_ab_examiner_status (VAR_NAMES)
abnormality "condition examiner" (LABEL)
integer (DATA_TYPE)
1=availability|2=external/physical condition|3=mental state (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
168.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Untersucher" (LABEL_DE)
1=Verfügbarkeit|2=äußerer/körperlicher Zustand|3=psychischer Zustand (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_examiner_status (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "condition examiner"
CL Item
external/physical condition (2)
Item
abnormality proband with ...
integer
observlog_ab_proband (VAR_NAMES)
abnormality proband with ... (LABEL)
integer (DATA_TYPE)
1=Examiner|2=Device/examination material|3=Software|4=Room (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
169.0 (VARIABLE_ORDER)
Auffälligkeit Proband mit ... (LABEL_DE)
1=Untersucher|2=Gerät/Untersuchungsmaterial|3=Software|4=Raum (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_proband (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality proband with ...
CL Item
Device/examination material (2)
Item
abnormality proband with examiner
integer
observlog_abnorm_proband (VAR_NAMES)
abnormality proband with examiner (LABEL)
integer (DATA_TYPE)
1=social handling|2=Answer|3=Question|4=Action according to instructions (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
170.0 (VARIABLE_ORDER)
Auffälligkeit Proband mit Untersucher (LABEL_DE)
1=sozialer Umgang|2=Antwort|3=Frage|4=Handlung nach Anweisung (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_proband (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality proband with examiner
CL Item
social handling (1)
CL Item
Action according to instructions (4)
Item
abnormality proband with device
integer
observlog_ab_proband_device (VAR_NAMES)
abnormality proband with device (LABEL)
integer (DATA_TYPE)
1=Operation|2=measured value/answer (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
172.0 (VARIABLE_ORDER)
Auffälligkeit Proband mit Gerät (LABEL_DE)
1=Bedienung|2=Messwert/Antwort (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_proband_device (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality proband with device
CL Item
measured value/answer (2)
Item
abnormality proband with software
integer
observlog_ab_proband_webform (VAR_NAMES)
abnormality proband with software (LABEL)
integer (DATA_TYPE)
1=Operation|2=Measured value/response (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
174.0 (VARIABLE_ORDER)
Auffälligkeit Proband mit Software (LABEL_DE)
1=Bedienung|2=Messwert/Antwort (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_proband_webform (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality proband with software
CL Item
Measured value/response (2)
Item
abnormality proband with room
integer
observlog_ab_proband_room (VAR_NAMES)
abnormality proband with room (LABEL)
integer (DATA_TYPE)
1=Accessibility/Accessibility (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
176.0 (VARIABLE_ORDER)
Auffälligkeit Proband mit Raum (LABEL_DE)
1=Erreichbarkeit/Begehbarkeit (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_proband_room (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality proband with room
CL Item
Accessibility/Accessibility (1)
Item
abnormality "condition proband"
integer
observlog_ab_proband_status (VAR_NAMES)
abnormality "condition proband" (LABEL)
integer (DATA_TYPE)
1=availability|2=external/physical state|3=mental state|4=physical/physical state change (reaction)|5=mental state change (reaction) (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
183.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Proband" (LABEL_DE)
1=Verfügbarkeit|2=äußerer/körperlicher Zustand|3=psychischer Zustand|4=körperliche/physische Zustandsänderung (Reaktion)|5=psychische Zustandsänderung (Reaktion) (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_ab_proband_status (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "condition proband"
CL Item
external/physical state (2)
CL Item
physical/physical state change (reaction) (4)
CL Item
mental state change (reaction) (5)
Item
abnormality "condition of examination module"
integer
observlog_abnorm_module (VAR_NAMES)
abnormality "condition of examination module" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Feasibility|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
185.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Untersuchungsmodul" (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Machbarkeit|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_module (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "condition of examination module"
CL Item
Functionality (2)
Item
abnormality "condition device"
integer
observlog_abnorm_device (VAR_NAMES)
abnormality "condition device" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Ergonomics/Operation|4=Settings|5=Calibration|6=Cleaning/Care/Maintenance|7=Storage|8=Documentation (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
187.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Gerät" (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Ergonomie/Bedienung|4=Einstellungen|5=Kalibrierung|6=Reinigung/Pflege/Wartung|7=Lagerung|8=Dokumentation (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_device (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "condition device"
CL Item
Functionality (2)
CL Item
Ergonomics/Operation (3)
CL Item
Cleaning/Care/Maintenance (6)
CL Item
Documentation (8)
Item
abnormality "Condition Software"
integer
observlog_abnorm_webform (VAR_NAMES)
abnormality "Condition Software" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Operation/ergonomics|4=Updates/up-to-dateness|5=Documentation (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
189.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Software" (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Bedienung/Ergonomie|4=Updates/Aktualität|5=Dokumentation (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_webform (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition Software"
CL Item
Functionality (2)
CL Item
Operation/ergonomics (3)
CL Item
Updates/up-to-dateness (4)
CL Item
Documentation (5)
Item
abnormality "Condition of workplace/room"
integer
observlog_abnorm_room (VAR_NAMES)
abnormality "Condition of workplace/room" (LABEL)
integer (DATA_TYPE)
1=accessibility/availability|2=availability|3=functionality|4=tidiness|5=Ergonomics|6=Atmosphere|7=Room values (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
191.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Arbeitsplatz/Raum" (LABEL_DE)
1=Erreichbarkeit/Begehbarkeit|2=Verfügbarkeit|3=Funktionalität|4=Ordentlichkeit|5=Ergonomie|6=Atmosphäre|7=Raumwerte (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_room (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition of workplace/room"
CL Item
accessibility/availability (1)
CL Item
functionality (3)
Item
abnormality "Condition of biomaterials"
integer
observlog_abnorm_others (VAR_NAMES)
abnormality "Condition of biomaterials" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=On-site processing/pre-analytics|4=Transfer/Transport|5=Storage (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
193.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Biomaterialien" (LABEL_DE)
1=Verfügbarkeit|2=Funktionalität|3=Aufbereitung/Präanalytik vor Ort|4=Übergabe/Transport|5=Lagerung (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_others (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition of biomaterials"
CL Item
Functionality (2)
CL Item
On-site processing/pre-analytics (3)
CL Item
Transfer/Transport (4)
Item
abnormality "Condition consumables"
integer
observlog_abnorm_consumable (VAR_NAMES)
abnormality "Condition consumables" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Disposal|4=Storage (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
195.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Verbrauchsmaterialien" (LABEL_DE)
1=Verfügbarkeit|2=Funktionalität|3=Entsorgung|4=Lagerung (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_consumable (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition consumables"
CL Item
Functionality (2)
Item
Evaluation of the abnormality
integer
observlog_abnorm_rating (VAR_NAMES)
Evaluation of the abnormality (LABEL)
integer (DATA_TYPE)
1=positive|5=neutral - note|2=status unclear|3=quality relevant|4=significantly relevant to quality (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
197.0 (VARIABLE_ORDER)
Wertung der Auffälligkeit (LABEL_DE)
1=positiv|5=neutral - Hinweis|2=Status unklar|3=qualitätsrelevant|4=erheblich qualitätsrelevant (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_rating (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Evaluation of the abnormality
CL Item
neutral - note (5)
CL Item
status unclear (2)
CL Item
quality relevant (3)
CL Item
significantly relevant to quality (4)
observlog_abnormality_note
Item
Description of the abnormality
string
observlog_abnormality_note (VAR_NAMES)
Description of the abnormality (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
199.0 (VARIABLE_ORDER)
Beschreibung der Auffälligkeit (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnormality_note (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Is it possible and necessary to determine the cause?
integer
observlog_cause_need (VAR_NAMES)
Is it possible and necessary to determine the cause? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
200.0 (VARIABLE_ORDER)
Ist es möglich und nötig die Ursache zu ermitteln? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_need (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Is it possible and necessary to determine the cause?
Item
Is the cause known?
integer
observlog_cause_known (VAR_NAMES)
Is the cause known? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
201.0 (VARIABLE_ORDER)
Ist die Ursache bekannt? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_known (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Is the cause known?
Item
Assignment of the cause
integer
observlog_cause_type (VAR_NAMES)
Assignment of the cause (LABEL)
integer (DATA_TYPE)
1=Investigator|2=Respondent|3=Examination module|4=State of device|5=State of software|6=State of workplace/room|7=Condition biomaterials|8=Condition of consumables (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
202.0 (VARIABLE_ORDER)
Zuordnung der Ursache (LABEL_DE)
1=Untersucher|2=Proband|3=Untersuchungsmodul|4=Zustand Gerät|5=Zustand Software|6=Zustand Arbeitsplatz/Raum|7=Zustand Biomaterialien|8=Zustand Verbrauchsmaterialien (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_type (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Assignment of the cause
CL Item
Examination module (3)
CL Item
State of device (4)
CL Item
State of software (5)
CL Item
State of workplace/room (6)
CL Item
Condition biomaterials (7)
CL Item
Condition of consumables (8)
Item
cause Examiner
integer
observlog_cause_examiner (VAR_NAMES)
cause Examiner (LABEL)
integer (DATA_TYPE)
1=social interaction with the test person|2=Questions to the proband|3=Action on the passive proband|4=Action instruction to the proband|5=Explanation to the test person|6=Preparation and post-processing of the workplace|7=Device/hardware operation|8=Cleaning, maintenance, calibration|9=Software operation|10=Transfer of measured values|11=Evaluation of measurement/image/data|16=Working with biomaterials|17=working with consumables|15=documentation|12=external/physical condition|13=mental condition|14=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
204.0 (VARIABLE_ORDER)
Ursache Untersucher (LABEL_DE)
1=sozialer Umgang mit dem Probanden|2=Fragen an den Probanden|3=Handlung am passiven Proband|4=Handlungsanweisung an den Proband|5=Erläuterung an den Proband|6=Vor- und Nachbereitung Arbeitsplatz|7=Geräte-/Hardwarebedienung|8=Reinigung, Wartung, Kalibrierung|9=Softwarebedienung|10=Übertragung Messwerte|11=Beurteilung der Messung/Bild/Daten|16=Arbeiten mit Biomaterialien|17=Arbeiten mit Verbrauchsmaterialien|15=Dokumentation|12=äußerer/physischer Zustand|13=psychischer Zustand|14=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_examiner (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
social interaction with the test person (1)
CL Item
Questions to the proband (2)
CL Item
Action on the passive proband (3)
CL Item
Action instruction to the proband (4)
CL Item
Explanation to the test person (5)
CL Item
Preparation and post-processing of the workplace (6)
CL Item
Device/hardware operation (7)
CL Item
Cleaning, maintenance, calibration (8)
CL Item
Software operation (9)
CL Item
Transfer of measured values (10)
CL Item
Evaluation of measurement/image/data (11)
CL Item
Working with biomaterials (16)
CL Item
working with consumables (17)
CL Item
documentation (15)
CL Item
external/physical condition (12)
CL Item
mental condition (13)
Item
Cause proband
integer
observlog_cause_proband (VAR_NAMES)
Cause proband (LABEL)
integer (DATA_TYPE)
9=social interaction|1=independent action|2=Answer|3=Question|10=action according to instructions|4=Software operation|5=physical condition|6=mental state|7=physical/physical reaction|8=mental reaction|11=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
205.0 (VARIABLE_ORDER)
Ursache Proband (LABEL_DE)
9=sozialer Umgang|1=eigenständige Handlung|2=Antwort|3=Frage|10=Handlung nach Anweisungen|4=Softwarebedienung|5=körperlicher/physischer Zustand|6=psychischer Zustand|7=körperliche/physische Reaktion|8=psychische Reaktion|11=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_proband (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
CL Item
social interaction (9)
CL Item
independent action (1)
CL Item
action according to instructions (10)
CL Item
Software operation (4)
CL Item
physical condition (5)
CL Item
physical/physical reaction (7)
CL Item
mental reaction (8)
Item
Cause of examination module
integer
observlog_cause_module (VAR_NAMES)
Cause of examination module (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Feasibility|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
206.0 (VARIABLE_ORDER)
Ursache Untersuchungsmodul (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Machbarkeit|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_module (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Cause of examination module
CL Item
Functionality (2)
Item
Cause "Condition of device"
integer
observlog_cause_device (VAR_NAMES)
Cause "Condition of device" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Operation/ergonomics|4=Settings|5=Calibration|6=Cleaning/care/maintenance|7=Storage|8=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
207.0 (VARIABLE_ORDER)
Ursache "Zustand Gerät" (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Bedienung/Ergonomie|4=Einstellungen|5=Kalibrierung|6=Reinigung/Pflege/Wartung|7=Lagerung|8=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_device (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Cause "Condition of device"
CL Item
Functionality (2)
CL Item
Operation/ergonomics (3)
CL Item
Cleaning/care/maintenance (6)
Item
Cause "Software condition"
integer
observlog_cause_webform (VAR_NAMES)
Cause "Software condition" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Operation/ergonomics|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
208.0 (VARIABLE_ORDER)
Ursache "Zustand Software" (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Bedienung/Ergonomie|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_webform (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Cause "Software condition"
CL Item
Functionality (2)
CL Item
Operation/ergonomics (3)
Item
Cause "Condition of workplace/room"
integer
observlog_cause_room (VAR_NAMES)
Cause "Condition of workplace/room" (LABEL)
integer (DATA_TYPE)
1=Accessibility/Accessibility|2=Functionality|3=Neatness|4=Ergonomics|5=Atmosphere (feel-good)|6=Room values (temp., volume, brightness, humidity)|7=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
209.0 (VARIABLE_ORDER)
Ursache "Zustand Arbeitsplatz/Raum" (LABEL_DE)
1=Erreichbarkeit/Begehbarkeit|2=Funktionalität|3=Ordentlichkeit|4=Ergonomie|5=Atmosphäre (Wohlfühl-)|6=Raumwerte (Temp., Lautstärke, Helligkeit, Luftfeuchte)|7=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_room (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Cause "Condition of workplace/room"
CL Item
Accessibility/Accessibility (1)
CL Item
Functionality (2)
CL Item
Atmosphere (feel-good) (5)
CL Item
Room values (temp., volume, brightness, humidity) (6)
Item
Cause "Condition of biomaterials"
integer
observlog_cause_biomaterial (VAR_NAMES)
Cause "Condition of biomaterials" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Storage|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
210.0 (VARIABLE_ORDER)
Ursache "Zustand Biomaterialien" (LABEL_DE)
1=Verfügbarkeit|2=Funktionalität|3=Lagerung|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_biomaterial (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Cause "Condition of biomaterials"
CL Item
Functionality (2)
Item
Cause "Condition of consumables"
integer
observlog_cause_consumable (VAR_NAMES)
Cause "Condition of consumables" (LABEL)
integer (DATA_TYPE)
1=Functionality|2=Availability|3=Storage|4=Disposal|5=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
211.0 (VARIABLE_ORDER)
Ursache "Zustand Verbrauchsmaterialien" (LABEL_DE)
1=Funktionalität|2=Verfügbarkeit|3=Lagerung|4=Entsorgung|5=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_consumable (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Cause "Condition of consumables"
CL Item
Functionality (1)
observlog_cause_report
Item
Description of cause
string
observlog_cause_report (VAR_NAMES)
Description of cause (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
212.0 (VARIABLE_ORDER)
Beschreibung der Ursache (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_cause_report (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Measures planned?
integer
observlog_measures_yn (VAR_NAMES)
Measures planned? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
215.0 (VARIABLE_ORDER)
Maßnahmen geplant? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_yn (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Measures planned?
Item
Planned measures
integer
observlog_measures (VAR_NAMES)
Planned measures (LABEL)
integer (DATA_TYPE)
2=Method change/SOP change|1=SOP - Supplement|16=Web form - troubleshooting|4=Web form - change|3=Web form - new function/variable|5=Site Visit - investigator among themselves|6=Site visit - quality manager|7=Site Visit - QV external|8=Training|9=Training - with ARCUS|10=Device exchange/rotation|11=Double examination|12=Plausibility check|14=Hospitation with an experienced examiner|15=Hospitation in the clinic|13=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
216.0 (VARIABLE_ORDER)
geplante Maßnahmen (LABEL_DE)
2=Methodenveränderung/SOP-Änderung|1=SOP - Ergänzung|16=Webformular - Fehlerbehebung|4=Webformular - Änderung|3=Webformular - neue Funktion/Variable|5=Site Visit - Untersucher untereinander|6=Site Visit - Qualitätsverantwortlicher|7=Site Visit - QV extern|8=Schulung|9=Training - mit ARCUS|10=Gerätetausch/-rotation|11=Doppeluntersuchung|12=Plausibilitätsprüfung|14=Hospitation bei einem erfahrenen Untersucher|15=Hospitation in der Klinik|13=Sonstige (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Planned measures
CL Item
Method change/SOP change (2)
CL Item
SOP - Supplement (1)
CL Item
Web form - troubleshooting (16)
CL Item
Web form - change (4)
CL Item
Web form - new function/variable (3)
CL Item
Site Visit - investigator among themselves (5)
CL Item
Site visit - quality manager (6)
CL Item
Site Visit - QV external (7)
CL Item
Training - with ARCUS (9)
CL Item
Device exchange/rotation (10)
CL Item
Double examination (11)
CL Item
Plausibility check (12)
CL Item
Hospitation with an experienced examiner (14)
CL Item
Hospitation in the clinic (15)
observlog_measures_report
Item
Description of the measures
string
observlog_measures_report (VAR_NAMES)
Description of the measures (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
218.0 (VARIABLE_ORDER)
Beschreibung der Maßnahmen (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_report (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_measures_implement
Item
Method change since:
datetime
observlog_measures_implement (VAR_NAMES)
Method change since: (LABEL)
datetime (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
219.0 (VARIABLE_ORDER)
Methodenveränderung seit: (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_implement (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Further measures planned?
integer
observlog_measures_yn_other (VAR_NAMES)
Further measures planned? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
230.0 (VARIABLE_ORDER)
Weitere Maßnahme geplant? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_yn_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Further measures planned?
Item
planned measure
integer
observlog_measures_other (VAR_NAMES)
planned measure (LABEL)
integer (DATA_TYPE)
2=Method change/SOP change|1=SOP - Supplement|16=Web form - troubleshooting|4=Web form - change|3=Web form - new function/variable|5=Site Visit - investigator among themselves|6=Site visit - quality manager|7=Site Visit - QV external|8=Training|9=Training - with ARCUS|10=Device exchange/rotation|11=Double examination|12=Plausibility check|14=Hospitation with an experienced examiner|15=Hospitation in the clinic|13=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
232.0 (VARIABLE_ORDER)
geplante Maßnahme (LABEL_DE)
2=Methodenveränderung/SOP-Änderung|1=SOP - Ergänzung|16=Webformular - Fehlerbehebung|4=Webformular - Änderung|3=Webformular - neue Funktion/Variable|5=Site Visit - Untersucher untereinander|6=Site Visit - Qualitätsverantwortlicher|7=Site Visit - QV extern|8=Schulung|9=Training - mit ARCUS|10=Gerätetausch/-rotation|11=Doppeluntersuchung|12=Plausibilitätsprüfung|14=Hospitation bei einem erfahrenen Untersucher|15=Hospitation in der Klinik|13=Sonstige (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
planned measure
CL Item
Method change/SOP change (2)
CL Item
SOP - Supplement (1)
CL Item
Web form - troubleshooting (16)
CL Item
Web form - change (4)
CL Item
Web form - new function/variable (3)
CL Item
Site Visit - investigator among themselves (5)
CL Item
Site visit - quality manager (6)
CL Item
Site Visit - QV external (7)
CL Item
Training - with ARCUS (9)
CL Item
Device exchange/rotation (10)
CL Item
Double examination (11)
CL Item
Plausibility check (12)
CL Item
Hospitation with an experienced examiner (14)
CL Item
Hospitation in the clinic (15)
observlog_measures_rep_other
Item
Description of measures
string
observlog_measures_rep_other (VAR_NAMES)
Description of measures (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
234.0 (VARIABLE_ORDER)
Beschreibung der Maßnahmen (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_rep_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_measures_imp_other
Item
Method change since:
datetime
observlog_measures_imp_other (VAR_NAMES)
Method change since: (LABEL)
datetime (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
236.0 (VARIABLE_ORDER)
Methodenveränderung seit: (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_imp_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Other abnormality?
integer
observlog_abnormality2 (VAR_NAMES)
Other abnormality? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
332.0 (VARIABLE_ORDER)
Weitere Auffälligkeit? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnormality2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Other abnormality?
Item
Assignment of the abnormality
integer
observlog_abnormality_type2 (VAR_NAMES)
Assignment of the abnormality (LABEL)
integer (DATA_TYPE)
1=Investigator|2=Respondent|3=Examination module|4=State of device|5=State of software|6=State of workplace/room|7=Condition biomaterials|8=Condition of consumables (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
334.0 (VARIABLE_ORDER)
Zuordnung der Auffälligkeit (LABEL_DE)
1=Untersucher|2=Proband|3=Untersuchungsmodul|4=Zustand Gerät|5=Zustand Software|6=Zustand Arbeitsplatz/Raum|7=Zustand Biomaterialien|8=Zustand Verbrauchsmaterialien (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnormality_type2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Assignment of the abnormality
CL Item
Examination module (3)
CL Item
State of device (4)
CL Item
State of software (5)
CL Item
State of workplace/room (6)
CL Item
Condition biomaterials (7)
CL Item
Condition of consumables (8)
Item
abnormality examiner
integer
observlog_abnorm_examiner2 (VAR_NAMES)
abnormality examiner (LABEL)
integer (DATA_TYPE)
1=social interaction with the test person|2=Questions to the proband|3=Action on the passive proband|4=Action instruction to the proband|5=Explanation to the test person|6=Preparation and post-processing of the workplace|7=Device/hardware operation|8=Cleaning, maintenance, calibration|9=Software operation|10=Transfer of measured values|11=Evaluation of measurement/image/data|16=Working with biomaterials|17=working with consumables|15=documentation|12=external/physical condition|13=mental condition|14=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
336.0 (VARIABLE_ORDER)
Auffälligkeit Untersucher (LABEL_DE)
1=sozialer Umgang mit dem Probanden|2=Fragen an den Probanden|3=Handlung am passiven Proband|4=Handlungsanweisung an den Proband|5=Erläuterung an den Proband|6=Vor- und Nachbereitung Arbeitsplatz|7=Geräte-/Hardwarebedienung|8=Reinigung, Wartung, Kalibrierung|9=Softwarebedienung|10=Übertragung Messwerte|11=Beurteilung der Messung/Bild/Daten|16=Arbeiten mit Biomaterialien|17=Arbeiten mit Verbrauchsmaterialien|15=Dokumentation|12=äußerer/physischer Zustand|13=psychischer Zustand|14=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_examiner2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examiner
CL Item
social interaction with the test person (1)
CL Item
Questions to the proband (2)
CL Item
Action on the passive proband (3)
CL Item
Action instruction to the proband (4)
CL Item
Explanation to the test person (5)
CL Item
Preparation and post-processing of the workplace (6)
CL Item
Device/hardware operation (7)
CL Item
Cleaning, maintenance, calibration (8)
CL Item
Software operation (9)
CL Item
Transfer of measured values (10)
CL Item
Evaluation of measurement/image/data (11)
CL Item
Working with biomaterials (16)
CL Item
working with consumables (17)
CL Item
documentation (15)
CL Item
external/physical condition (12)
CL Item
mental condition (13)
Item
abnormality proband
integer
observlog_abnorm_proband2 (VAR_NAMES)
abnormality proband (LABEL)
integer (DATA_TYPE)
9=social interaction|1=independent action|2=Answer|3=Question|10=action according to instructions|4=Software operation|5=physical condition|6=mental state|7=physical/physical reaction|8=mental reaction|11=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
338.0 (VARIABLE_ORDER)
Auffälligkeit Proband (LABEL_DE)
9=sozialer Umgang|1=eigenständige Handlung|2=Antwort|3=Frage|10=Handlung nach Anweisungen|4=Softwarebedienung|5=körperlicher/physischer Zustand|6=psychischer Zustand|7=körperliche/physische Reaktion|8=psychische Reaktion|11=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_proband2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality proband
CL Item
social interaction (9)
CL Item
independent action (1)
CL Item
action according to instructions (10)
CL Item
Software operation (4)
CL Item
physical condition (5)
CL Item
physical/physical reaction (7)
CL Item
mental reaction (8)
Item
abnormality examination module
integer
observlog_abnorm_module2 (VAR_NAMES)
abnormality examination module (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Feasibility|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
339.0 (VARIABLE_ORDER)
Auffälligkeit Untersuchungsmodul (LABEL_DE)
1=Verfügbarkeit|2=Funktionsfähigkeit|3=Machbarkeit|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_module2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality examination module
CL Item
Functionality (2)
Item
abnormality "condition device"
integer
observlog_abnorm_device2 (VAR_NAMES)
abnormality "condition device" (LABEL)
integer (DATA_TYPE)
1=Device defect|2=Equipment defect|3=Ergonomics|5=Calibration|6=Adjustment|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
340.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Gerät" (LABEL_DE)
1=Gerätemangel|2=Gerätedefekt|3=Ergonomie|5=Kalibrierung|6=Einstellung|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_device2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "condition device"
CL Item
Device defect (1)
CL Item
Equipment defect (2)
Item
abnormality "Condition of software"
integer
observlog_abnorm_webform2 (VAR_NAMES)
abnormality "Condition of software" (LABEL)
integer (DATA_TYPE)
1=Error in application|2=Operation|3=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
342.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Software" (LABEL_DE)
1=Fehler in der Anwendung|2=Bedienung|3=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_webform2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition of software"
CL Item
Error in application (1)
Item
abnormality "condition workplace/room"
integer
observlog_abnorm_room2 (VAR_NAMES)
abnormality "condition workplace/room" (LABEL)
integer (DATA_TYPE)
1=Accessibility|2=order|3=Equipment|4=climate|5=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
344.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Arbeitsplatz/Raum" (LABEL_DE)
1=Begehbarkeit|2=Ordnung|3=Ausstattung|4=Klima|5=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_room2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "condition workplace/room"
CL Item
Accessibility (1)
Item
abnormality "Condition of biomaterials"
integer
observlog_abnorm_others2 (VAR_NAMES)
abnormality "Condition of biomaterials" (LABEL)
integer (DATA_TYPE)
1=Availability|2=Functionality|3=Storage|4=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
346.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Biomaterialien" (LABEL_DE)
1=Verfügbarkeit|2=Funktionalität|3=Lagerung|4=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_others2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition of biomaterials"
CL Item
Functionality (2)
Item
abnormality "Condition consumables"
integer
observlog_abnorm_consumable2 (VAR_NAMES)
abnormality "Condition consumables" (LABEL)
integer (DATA_TYPE)
1=Functionality|2=Availability|3=Storage|4=Disposal|5=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
347.0 (VARIABLE_ORDER)
Auffälligkeit "Zustand Verbrauchsmaterialien" (LABEL_DE)
1=Funktionalität|2=Verfügbarkeit|3=Lagerung|4=Entsorgung|5=Sonstiges (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_consumable2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
abnormality "Condition consumables"
CL Item
Functionality (1)
Item
Rating of the abnormality
integer
observlog_abnorm_rating2 (VAR_NAMES)
Rating of the abnormality (LABEL)
integer (DATA_TYPE)
1=positive|5=neutral - note|2=status unclear|3=quality relevant|4=significantly relevant to quality (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
348.0 (VARIABLE_ORDER)
Wertung der Auffälligkeit (LABEL_DE)
1=positiv|5=neutral - Hinweis|2=Status unklar|3=qualitätsrelevant|4=erheblich qualitätsrelevant (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnorm_rating2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Rating of the abnormality
CL Item
neutral - note (5)
CL Item
status unclear (2)
CL Item
quality relevant (3)
CL Item
significantly relevant to quality (4)
observlog_abnormality_note2
Item
Description of the abnormality
string
observlog_abnormality_note2 (VAR_NAMES)
Description of the abnormality (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
350.0 (VARIABLE_ORDER)
Beschreibung der Auffälligkeit (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_abnormality_note2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Measures planned?
integer
observlog_measures_yn2 (VAR_NAMES)
Measures planned? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
364.0 (VARIABLE_ORDER)
Maßnahmen geplant? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_yn2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Measures planned?
Item
planned measure
integer
observlog_measures2 (VAR_NAMES)
planned measure (LABEL)
integer (DATA_TYPE)
2=Method change/SOP change|1=SOP - Supplement|16=Web form - troubleshooting|4=Web form - change|3=Web form - new function/variable|5=Site Visit - investigator among themselves|6=Site visit - quality manager|7=Site Visit - QV external|8=Training|9=Training - with ARCUS|10=Device exchange/rotation|11=Double examination|12=Plausibility check|14=Hospitation with an experienced examiner|15=Hospitation in the clinic|13=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
366.0 (VARIABLE_ORDER)
geplante Maßnahme (LABEL_DE)
2=Methodenveränderung/SOP-Änderung|1=SOP - Ergänzung|16=Webformular - Fehlerbehebung|4=Webformular - Änderung|3=Webformular - neue Funktion/Variable|5=Site Visit - Untersucher untereinander|6=Site Visit - Qualitätsverantwortlicher|7=Site Visit - QV extern|8=Schulung|9=Training - mit ARCUS|10=Gerätetausch/-rotation|11=Doppeluntersuchung|12=Plausibilitätsprüfung|14=Hospitation bei einem erfahrenen Untersucher|15=Hospitation in der Klinik|13=Sonstige (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
planned measure
CL Item
Method change/SOP change (2)
CL Item
SOP - Supplement (1)
CL Item
Web form - troubleshooting (16)
CL Item
Web form - change (4)
CL Item
Web form - new function/variable (3)
CL Item
Site Visit - investigator among themselves (5)
CL Item
Site visit - quality manager (6)
CL Item
Site Visit - QV external (7)
CL Item
Training - with ARCUS (9)
CL Item
Device exchange/rotation (10)
CL Item
Double examination (11)
CL Item
Plausibility check (12)
CL Item
Hospitation with an experienced examiner (14)
CL Item
Hospitation in the clinic (15)
observlog_measures_report2
Item
Description of planned measures
string
observlog_measures_report2 (VAR_NAMES)
Description of planned measures (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
368.0 (VARIABLE_ORDER)
Beschreibung der geplanten Maßnahmen (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_report2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_measures_implement2
Item
Method change since:
datetime
observlog_measures_implement2 (VAR_NAMES)
Method change since: (LABEL)
datetime (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
370.0 (VARIABLE_ORDER)
Methodenveränderung seit: (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_implement2 (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Further measure planned?
integer
observlog_measures_yn2_other (VAR_NAMES)
Further measure planned? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
374.0 (VARIABLE_ORDER)
Weitere Maßnahme geplant? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_yn2_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Further measure planned?
Item
planned measure
integer
observlog_measures2_other (VAR_NAMES)
planned measure (LABEL)
integer (DATA_TYPE)
2=Method change/SOP change|1=SOP - Supplement|16=Web form - troubleshooting|4=Web form - change|3=Web form - new function/variable|5=Site Visit - investigator among themselves|6=Site visit - quality manager|7=Site Visit - QV external|8=Training|9=Training - with ARCUS|10=Device exchange/rotation|11=Double examination|12=Plausibility check|14=Hospitation with an experienced examiner|15=Hospitation in the clinic|13=Other (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
376.0 (VARIABLE_ORDER)
geplante Maßnahme (LABEL_DE)
2=Methodenveränderung/SOP-Änderung|1=SOP - Ergänzung|16=Webformular - Fehlerbehebung|4=Webformular - Änderung|3=Webformular - neue Funktion/Variable|5=Site Visit - Untersucher untereinander|6=Site Visit - Qualitätsverantwortlicher|7=Site Visit - QV extern|8=Schulung|9=Training - mit ARCUS|10=Gerätetausch/-rotation|11=Doppeluntersuchung|12=Plausibilitätsprüfung|14=Hospitation bei einem erfahrenen Untersucher|15=Hospitation in der Klinik|13=Sonstige (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures2_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
planned measure
CL Item
Method change/SOP change (2)
CL Item
SOP - Supplement (1)
CL Item
Web form - troubleshooting (16)
CL Item
Web form - change (4)
CL Item
Web form - new function/variable (3)
CL Item
Site Visit - investigator among themselves (5)
CL Item
Site visit - quality manager (6)
CL Item
Site Visit - QV external (7)
CL Item
Training - with ARCUS (9)
CL Item
Device exchange/rotation (10)
CL Item
Double examination (11)
CL Item
Plausibility check (12)
CL Item
Hospitation with an experienced examiner (14)
CL Item
Hospitation in the clinic (15)
observlog_measures_rep2_other
Item
Description of planned measure
string
observlog_measures_rep2_other (VAR_NAMES)
Description of planned measure (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
378.0 (VARIABLE_ORDER)
Beschreibung der geplanten Maßnahme (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_rep2_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_measures_imp2_other
Item
Method change since
datetime
observlog_measures_imp2_other (VAR_NAMES)
Method change since (LABEL)
datetime (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
380.0 (VARIABLE_ORDER)
Methodenveränderung seit (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_measures_imp2_other (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Item
Evaluation with the examiner has taken place on
datetime
observlog_evaluation_examiner (VAR_NAMES)
Evaluation with the examiner has taken place on (LABEL)
datetime (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
390.0 (VARIABLE_ORDER)
Auswertung mit dem Untersucher ist erfolgt am (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_evaluation_examiner (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
Code List
Evaluation with the examiner has taken place on
Item
Comment?
integer
observlog_remarks (VAR_NAMES)
Comment? (LABEL)
integer (DATA_TYPE)
0=No|1=Yes (VALUE_LABELS)
s4.observlog (STUDY_SEGMENT)
393.0 (VARIABLE_ORDER)
Kommentar? (LABEL_DE)
0=Nein|1=Ja (VALUE_LABELS_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_remarks (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_remarks_note
Item
Which?
string
observlog_remarks_note (VAR_NAMES)
Which? (LABEL)
string (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
395.0 (VARIABLE_ORDER)
Welches? (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_remarks_note (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)
observlog_end
Item
end
datetime
observlog_end (VAR_NAMES)
end (LABEL)
datetime (DATA_TYPE)
s4.observlog (STUDY_SEGMENT)
400.0 (VARIABLE_ORDER)
Ende (LABEL_DE)
OBSERVLOG (REPORT_NAME)
T_OBSERVLOG (TABLE_NAME)
s4.observlog_end (UNIQUE_NAME)
SHIP (SOURCE)
SHIP-4 (DCE)
SHIP|SHIP4|OPD|SHIPCore|OBSERVLOG (HIERARCHY)