Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
ID of patient
text
C2348585 (UMLS CUI [1])
Item
Protocol violation:
text
C1709750 (UMLS CUI [1])
Code List
Protocol violation:
CL Item
Inclusion/Exclusion criteria (1)
CL Item
Therapy process/ trial process (2)
CL Item
Information given by not authorized medical personal (4)
CL Item
Other problems with informed consent (5)
Date of protocol violation
Item
Date of protocol violation
date
C0011008 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
Description of Protocol Violation
Item
Description of Protocol Violation
text
C1709750 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Reason for Protocol Violation
Item
Reason for Protocol Violation
text
C1709750 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Medical Procedure
Item
Planned/ performed medical procedure
text
C0199171 (UMLS CUI [1])
Item
Proven by:
text
C0456369 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
CL Item
ward physician (2)
CL Item
authorized medical personal (7)
Proven date
Item
Proven: Date
date
C0456369 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature
Item
Signature of examiner/ authorized medical personal
text
C1519316 (UMLS CUI [1])
Item
Assessment of protocol violation: (evaluation should be performed after consultation with biometrics and/or LKP)
text
C1709750 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Code List
Assessment of protocol violation: (evaluation should be performed after consultation with biometrics and/or LKP)
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Name of project manager
Item
Name of project manager
text
C0027365 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
Signature of project manager
Item
Signature of project manager
text
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])