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ID

29571

Descrizione

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains the "end of study" form (except for Adverse Events, see Form "Adverse Events").

collegamento

https://clinicaltrials.gov/ct2/show/NCT00318630

Keywords

versioni (1)
  1. 06/04/18 06/04/18 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

6 aprile 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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    GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

    Inglese

    End of Study

    1 moduli  
    1. StudyEvent: ODM
      1. End of Study
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Volunteer Identifier
    Descrizione

    Volunteer Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1300638
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    Status of treatment blind
    Descrizione

    Status of treatment blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind broken during the study?
    Descrizione

    If yes, complete date, time and reason blind was broken.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C0449438
    Date blind broken
    Descrizione

    If blind was broken.

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Time blind broken
    Descrizione

    If blind was broken.

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0040223
    Reason blind broken
    Descrizione

    If blind was broken. If Z = other, please specify in item "other reason blind broken, specify". Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    other reason blind broken, specify
    Descrizione

    other reason blind broken

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0947611
    PGx-Pharmacogenetic Research
    Descrizione

    PGx-Pharmacogenetic Research

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0008976
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Descrizione

    If yes, please give the date. If the question is answered No, pick one reason and do not complete the remainder of the page. should be completed at any time between Visits Screening and Follow-up

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    date informed consent obtained for PGx-Pharmacogenetic research
    Descrizione

    If Yes in the item "consent for PGx-pharmacogenetic research", record the date informed consent obtained for PGx-Pharmacogenetic research

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0011008
    If no, pick one reason.
    Descrizione

    if no in the item "consent for PGx-pharmacogenetic research", pick one reason. If Z = other, specify in the "other reason, specify" item.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0392360
    other reason, specify
    Descrizione

    If Z = other reason was picked in the item "Reason for no consent for pharmacogenetic research", please specify.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [1,4]
    C2347500
    Has a blood sample been collected for PGx-pharmacogenetic research?
    Descrizione

    If yes, record the date sample taken.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031325
    Blood sample collection date
    Descrizione

    If a blood sample was taken for pharmacogenetic research.

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0031325
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Descrizione

    Must be completed immediately, if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section completed.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0031325
    Has a request been made for sample destruction?
    Descrizione

    Must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research. If the question is answered Yes, pic one reason.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0031325
    If yes, pick one reason.
    Descrizione

    If yes in the item "blood sample destruction", please pick one reason. If Z = other reason, specify in the item "other reason for blood sample destruction".

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0031325
    UMLS CUI [1,4]
    C0392360
    other reason for blood sample destruction, specify
    Descrizione

    If Z = other reason in item "reason for blood sample destruction", specify.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0031325
    UMLS CUI [1,4]
    C0392360
    UMLS CUI [1,5]
    C0947611
    Concomitant Medication
    Descrizione

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Descrizione

    If Yes, fill in each item for each medication using Trade Names where possible.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2347852
    Drug Name
    Descrizione

    Trade name preferred. Ensure that the spelling of the Drug Name(s) is correct.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2360065
    Unit Dose
    Descrizione

    Unit Dose

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C2826811
    Units
    Descrizione

    Units

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826646
    Frequency
    Descrizione

    Frequency

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826654
    Route
    Descrizione

    Route

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    Reason for Medication
    Descrizione

    Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: * Current Medical Conditions * Non-Serious Adverse Events * Serious Adverse Events Form

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826696
    Start Date
    Descrizione

    Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2826734
    Start Time
    Descrizione

    Start Time

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1301880
    Taken prior to study?
    Descrizione

    Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1514463
    Stop Date
    Descrizione

    Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2826744
    Stop Time
    Descrizione

    Stop Time

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C2347852
    Ongoing Medication
    Descrizione

    Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826666
    Pregnancy Information
    Descrizione

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study?
    Descrizione

    If Yes, complete Pregnancy Notification form.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    Study Conclusion
    Descrizione

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Date of subject completion or withdrawal
    Descrizione

    If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0805732
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0422727
    Time of withdrawal
    Descrizione

    Time of withdrawal

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0040223
    Was the subject withdrawn from the study?
    Descrizione

    If Yes, pick the primary reason for withdrawal in the item "Reason for withdrawal"

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0422727
    If Yes, pick the primary reason for withdrawal:
    Descrizione

    If the investigational product was discontinued at the same time as the subject was withdrawn from the study, ensure the reasons for the two discontinuations are consistent. Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event: * ’Withdrawal’ on the AE/SAE page is recorded as ’Yes’. * ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE/SAE’ on the AE/SAE page is recorded as ’Investigational Product Withdrawn’. * ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’. If Z = other is picked, please fill in the item "other reason for withdrawal"

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    Other reason for withdrawal, specify
    Descrizione

    Other Reason for withdrawal

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    Investigator Comment Log
    Descrizione

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    CRF page number, if applicable
    Descrizione

    CRF page number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Descrizione

    Only use this form to record explanatory information on anomalies such as missing data, sponsor waiver of inclusion/exclusion criteria, departures from planned investigational product administration or missed visits.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0947611
    Investigator's signature
    Descrizione

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    Descrizione

    The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Descrizione

    Date of signature

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator's name (print)
    Descrizione

    Investigator's name

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826892
    Ritorna all'inizio della pagina

    Similar models

    End of Study

    1 moduli
    1. StudyEvent: ODM
      1. End of Study
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Volunteer Identifier
    Item
    Volunteer Identifier
    text
    C1300638 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Status of treatment blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Item
    Was the treatment blind broken during the study?
    text
    C2347038 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Status of treatment blind
    Code List
    Was the treatment blind broken during the study?
    CL Item
    yes (y)
    CL Item
    no (n)
    Date blind broken
    Item
    Date blind broken
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time blind broken
    Item
    Time blind broken
    time
    C3897431 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Reason blind broken
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken
    CL Item
    Medical emergerncy requiring identification of investigational product for further treatment. (1)
    CL Item
    other (Z)
    other reason blind broken
    Item
    other reason blind broken, specify
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    PGx-Pharmacogenetic Research
    C2347500 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Consent for PGx-pharmacogenetic research
    Code List
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Date of consent for pharmacogenetic research
    Item
    date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If no, pick one reason.
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Reason for no consent for pharmacogenetic research
    Code List
    If no, pick one reason.
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by investigator (2)
    CL Item
    other reason (Z)
    other reason, specify
    Item
    other reason, specify
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    Item
    Has a blood sample been collected for PGx-pharmacogenetic research?
    text
    C0005834 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Blood sample collection (DNA)
    Code List
    Has a blood sample been collected for PGx-pharmacogenetic research?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Blood sample collection date
    Item
    Blood sample collection date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0031325 (UMLS CUI [1,3])
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    text
    C1707492 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Consent for PGx-pharmacogenetic research
    Code List
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item
    Has a request been made for sample destruction?
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0031325 (UMLS CUI [1,3])
    Consent for PGx-pharmacogenetic research
    Code List
    Has a request been made for sample destruction?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item
    If yes, pick one reason.
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0031325 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    Consent for PGx-pharmacogenetic research
    Code List
    If yes, pick one reason.
    CL Item
    Subject requested (1)
    CL Item
    Screen failure (2)
    CL Item
    other reason (Z)
    Item
    other reason for blood sample destruction, specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0031325 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0947611 (UMLS CUI [1,5])
    Consent for PGx-pharmacogenetic research
    Code List
    other reason for blood sample destruction, specify
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Item
    Were any concomitant medications taken by the subject during the study?
    text
    C2347852 (UMLS CUI [1])
    Consent for PGx-pharmacogenetic research
    Code List
    Were any concomitant medications taken by the subject during the study?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Unit Dose
    Item
    Unit Dose
    float
    C2826811 (UMLS CUI [1])
    Item
    Units
    text
    C2826646 (UMLS CUI [1])
    Unit Dose
    Code List
    Units
    CL Item
    Tablet (TAB)
    CL Item
    Microlitre (MCL)
    CL Item
    Millilitre (ML)
    CL Item
    Litre (L)
    CL Item
    Microgram (MCG)
    CL Item
    Milligram (MG)
    CL Item
    Gram (G)
    Item
    Frequency
    text
    C2826654 (UMLS CUI [1])
    Frequency
    Code List
    Frequency
    CL Item
    1 x Daily (OD/QD)
    CL Item
    2 x Daily (BID)
    CL Item
    3 x Daily (TID)
    CL Item
    4 x Daily (QID)
    CL Item
    As required (PRN)
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Route
    Code List
    Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Topical (TP)
    CL Item
    Oral (PO)
    CL Item
    Vaginal (VG)
    Reason for Medication
    Item
    Reason for Medication
    text
    C2826696 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Start Time
    Item
    Start Time
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item
    Taken prior to study?
    text
    C2347852 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    Taken prior to study?
    Code List
    Taken prior to study?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Stop Date
    Item
    Stop Date
    date
    C2826744 (UMLS CUI [1])
    Stop Time
    Item
    Stop Time
    time
    C1522314 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item
    Ongoing Medication
    text
    C2826666 (UMLS CUI [1])
    Consent for PGx-pharmacogenetic research
    Code List
    Ongoing Medication
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Pregnancy during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    yes (Y)
    CL Item
    no (N)
    CL Item
    Not applicable (not of childbearing potential or male) (X)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C0011008 (UMLS CUI [1,1])
    C0805732 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0422727 (UMLS CUI [2,2])
    Time of withdrawal
    Item
    Time of withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Consent for PGx-pharmacogenetic research
    Code List
    Was the subject withdrawn from the study?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item
    If Yes, pick the primary reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Reason for withdrawal
    Code List
    If Yes, pick the primary reason for withdrawal:
    CL Item
    Adverse event (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    other (Z)
    Other Reason for withdrawal
    Item
    Other reason for withdrawal, specify
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    CRF page number
    Item
    CRF page number, if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator's name
    Item
    Investigator's name (print)
    text
    C2826892 (UMLS CUI [1])
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