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Study conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion details
Description

Study conclusion details

Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

boolean

If YES, complete primary reason for withdrawal
Description

If YES, complete primary reason for withdrawal

1. Adverse event
Description

record details on AE or SAE forms as appropriate)

Data type

boolean

2. Lack of efficacy
Description

Check all that apply. If none, select "No Subreasons"

Data type

text

3. Protocol Deviation
Description

Check all that apply. If none, select "No Subreasons"

Data type

text

4. Subject reached protocol defined stopping criteria
Description

4. Subject reached protocol defined stopping criteria

Data type

text

5. Study closed/terminated
Description

5. Study closed/terminated

Data type

boolean

6. Lost to Follow-Up
Description

6. Lost to Follow-Up

Data type

boolean

7. Investigator discretion, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

8. Withdrew consent, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

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Similar models

Study conclusion

1 forms
  1. StudyEvent: ODM
    1. Study conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study conclusion details
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
Item Group
If YES, complete primary reason for withdrawal
1. Adverse event
Item
1. Adverse event
boolean
Item
2. Lack of efficacy
text
2. Lack of efficacy
Code List
2. Lack of efficacy
CL Item
No subreasons (1)
CL Item
Exacerbation (2)
Item
3. Protocol Deviation
text
3. Protocol Deviation
Code List
3. Protocol Deviation
CL Item
No subreasons (1)
CL Item
Pregnancy (2)
CL Item
Lack of adherence (3)
CL Item
Prohibited medication use (4)
Item
4. Subject reached protocol defined stopping criteria
text
Subject reached protocol defined stopping criteria
Code List
4. Subject reached protocol defined stopping criteria
CL Item
Yes (1)
CL Item
No (2)
CL Item
Liver function test abnormality (3)
5. Study closed/terminated
Item
5. Study closed/terminated
boolean
6. Lost to Follow-Up
Item
6. Lost to Follow-Up
boolean
7. Investigator discretion, specify
Item
7. Investigator discretion, specify
text
8. Withdrew consent, specify
Item
8. Withdrew consent, specify
text
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