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Study conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion details
Beskrivning

Study conclusion details

Date of subject completion or withdrawal
Beskrivning

Date of subject completion or withdrawal

Datatyp

date

Was the subject withdrawn from the study?
Beskrivning

Was the subject withdrawn from the study?

Datatyp

boolean

If YES, complete primary reason for withdrawal
Beskrivning

If YES, complete primary reason for withdrawal

1. Adverse event
Beskrivning

record details on AE or SAE forms as appropriate)

Datatyp

boolean

2. Lack of efficacy
Beskrivning

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

Datatyp

text

3. Protocol Deviation
Beskrivning

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

Datatyp

text

4. Subject reached protocol defined stopping criteria
Beskrivning

4. Subject reached protocol defined stopping criteria

Datatyp

text

5. Study closed/terminated
Beskrivning

5. Study closed/terminated

Datatyp

boolean

6. Lost to Follow-Up
Beskrivning

6. Lost to Follow-Up

Datatyp

boolean

7. Investigator discretion, specify
Beskrivning

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

Datatyp

text

8. Withdrew consent, specify
Beskrivning

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

Datatyp

text

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Similar models

Study conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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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