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Study conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion details
Descrição

Study conclusion details

Date of subject completion or withdrawal
Descrição

Date of subject completion or withdrawal

Tipo de dados

date

Was the subject withdrawn from the study?
Descrição

Was the subject withdrawn from the study?

Tipo de dados

boolean

If YES, complete primary reason for withdrawal
Descrição

If YES, complete primary reason for withdrawal

1. Adverse event
Descrição

record details on AE or SAE forms as appropriate)

Tipo de dados

boolean

2. Lack of efficacy
Descrição

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

Tipo de dados

text

3. Protocol Deviation
Descrição

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

Tipo de dados

text

4. Subject reached protocol defined stopping criteria
Descrição

4. Subject reached protocol defined stopping criteria

Tipo de dados

text

5. Study closed/terminated
Descrição

5. Study closed/terminated

Tipo de dados

boolean

6. Lost to Follow-Up
Descrição

6. Lost to Follow-Up

Tipo de dados

boolean

7. Investigator discretion, specify
Descrição

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

Tipo de dados

text

8. Withdrew consent, specify
Descrição

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

Tipo de dados

text

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Similar models

Study conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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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