Study Conclusion Form

  1. StudyEvent: ODM
    1. Study Conclusion Form
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

Study Conclusion
Description

Study Conclusion

Data type

text

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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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, mark the primary reason for withdrawal:
Description

If YES, mark the primary reason for withdrawal:

Data type

text

Similar models

Study Conclusion Form

  1. StudyEvent: ODM
    1. Study Conclusion Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Study Conclusion
Item
Study Conclusion
text
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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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
If YES, mark the primary reason for withdrawal:
text
Code List
If YES, mark the primary reason for withdrawal:
CL Item
[1] Adverse event -> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
CL Item
[2] Lost to follow-up (2)
CL Item
[3] Protocol violation (3)
CL Item
[4] Subject decided to withdraw from the study (4)
CL Item
[6] Sponsor terminated study (5)
CL Item
[Z] Other, specify______________________________ (6)