Study Conclusion Form

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

Administrative data

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Study Conclusion
Beschrijving

Study Conclusion

Datatype

text

Date of subject completion or withdrawal
Beschrijving

Date of subject completion or withdrawal

Datatype

date

Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

If YES, mark the primary reason for withdrawal:
Beschrijving

If YES, mark the primary reason for withdrawal:

Datatype

text

Similar models

Study Conclusion Form

  1. StudyEvent: ODM
    1. Study Conclusion Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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)