Study Conclusion Form

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

Administrative data

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Study Conclusion
Beskrivning

Study Conclusion

Datatyp

text

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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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

If YES, mark the primary reason for withdrawal:

Datatyp

text

Similar models

Study Conclusion Form

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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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