Study Conclusion Form

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

Administrative data

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Study Conclusion
Descripción

Study Conclusion

Tipo de datos

text

Date of subject completion or withdrawal
Descripción

Date of subject completion or withdrawal

Tipo de datos

date

Was the subject withdrawn from the study?
Descripción

Was the subject withdrawn from the study?

Tipo de datos

boolean

If YES, mark the primary reason for withdrawal:
Descripción

If YES, mark the primary reason for withdrawal:

Tipo de datos

text

Similar models

Study Conclusion Form

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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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