CREST-E SIGNATURE FORM
(12/7/07) 10/31/08
116 | 76
NOTE: a signature form is required for each expected study visit and telephone contact whether or not the visit or call was actually performed.
1.1. Visit Completion Status: (Include comment for any answer other than 1 or 7 under
question 3, Comments.)
1 = Within visit window and conducted by investigator (or coordinator if telephone contact).
2 = Within visit window and not conducted by investigator.
3 = Not done (If visit not done enter the target visit date in the header).
4 = Out of visit window and conducted by investigator (or coordinator if telephone contact).
5 = Out of visit window and not conducted by investigator.
6 = Unscheduled Visit
7 = Other (specify)
2 = Within visit window and not conducted by investigator.
3 = Not done (If visit not done enter the target visit date in the header).
4 = Out of visit window and conducted by investigator (or coordinator if telephone contact).
5 = Out of visit window and not conducted by investigator.
6 = Unscheduled Visit
7 = Other (specify)
1.2. Indicate why the subject missed the visit.
1 = Scheduling issue with the subject.
2 = Scheduling issue with the staff.
3 = Family/social issues with the subject.
4 = Subject did not return phone calls to schedule study visit.
5 = Travel Distance
6 = Medical Problems
7 = Military Duty
8 = Financial Issues
9 = Lost to Follow up (complete Conclusion of Study Participation form).
10 = Other:
2 = Scheduling issue with the staff.
3 = Family/social issues with the subject.
4 = Subject did not return phone calls to schedule study visit.
5 = Travel Distance
6 = Medical Problems
7 = Military Duty
8 = Financial Issues
9 = Lost to Follow up (complete Conclusion of Study Participation form).
10 = Other:
1.3. Were all assessments for this visit completed?
If No (0), please note assessments not completed in question 3, Comments.
0 = No1 = Yes
In addition to the assessments covered by the CRFs specific to this visit, the following tasks were
completed at this visit when applicable:
2.1. Status of Concomitant Medication Log:
1 = Updated log at this visit
2 = No data updates to log; log is not blank
3 = Subject has not reported taking any concomitant medications; log is blank
2 = No data updates to log; log is not blank
3 = Subject has not reported taking any concomitant medications; log is blank
2.2. Status of Adverse Event Log:
1 = Updated log at this visit
2 = No data updates to log; log is not blank
3 = Subject has not reported any events; log is blank
2 = No data updates to log; log is not blank
3 = Subject has not reported any events; log is blank
2.3. Reviewed Dose Management Log?
1 = Updated log at this visit
2 = No data updates to log; log is not blank
3 = Subject has not yet started study drug; log is blank
2 = No data updates to log; log is not blank
3 = Subject has not yet started study drug; log is blank
3. Comments: