Document Name and Accession

Document Name: CREST-E SIGNATURE FORM
Document Accession: phd007426.1

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CREST-E SIGNATURE FORM

(12/7/07) 10/31/08

116 | 76

SUBJECT ID VISIT NO
INITIALS SITE NO VISIT DATE MM DD YYYY

NOTE: a signature form is required for each expected study visit and telephone contact whether or not the visit or call was actually performed.

Link to associated variable1.1. 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)
Link to associated variable1.2. 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:
Link to associated variable1.3. 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:
Link to associated variable2.1. 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
Link to associated variable2.2. 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
Link to associated variable2.3. 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
Link to associated variable2.4. Reviewed Drug Return and Accountability 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
3. Comments:

I have reviewed the data entries for this visit and determined that they are complete, accurate, and consistent with source documents, if available. All entries were made by me, or by a person who is under my supervision.

INVESTIGATOR'S SIGNATURE
DATE
STAFF CODE
COORDINATOR'S SIGNATURE
DATE
STAFF CODE