10-CBA DELEGATION OF RESPONSIBILITY & STAFF SIGNATURE LOG

CIBMTR CENTER #      CENTER NAME       PI Name:      

Designee Full Name(printed)

Title(PI, Sub-I,

coordinator, data manager, etc.)

Designee Initials

Designee Signature Delegated Activities(see codes

below)

Effective Date

End Date

# of years clinical

research experience

Completion date ofHuman Subjects

Protection training

Study Activity Codes: 1. Medical History/ Physical Exam (Patient Care)2. Drug Dispensing/Accountability3. Query Resolution

4. Recruiting/screening5. Consenting/enrollment 6. Data collection (direct subject contact)7. Adverse Event Assessment (Physician only)

8. Study form Completion (including unscheduled forms)9. Maintaining study files 10. Other-specify

Investigator’s Authorization: As Principal Investigator for the above mentioned investigational trial, I authorize the above staff to assume the indicated responsibilities. I understand that this in no way alters my responsibilities as defined in the Code of Federal Regulations, Title 21 CFR Part 50, 56 and 312.

Investigator’s Signature: Date: _________________

In the case of log revisions, please re-sign and date:

Investigator’s Signature: Date: _________________

Investigator’s Signature: Date: _________________