Signatures & Delegated Responsibilities

SITE PERSONNEL SIGNATURES & DELEGATED RESPONSIBILITIES Investigator: ______Project: ______Study Site: ______Sponsor: ______

NAME TITLE OR TASK* SIGNATURE INITIALS DATES (PRINT OR TYPE) POSITION CODES (OF WORK ON STUDY) PI’s Codes Initials From: To:

From: To:

From: To: d

e A = Make eligibility/termination decisions E = Evaluate adverse events (cause/severity) Other Tasks** t a

g B = Obtain informed consent F = Prescribe study drugs/devices I= ______e

e C = Direct medical care of subject G = Label and dispense study drug J= ______

D (treatment decisions) K= ______D = Make data entries and corrections H = Maintain drug/device accountability records on CRFs L= ______* s e

i **List all other key protocol tasks, e.g., administer study drug, draw bloods, physical exams, etc. t i l i b i s n o p s e R

Compliments of:

SMART Site Monitoring, Auditing and Review Team VA Cooperative Studies Program Albuquerque, NM 1/30/07

TO BE SIGNED AT SITE CLOSURE: I confirm that this list accurately reflects the delegation of responsibilities during the trial. Investigator Signature: ______Date: 2 0 0 D D M M M Y Y Y Y

Compliments of:

SMART Site Monitoring, Auditing and Review Team VA Cooperative Studies Program Albuquerque, NM 1/30/07