Study Management Checklist
Protocol:
PROTOCOL MANAGEMENT.- PRE-INITIATION
DOCUMENTATION
 IRB REPORTS
Signed Form FDA 1572
Annual (or as required by IRB) report submitted prior to expiration date
CVs of investigators listed on the 1572
Copy of annual report kept on file
Signed protocol
IRB
approval forbrochure
continuation on file
Investigator's
IRB approval/correspondence
ADVERSE EXPERIENCE (AE) REPORTS
Report toIRB
sponsor
within
time frame
defined inroster
protocol
letter of
assurance/
membership
-telephone and written
IRB approved consent form
Copy of report on file
Laboratory certification and normals
Follow-up report to sponsor when AE resolves
 ADMINISTRATIVE
Copy of Contract
follow-up report on file

Letter toBudget
IRB regarding the AE, attach copy of AE report as appropriate
of UP
letter
to IRB onRECRUITMENT
file
 Copy
SET
SUBJECT
Department meetings
Advertisements
Letters to physicians

CONTACTS AND INSERVICE
Pharmacy
Nursing
Physicians
Laboratory

PROTOCOL PREPARATION
Visit worksheets
Patient log
Protocol summary (contacts, purpose, inclusion and exclusion criteria)
Drug administration summary (contacts, adverse effects, administration)
Special labwork requisitions (if required)
Pre-printed physicians orders, as appropriate
Randomization table, as appropriate
rev: 6/12/2003
Study Management Checklist
Protocol:
PROTOCOL MANAGEMENT: ACTIVE STUDY
CHANGES IN INVESTIGATORS, LABORATORIES, ETC., LISTED ON FORM 1572
Form FDA 1572 revised and signed
IRB notified of the change
IRB approval of the change
Copy of revised 1572 and IRB notification and approval in study files

PROTOCOL CHANGES/AMENDMENTS AND SAFETY UPDATES
Investigator signed amendment and copy sent to sponsor
Letter to IRB notifying them of each revision or update
Approval letter for each revision received from IRB prior to instituting change
Consent form revised to reflect the changes, as applicable
Changed consent approved by IRB
IRB activity log updated
Copies of letters to IRB, IRB approval and approved revised consent on file
Copies of IRB approval sent to sponsor

DRUG LOGS
File shipping records
Drug accountability records updated as appropriate

CORRESPONDENCE / MEETINGS
Copies of all letters written and received on file
Site visit logs on file
Telephone logs maintained

SENSITIVE DATA (TO BE KEPT IN A SECURE AREA WITH LIMITED ACCESS)
Copies of informed consent from each patient on file
Laboratory data (EKGS, blood tests, etc.) that contain patient identifiers
Patient logs
Any document that contains a patient name
rev: 6/12/2003
Study Management Checklist
Protocol:
PROTOCOL MANAGEMENT: STUDY CLOSE OUT
Copies of all regulatory documents as listed in previous pages on file
Drug inventory completed, including drug return forms
Return drug to sponsor or as directed
Case report forms completed, signed, and copies to sponsor
Data entry and clean-up completed, as appropriate
Ship any remaining banked specimens
rev: 6/12/2003