Download Study Management Checklist

Study Management Checklist
Protocol:
PROTOCOL/STUDY MANAGEMENT- PRE-INITIATION
DOCUMENTATION
Qualification Visit documentation
Standard Operation Procedures and/or internal departmental procedures/processes
Signed Form FDA 1572
CVs of investigators listed on the 1572 and all team members
Signed Financial Disclosure Forms
Signed Conflict of Interest Statements
Documentation of Research Ethics; Protocol and GCP Training (if applicable)
Signed protocol
Investigator's brochure
IRB approval/correspondence
IRB approved consent form
IRB membership roster
Laboratory certification and normal values

ADMINISTRATIVE
Investigator Agreements
Confidentiality Agreements
Contract
Budget

SET UP SUBJECT RECRUITMENT
Department meetings
Advertisements
Letters to physicians

CONTACTS AND INSERVICE
Pharmacy
Nursing
Physicians
Laboratory
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Study Management Checklist
Protocol:

PROTOCOL PREPARATION
Visit worksheets
Patient log
Protocol summary (contacts, purpose, inclusion and exclusion criteria)
Drug administration summary (contacts, adverse effects, administration)
Special lab work requisitions (if required)
Pre-printed physicians orders, as appropriate
Randomization table, as appropriate
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
Copies of Adverse/Unanticipated Events/Protocol Violation/Deviation/Waiver/Exception to IRB,
IRB acknowledgement of receipt
Monitoring Visit pre and post visit letters
Data Queries requested and completed
Copies of, or completed Case Report/Data Collection Forms (all versions)
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Study Management Checklist
Protocol:

DRUG LOGS
File shipping records
Drug accountability records updated as appropriate

SPECIMEN LOGS
Specimen shipping records
Specimen storage records
Temperature Logs

CORRESPONDENCE / MEETINGS
Copies of all letters written and received on file
Site visit logs on file
Telephone logs maintained
Internal correspondence, meeting minutes, training – re-training documentation
Newsletters

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 and/or indentifying information
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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
IRB and other departments notified in writing
Completed Data Fax forms
Data Query Resolution
Data lock
Prepartion of Records for Archiving
Master Subject Logs Current
Code breaks appropriately documented
Unblind Team members
Archived or Destroyed Specimen Storage
Study Documents long term storage
Budget revenue received; appropriately billed for; payments made; and all information recorded
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