FDA Inspection: Preparedness Checklist

Sponsor

IRB/EC

Principal Investigator

Sub-Investigator(s)

Study Coordinator(s)

Pharmacy

Laboratory(ies)

Medical Records

Administration

Legal Counsel

Reception Area Staff

FDA Inspection Preparation SOP

Work space

Telephone

Copier

Table

Review staff schedules (vacations, appointments, miscellaneous time off, etc.) to ensure staff availability

Reschedule non-essential visits/meetings if possible

Ensure temperature logs for applicable clinic equipment are complete and current (refrigerators, freezers, storage cabinets, etc.)

Ensure equipment maintenance and calibration records are available and current (e.g. electronic scales, electronic blood pressure cuff, etc.) (if applicable)

List of Principal Investigator’s current active protocols

Delegation log (list of personnel and delegated study responsibilities; current and signed)

Signature log (list of key site personnel and corresponding signatures; current and signed) (may be combined with the delegation log)

Master Subject Log (list of all subjects including name, contact information, enrollment and completion dates)

Screening Log (names of all participants screened including enrollment date and reason for screen failure if applicable; ensure log is current and legible)

Enrollment Log (if applicable)

Randomization Log (if applicable)

Protocol (all versions)

Protocol amendments and clarification memorandums

IRB/EC approved Informed Consent Forms (all versions including screening consent forms)

Investigator’s Brochure(s) and/or Package Insert(s) (all versions)

IRB/EC initial protocol approval letter

IRB/EC protocol amendment(s) approval letter(s)

IRB/EC continuing review approval letters

IRB/EC approval letter(s) for revised Informed Consent Forms

IRB/EC approval letter(s) for subject recruitment materials (advertisements, videos, handouts to participants, etc.)

Evidence of EAE submission to the IRB/EC/sponsor

Evidence of identification and reporting of protocol violations/deviations to the IRB/EC/sponsor per IRB/EC and protocol requirements

IND Safety Reports/Memos and evidence of submission to the IRB/EC

DSMB summary report(s) and documentation of submission to the IRB/EC

Documentation of protocol registration submission, approval, activation, and deregistration (if applicable)

All correspondence to and from the IRB/EC pertinent to the study

All sponsor correspondence

Any other correspondence pertinent to the study (e.g. protocol team)

Form FDA 1572 (all versions)

Financial Disclosure Forms (Principal Investigator and Sub-Investigators listed on the Form FDA 1572

CVs (Principal Investigator, Sub-Investigators, and other key staff members; current and signed)

Licenses (Principal Investigator, Sub-Investigators, and other key staff members)

Good Clinical Practice/ Human Subjects Protection training documentation for individuals listed on the Form FDA 1572 and any clinical research site personnel who have more than minimal involvement with the conduct of the research

Documentation of staff protocol training

Documentation of additional staff training (if applicable)

Study recruitment and retention plan

Site Standard Operating Procedures

Signed and dated monitoring visit log

Annual CQMP Summary Review submitted to Sponsor.

All monitoring pre-visit letters and monitoring reports

Source documents and medical records are available for each participant (Review for ALCOA) (Alternative: Source documents and corresponding Case Report Forms (CRFs) for each participant are present, clearly identified, and systematically organized in binders or folders for ease of retrieval during the inspection)

Completed Case Report Forms (CRFs) on file for each participant

Original signed and dated Informed Consent Forms on file for each participant

Inclusion/exclusion criteria for each participant have been met and documented

All visits conducted within protocol windows

Correct volume of blood and correct tube type drawn at each visit

Adverse Events (AEs), and Expedited Adverse Events (EAEs) have been identified and documented appropriately

All EAEs have been reported to the IRB/EC

All AEs and EAEs have been reported to the sponsor per study requirements

Protocol endpoints have been identified and reported appropriately

Ensure study product use by all participants has been documented

Protocol-required tests/evaluations have been completed and documented appropriately

Protocol violations/ deviations have been identified and documented appropriately

Concomitant/prohibited medications have been documented and reported appropriately

All laboratory reports and other diagnostic test reports are on file and display correct participant identifiers

All laboratory results have been graded appropriately by the PI or designated medical officer per the DAIDS AE Grading Table and protocol-requirements

Laboratory reports have been signed by the PI or designated medical officer

Premature discontinuations of participants are documented appropriately per study requirements

CV of pharmacist(s)

CVs of key pharmacy personnel

Licenses of pharmacy personnel

Form FDA 1572

Prescriber signature list

Most recent version of the protocol for which the site has IRB/EC approval

Most recent version of the protocol-specific study procedures (i.e. SSP manual)

Records of study product dispensation to appropriate staff member (if applicable)

Most recent version of Investigator’s Brochure(s) or Package Insert(s)

CRPMC Drug Supply Statement (version for which site is protocol registered)

Investigational agent accountability logs

Participant prescriptions

Documentation of study drug transfers, returns, and destruction (if applicable)

Ordering/shipping receipts

Participant-specific profiles (if applicable)

DAIDS-approved, signed Pharmacy Establishment Plan

Required pharmacy operations SOPs as listed in the PAB Pharmacy Guidelines (July 2008)

CV of Laboratory Director

CVs of key laboratory personnel

Licenses of laboratory personnel (if applicable)

Laboratory certifications

Laboratory normal ranges

Laboratory Data Management System (LDMS) records

Copies of laboratory audits, action plans, and corrective action reports

Specimen logs (present and readily available for review)

Chain of Custody SOP (or similar process document)

Corresponding control data for assays where laboratory result AEs and EAEs were identified

Temperature logs for applicable equipment (refrigerators, freezers, storage cabinets, etc.)

Calibration and maintenance records for all laboratory equipment (if applicable)

Corrective action reports for identified temperature excursions

Vertical audit of laboratory results and corresponding QC data for results of a randomly selected sample