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FDA Inspection Template

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FDA Inspection Template

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Administrative

Notify all parties of impending inspection

IRB/EC

Sponsor

Principal Investigator

Sub-Investigator(s)

Study Coordinator(s)

Pharmacy

Medical Records

Laboratory(ies)

Administration

Reception Area Staff

Legal Counsel

Review FDA Inspection Preparation SOP

FDA Inspection Preparation SOP

FDA Inspection Preparation SOPWork space

Copier

Table

Telephone

Review staff and clinic schedules

Reschedule non-essential visits/meetings if possible

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

Clinic Equipment

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

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

Regulatory

Locate, compile, organize, and review documents for accuracy and completenessList of Principal Investigator’s current active protocols

Locate, compile, organize, and review documents for accuracy and completeness

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

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

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)

Randomization Log (if applicable)

Protocol amendments and clarification memorandums

Protocol (all versions)

Enrollment Log (if applicable)

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

IRB/EC initial protocol approval letter

IRB/EC continuing review approval letters

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

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

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

Evidence of EAE submission to the IRB/EC/sponsor

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

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

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

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

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

All sponsor correspondence

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

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

Form FDA 1572 (all versions)

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

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

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

Documentation of additional staff training (if applicable)

Documentation of staff protocol training

Study recruitment and retention plan

Site Standard Operating Procedures

Annual CQMP Summary Review submitted to Sponsor.

Site Standard Operating ProceduresSigned and dated monitoring visit log

All monitoring pre-visit letters and monitoring reports

Documentation

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)

Ensure the following has been completed for each participant

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

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

All visits conducted within protocol windows

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

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

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

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

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

Ensure study product use by all participants has been documented

Concomitant/prohibited medications have been documented and reported appropriately

Protocol violations/ deviations have been identified and documented appropriately

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

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

Premature discontinuations of participants are documented appropriately per study requirements

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

Pharmacy

CV of pharmacist(s)

Licenses of pharmacy personnel

Locate, compile, organize, and review documents for accuracy and completeness

CVs of key pharmacy personnel

Form FDA 1572

Prescriber signature list

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

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

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

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

Investigational agent accountability logs

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

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

Participant prescriptions

Documentation of study drug transfers, returns, and destruction (if applicable)Ordering/shipping receipts

DAIDS-approved, signed Pharmacy Establishment Plan

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

Participant-specific profiles (if applicable)

Laboratory

Licenses of laboratory personnel (if applicable)

Locate, compile, organize, and review documents for accuracy and completeness

Laboratory certifications

CVs of key laboratory personnel

Laboratory normal ranges

Laboratory Data Management System (LDMS) records

CV of Laboratory Director

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)

Chain of Custody SOP (or similar process document)

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

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

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

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

Corrective action reports for identified temperature excursions

Completion

General comments and observations

Sign off

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