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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 SOP Work 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 completeness List 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 Procedures Signed 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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