Site Preparation for FDA Inspection
Notify all parties of impending inspection
Sponsor
IRB/EC
Principal Investigator
Sub-Investigator(s)
Study Coordinator(s)
Pharmacy
Laboratory(ies)
Medical Records
Administration
Legal Counsel
Reception Area Staff
Review FDA Inspection Preparation SOP
FDA Inspection Preparation SOP
Identify work space for the Inspector
Work space
Telephone
Copier
Table
Review staff and clinic schedules
Review staff schedules (vacations, appointments, miscellaneous time off, etc.) to ensure staff availability
Reschedule non-essential visits/meetings if possible
Clinic Equipment
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)
Locate, compile, organize, and review documents for accuracy and completeness
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
Ensure the following has been completed for each participant
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
Locate, compile, organize, and review documents for accuracy and completeness
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)
Locate, compile, organize, and review documents for accuracy and completeness
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
Completion
General comments and observations