FDA Inspection: Preparedness Checklist

• Company / Facility

• Conducted on

  Date

• Prepared by

• Location
  Address

Administrative

• Notify all parties of impending inspection

• Sponsor

  Done

  To Do

  Not Applicable

• IRB/EC

  Done

  To Do

  Not Applicable

• Principal Investigator

  Done

  To Do

  Not Applicable

• Sub-Investigator(s)

  Done

  To Do

  Not Applicable

• Study Coordinator(s)

  Done

  To Do

  Not Applicable

• Pharmacy

  Done

  To Do

  Not Applicable

• Laboratory(ies)

  Done

  To Do

  Not Applicable

• Medical Records

  Done

  To Do

  Not Applicable

• Administration

  Done

  To Do

  Not Applicable

• Legal Counsel

  Done

  To Do

  Not Applicable

• Reception Area Staff

  Done

  To Do

  Not Applicable

• Review FDA Inspection Preparation SOP

• FDA Inspection Preparation SOP

  Done

  To Do

  Not Applicable

• Identify work space for the Inspector

• Work space

  Done

  To Do

  Not Applicable

• Telephone

  Done

  To Do

  Not Applicable

• Copier

  Done

  To Do

  Not Applicable

• Table

  Done

  To Do

  Not Applicable

• Review staff and clinic schedules

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

  Done

  To Do

  Not Applicable

• Reschedule non-essential visits/meetings if possible

  Done

  To Do

  Not Applicable

• Clinic Equipment

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

Regulatory

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

• List of Principal Investigator’s current active protocols

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Enrollment Log (if applicable)

  Done

  To Do

  Not Applicable

• Randomization Log (if applicable)

  Done

  To Do

  Not Applicable

• Protocol (all versions)

  Done

  To Do

  Not Applicable

• Protocol amendments and clarification memorandums

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• IRB/EC initial protocol approval letter

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• IRB/EC continuing review approval letters

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Evidence of EAE submission to the IRB/EC/sponsor

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• All sponsor correspondence

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Form FDA 1572 (all versions)

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• 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

  Done

  To Do

  Not Applicable

• Documentation of staff protocol training

  Done

  To Do

  Not Applicable

• Documentation of additional staff training (if applicable)

  Done

  To Do

  Not Applicable

• Study recruitment and retention plan

  Done

  To Do

  Not Applicable

• Site Standard Operating Procedures

  Done

  To Do

  Not Applicable

• Signed and dated monitoring visit log

  Done

  To Do

  Not Applicable

• Annual CQMP Summary Review submitted to Sponsor.

  Done

  To Do

  Not Applicable

• All monitoring pre-visit letters and monitoring reports

  Done

  To Do

  Not Applicable

Clinical

• 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)

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• All visits conducted within protocol windows

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• All EAEs have been reported to the IRB/EC

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Protocol endpoints have been identified and reported appropriately

  Done

  To Do

  Not Applicable

• Ensure study product use by all participants has been documented

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Protocol violations/ deviations have been identified and documented appropriately

  Done

  To Do

  Not Applicable

• Concomitant/prohibited medications have been documented and reported appropriately

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Premature discontinuations of participants are documented appropriately per study requirements

  Done

  To Do

  Not Applicable

Pharmacy

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

• CV of pharmacist(s)

  Done

  To Do

  Not Applicable

• CVs of key pharmacy personnel

  Done

  To Do

  Not Applicable

• Licenses of pharmacy personnel

  Done

  To Do

  Not Applicable

• Form FDA 1572

  Done

  To Do

  Not Applicable

• Prescriber signature list

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Investigational agent accountability logs

  Done

  To Do

  Not Applicable

• Participant prescriptions

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Ordering/shipping receipts

  Done

  To Do

  Not Applicable

• Participant-specific profiles (if applicable)

  Done

  To Do

  Not Applicable

• DAIDS-approved, signed Pharmacy Establishment Plan

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

Laboratory

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

• CV of Laboratory Director

  Done

  To Do

  Not Applicable

• CVs of key laboratory personnel

  Done

  To Do

  Not Applicable

• Licenses of laboratory personnel (if applicable)

  Done

  To Do

  Not Applicable

• Laboratory certifications

  Done

  To Do

  Not Applicable

• Laboratory normal ranges

  Done

  To Do

  Not Applicable

• Laboratory Data Management System (LDMS) records

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Specimen logs (present and readily available for review)

  Done

  To Do

  Not Applicable

• Chain of Custody SOP (or similar process document)

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• Corrective action reports for identified temperature excursions

  Done

  To Do

  Not Applicable

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

  Done

  To Do

  Not Applicable

• General comments and observations

• Sign off

  Sign