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PREPARING FOR AN FDA AUDIT. ANDREA BRANCHE INVESTIGATOR USFDA Houston Resident Post Dallas District. The Inspection Process: Perspective and Approach. Purpose is quality assurance, not quality control/monitoring

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Preparing for an fda audit





Houston Resident Post

Dallas District

The inspection process perspective and approach
The Inspection Process: Perspective and Approach

Purpose is quality assurance, not quality control/monitoring

Inspections must serve both a compliance function as well as a review function

Individual sites serve as indicators of system controls

  • Supplemented, as appropriate, with inspections of sponsor/monitor/CRO

What defines gcp in the united states
What Defines GCP in the United States

FDA has GCP regulations governing the approval, conduct, review and reporting of clinical research intended for submission

  • 21 CFR 312: IND regulations (rev.1987)

  • 21 CFR 50: Informed consent (rev.1981)

  • 21 CFR 56: IRB (rev.1981)

  • 21 CFR 314: NDA regulations (rev. 1985)

    These are legally enforceable requirements

Routine vs directed inspections
Routine vs. Directed Inspections


  • Inspections assigned for PMA’s and NDA’s

    Directed (“for cause”)

  • Problems identified during review process

  • Complaints reported to DSI

    • FDA, other Agencies

    • Sponsors/monitors

    • Institutions/IRB’s

    • Subjects/Public

Directed inspection criteria
Directed Inspection Criteria

Suspicion of false or fraudulent data

Data that appear unrealistic

Evidence that a sponsor has rejected data from an investigator

Evidence of delay in submitting adverse clinical findings

Evidence of inadequately monitored clinical investigations

Evidence of inadequate or inappropriate informed consent

Evidence of delayed or inappropriate IRB approval

Evidence that an investigator has a significant financial interest in the product

Inspection programs gcp
Inspection Programs: GCP

Clinical Investigator

  • Inspections assigned for each pending NDA/PMA

  • Supplements are routinely inspected only when there is a significant public health impact (eg., significant new indication; significant new population); justification is required in the request

  • May be assigned for active IDE/IND, if indicated

How we do it
How We Do It!!!!

Clinical investigator inspections usually done by appointment

Opening interview with investigator and study coordinator(s)

Facilities inspection

Record review

Periodic discussion with investigator, sub-investigators, study coordinator, technicians, laboratory personnel

Pharmacy records/drug accountability review

Exit interview - conveyance of FDA 483 inspection findings to investigator of record (or his/her designee)


Opening interview with investigator and study coordinator(s)

  • Emphasis on understanding who did what; how specific study taks may have been delegated

  • To what extent did the investigator of record maintain control over the study

  • How were subjects screened and allocated to treatment groups

  • Who was responsible for determining subject eligibility and at what point in the study was this accomplished

  • What degree of unblinding occurred


  • How compliant were the study subjects with the protocol

  • What notable serious or unexpected adverse experiences occurred

  • Can the investigator identify sources of bias in the study

  • What is the completeness of required documentation

  • Can the investigator identify difficulties with the study and/or CRF design that made the protocol difficult to follow

  • If the study were to be repeated, what would the investigator do differently


Record keeping: What is the completeness of required documentation?

  • Not just paper! FDA inspectors can ask to see actual x-ray films, ultrasound recordings, pulmonary function test tracings, and other true “source” materials to substantiate data submitted in CRFs

  • Are consent forms available for all subjects? Do they bear signature dates prior to the subjects’s start of participation in the trial?

    • Are investigator copies of CRFs present for all subjects?

    • Are supporting medical records/source documents available for all subjects?

    • What is the nature of original documentation for study-specific procedures, such as biopsy reports, special tests?

  • Source data

    Medical history information

    Medical examination results

    All lab results

    Demographic data

    DOB, sex, weight, age, race, height

    Concomitant meds

    Patient ID number

    Study number

    Drug dispensing information

    Informed consent

    IRB approval

    Visit dates

    Concurrent illness

    Source Data

    Source documents

    Hospital Records

    Clinic and office charts

    Laboratory reports


    Subject diaries

    Pharmacy dispensing records

    X-rays, CT scans, MRIs

    Case report forms when data is entered directly

    Magnetic media

    Photographic negatives

    Source Documents


    Additional inspectional activities/areas of concern:

    • Compare investigator’s version of the protocol to the version submitted by the sponsor to FDA

    • Check the integrity of the randomization process

    • Observe and note reasons for protocol violations

    • Note reporting of serious adverse experiences, including time frames

    • Observe evidence of unreported interim analyses

    • Note correspondence/telecons between clinical investigator and the IRB, monitor, and sponsor, referring physicians, and consultants

    What is generated after an inspection
    What is Generated After an Inspection

    FDA Form 483: Inspectional observations

    Left with CI at close of inspection

    Immediately available via FOI

    Establishment Inspection Report (EIR)

    Prepared by field investigator after inspection

    Includes exhibits supporting observed deficiencies

    Supervisory endorsement from District Office

    Brief summary statement

    Field recommendations

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