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					    WHAT TO EXPECT
     AND HOW TO
    HANDLE AN FDA
     INSPECTION!!!
Joseph X. Kaufman
Director of Quality Assurance
4460 Red Bank Expressway
Cincinnati, Ohio 45227
Phone: 513-721-3868
Learning Objectives!!!!

       Developing your strategy
       What happens during an FDA Inspection?
       Do’s & Don’ts with the FDA Investigator!
       What records will the FDA review?
       Training Files – Yours and its contents
       Common inspection deficiencies
       The inspection is over…Now what happens!

January 4, 2011                                    2
                     The FDA’s
           Bioresearch Monitoring Program
 A comprehensive, Agency-wide
  program of on-site inspections and
  data audits designed to monitor all
  aspects of the conduct and reporting
  of FDA-regulated research.
 Includes: IRBs/CROs/Clinical Sites/

  Academia/Sponsors/Hospitals

1/4/2011                                    3
               The FDA Motto


  “In      God we Trust; all others
           must show their data!!!”



1/4/2011                               4
The Purpose of an FDA Inspection

The purpose of the FDA Inspection is two
   fold:
  Protect the rights, safety, and welfare of
   human research subjects
  Declaration of Helsinki/Belmont Report
   and Nuremberg Code – Ethics Training
  Assure the quality and integrity of data
   collected.


1/4/2011                                        5
               FDA INSPECTION
INITIAL CONTACT BY FDA INVESTIGATOR

   Routine Inspection: Surveillance
    Inspection Notice 7-10 days by phone.
    Do not delay the inspection, accommodate a convenient
    time/date.

   For Cause Inspection: Just show up!!!
    A particular event or circumstance triggered
    the inspection. Consumer complaint.
    Data results are too good to be true.



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           Inspection References

 Compliance Program 7348.811….
Clinical Investigators - see link
http://www.fda.gov/ora/ftparea/compliance/48_
  811.pdf

These are the test questions!!!



1/4/2011                                        7
                     Documentation
      Compliance Program 7348.811, states:
•      See Part III – Page 5 – “Describes the Investigator’s
       Source Documents in terms of their legibility,
       organization, completeness”….
•      One item FDA-483, “Data cannot be evaluated in its
       current condition”.




    1/4/2011                                                   8
                      FDA Arrival

    FDA-482 - Notice of Inspection to most responsible
     individual. Principal Investigator/Sub-Investigator or
     Coordinator. Photo Identification, Credentials, Badge
     will be presented.
    Hand copy name, badge number/business card
    You are not permitted to photocopy credentials
    Typical inspection lasts 2-5 days.




1/4/2011                                                      9
FDA Investigator’s background
Who are you dealing with?
   Majority have at least a Bachelors in a scientific
    field…biology, chemistry, biochemistry, or
    closely related field.
   Training in FDA Law – Food, Drug and Cosmetic
    Act
   Training in Investigative Interviewing Techniques
   Training in a variety of subject fields- IRBs
    Clinical Studies, Contract Research
    Organizations, Phase I etc..


1/4/2011                                             10
                  Audit Procedures

   FDA Investigator is going to provide a reason for the
    inspection.
   Place them in a friendly work environment.
   This is the time where you want to discuss your
    schedule/meetings/availability of the PI.
   Ongoing discussion of inspection proceedings and
    findings; no surprises at conclusion. Ask the investigator
    for a time frame, schedule end of the day wrap up
    meetings.
   Collect records to substantiate observations/facts
   May collect sworn affidavits – FDA-463(a)


1/4/2011                                                     11
Previous work in hand!

           The FDA investigator has in her/his possession
            the following prior to visiting your site:
       1.   The previous inspection report if applicable.
       2.   List of adverse events/serious adverse events.
       3.   Copy of protocol
       4.   Example copy of Case Report Form or maybe,
            a subject case report form….if so, they are
            looking for something particular.




1/4/2011                                                 12
              Your Game Plan!

   Develop an SOP (Standard Operating
    Procedure) on how to handle FDA
    Inspections.
   Keep everyone under control.
   Who are the contact people?
   Those who cannot keep quiet or talk way too
    much – Quarantine these folks.



1/4/2011                                          13
                   The Do’s
    Do provide good directions and a meeting place
    Do offer a cup of coffee or beverage
     (No dinners/No breakfasts/No lunches/No gifts)
    Provide photocopying for the FDA Investigator!
      Make duplicates: Copy for the FDA and your
     site.
      Why? Helpful/Control/They’re not walking
     around
    Do dress in a professional manner.
1/4/2011                                         14
 The Don’ts with the FDA


     Do not be left alone with the FDA
      Investigator, be in pairs at all times.
     Do not feel a need to fill silence, be aware!
     Do not disappear for hours at a time.
      Check in every 40-45 minutes…you do not
      want them to assume if something is
      missing, you do not have it.

1/4/2011                                         15
 The Don’ts with the FDA-cont.
   Do not comment on other sites or
    competitors, Do not talk disrespectfully of
    co-workers or your superiors. No
    unnecessary talking by other employees.
   Do not make jokes about the FDA, or
    other government agencies. No politics.
   If you do not know an answer to a
    question, say so!



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                     Records Reviewed

          Records subject to review

1.         IRB correspondence
2.         Protocol
3.         Subject Case Report Forms
4.         Informed Consents
5.         Test Article Accountability Records (Drugs)
6.         Monitoring Visits
7.         Protocol Amendments
8.         Adverse Events/Serious Adverse Events

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                    Records Reviewed
  Protocol
          Investigational Plan
          Is it the same one provided by the sponsor and
           approved by the IRB?
          Have all protocol amendments and addendums
           been approved by the IRB?
          Is the most recent version being used?
          Is the protocol being followed?
          The FDA will ask for a copy of the latest revision.



1/4/2011                                                     18
               Subjects Reviewed

   Do not ask which subjects are going to be evaluated
    ahead of time! The FDA will not tell you.
   Typically, the normal inspection entails a review of
    the square root + 1 of subjects enrolled in the
    clinical study. 25 = 6
   The FDA Investigator is looking to find a pattern of
    deficiencies.




1/4/2011                                               19
           Case Report Forms
   Case Report Forms will be cross-checked
    with the source documents to confirm
    captured data, medical records, test results,
    physician progress notes, medical history and
    source documents contain the same data.
   Post it Notes




1/4/2011                                        20
                    Reporting

   Do not use white-out.
   When crossing out data, put initials/date and
    correct information.
   Note-To-File for obvious protocol violations or
    deviations, send to IRB and Sponsor….not
    just the sponsor.
   Notes-to-File do not absolve you from your
    error or mistakes.

1/4/2011                                          21
             Informed Consent

   Approved by the IRB? All revisions?
   Contained all required elements of
    informed consent, see 21 CFR 50.25
   Have the subjects signed informed
    consent prior to any study treatment or
    medical procedures? EKGs versus time
    on consents!


1/4/2011                                      22
                Informed Consent

   Add a statement to your source documents in this
    sort of fashion –
    “Informed Consent was obtained prior to initiation of
    any screening procedures or study related
    activities”.
   Explain the Informed Consent – Does subject truly
    realize the time, medication, schedules, needle
    sticks,EKGs, Single/Double Blind/Placebo?




1/4/2011                                                23
           COMMON DEFICIENCIES

 Informed Consents
   Failure to have subjects sign informed consent.
   Informed Consent fails to meet the required
    elements of informed consent per 21 CFR
    50.25.
   Failure to maintain original copy.
   FDA will check every subject’s informed
    consent.
   Informed Consent Dates
1/4/2011                                          24
           COMMON DEFICIENCIES

FDA-1572s:

   Sub-Investigators must be identified on the FDA-
    1572 prior to seeing subjects in the clinical study.
   FDA-1572s are the Principal Investigator’s
    document…they are the ones who sign the form.
    This document should be signed by PI and dated by
    PI. No pre-printed dates. Handwritten dates.
   Co-Investigators and Sub-Investigators are not
    the same term.

1/4/2011                                               25
           Co-Investigators/Sub-Investigators

   Co-Investigator is used when a study is conducted
    by more than one investigator, each of whom
    assumes equal responsibility for the conduct of the
    study and adherence to the regulations. Co-PIs are
    often used in drug studies when an investigator has
    multiple sites where a different investigator is
    responsible for each location.
   Sub-Investigator is any individual member of the
    clinical trial team designated and supervised by the
    Principal Investigator to perform trial related
    procedures.


1/4/2011                                                   26
                  Pregnancy

   Pregnancy is not considered a serious
    adverse event.
   Subject may be taken off study
    (IRB/Sponsor/PI).
   Multiple subject pregnancies – Does the
    informed consent explain acceptable means
    of birth control?
   Subject must be followed until birth of
    baby….status and health of child at birth
    must be reported to Sponsor/IRB.
1/4/2011                                        27
       Test Article Accountability Records

   Records of receipt…UPS, FED-EX
   If subject loses a pill or forgets medication, record in
    source documents/progress notes.
   When monitor packages drug for return shipment,
    be present to verify count.
   Pharmacy – FDA will visit the pharmacy if drug
    dispensing occurs by Pharmacist.




1/4/2011                                                   28
SUBJECTS LOST TO
FOLLOW-UP

   Document in subject’s progress notes
    attempts to contact subject via phone or e-
    mail. Record date/time message left or sent
   Send registered letter, keep copy of letter or
    postal receipt….most favored.
   Three attempts is due diligence.



1/4/2011                                             29
                   TRAINING FILES

Contents
          Job Description
          Resume/Curriculum Vitae updated once a year.
          Licenses/Certifications
          Standard Operating Procedure Training
          Continuing Education (GCP Training).
          Ethics – Belmont Report/Declaration of
           Helsinki/Nuremberg Code



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                SIGNATURES

   There is never an instance or situation during
    an inspection of a clinical investigator in
    which anyone at the site would be required to
    sign any FDA Document.
   You do not sign the FDA-482, FDA-483 or
    FDA-463(a)




1/4/2011                                         31
                         AFFIDAVITS
    Affidavits, Form 463a
           If the FDA Investigator presents an affidavit, you
           do not read, listen to or sign the affidavit. If the
           FDA attempts to read this document to you,
           excuse yourself from the room.

           This is not a refusal. No matter what….
           you do not sign this document!




1/4/2011                                                          32
CLOSE-OUT DISCUSSION
   FDA Investigator will have a close-out meeting:
          FDA-483 Inspectional Observations
          Responding to FDA-483 Items
          Explain any special circumstances regarding
           observations
          Describe specific actions taken or planned that will
           correct and prevent future deviations
          If issued, respond verbally during the final discussion
           (FDA investigator will include response in EIR)
          Send a written response to District Office and Center
           contact
          You may opt to do both (most do)


1/4/2011                                                             33
             FDA INSPECTOR’S REPORT
Establishment Inspection Report (EIR)
   Prepared by the FDA investigator performing the
    inspection following every inspection
          Details inspection and findings
          Includes exhibits to document findings
   EIRs for BIMO inspections sent to CDER (Center for
    Drug Evaluation and Research) for review and final
    classification
   Assigning Center issues post-inspection
    correspondence and initiates follow-up actions
   Available through Freedom of Info Act

1/4/2011                                              34
           FOI – Freedom of Information

FDA's Electronic
 Freedom of Information

    Warning Letters and Responses
        http://www.fda.gov/foi/warning.htm




1/4/2011                                     35
Inspection Classification
EIR Inspection Classifications
       No Action Indicated (NAI)
          No objectionable conditions or practices

       Voluntary Action Indicated (VAI)
          Objectionable conditions or practices
          But not at threshold to take or recommend
           administrative or regulatory action

       Official Action Indicated (OAI)
          Serious objectionable conditions found
          Regulatory action recommended



1/4/2011                                               36
                   References


   Division of Bioresearch Monitoring
     www.fda.gov/cdrh/comp/bimo.html

   Application Integrity Policy List
     www.fda.gov/ora/compliance_ref/aiplist.html

   Disqualification List
     www.fda.gov/ora/compliance_ref/bimo/dis_res

      _assur.htm


1/4/2011                                        37
                  Disclaimer


   The contents of this presentation are my
    own, and do not necessarily reflect the
    views and/or policies of the Food and Drug
    Administration or its staff. The Food and
    Drug Administration will not be bound by
    any of the comments or information
    contained in this presentation.

1/4/2011                                     38

				
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