Quality Assurance : Audit And Inspection
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  • 1. Quality Assurance : Audit & Inspection Prashanth Babu. M Principal Consultant
  • 2. Topics to be discussed
    • Why do we need quality assurance ?
    • Who should be involved in the QA process ?
    • Audit & Inspection
    • How to prepare for an audit ?
  • 3. Quality Assurance is mentioned in ICH-GCP
    • Chapter 5 : Sponsor
    • Section 5.1 Quality assurance & quality control
    • ‘ The sponsor is responsible for implementing & maintaining quality assurance & quality control systems with written SOPs to ensure that trials are conducted & data are generated , documented (recorded) in compliance with protocol , GCP & applicable regulatory requirement(s)
    ICH GCP 1997
  • 4. Quality Assurance is responsibility of sponsor
    • ‘ The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites , source data/ documents & reports for the purpose of monitoring & auditing by the sponsor & inspection by domestic & foreign regulatory authorities’
    ICH GCP 1997
  • 5. Who should be involved in QA process Quality of the study Investigators/ team Sponsor Ethics Committee Institution Health Authority Monitor/ study operation team Biometrics team Patients QA team
  • 6. The Quality Assurance Procedure ?
    • Audit
    • The i ndependent, systematic action to ensure the quality of study, data generated, is accurate, reliable, patient’s safety and right is protected and followed GCP, SOPs & applicable regulations in the country
    ICH-GCP 1997
  • 7. Inspection
    • The act by a regulatory authority(ies) of conducting an official review of documents , facilities , records and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial , at the sponsor’s and/ or CRO’s facilities or at other establishments deemed appropriate by the regulatory authority(ies)
    • ICH-GCP 1997
  • 8. Why do the authority inspect ?
    • Support regulatory authority decision
    • Base upon
      • Safety
      • Validity of data
      • Regulatory compliance
      • Subject’s right protection
      • Law enforcement
    • When the data from the trial will be used for authority approval
  • 9. How to Prepare for Audit
  • 10. What are the areas concerned by auditor
    • Patient’s safety
    • Has the study approved
    • Did patient agree to join the study
    • Does the investigator follow protocol
    • Does the investigator report the adverse event (on time)
    • Does Ethics Committee be informed on safety
    • Does the patient be informed on new information
    • Study credibility
    • Does the patient exist
    • How can we ensure that the procedure is followed
    • Human, machine variation
    • We have to document all the activity
    • Does the facilities meet the standard
    • How can we ensure the equipment work properly
  • 11. Preparation for Audit
    • Should start from the beginning of the study
    • Ensure that we have the documents to prove that study has been conducted properly
      • According to ICH-GCP, Local regulation, Institution SOP
    • All party understand the protocol, procedure
    • Any concern raised by any party should be documented
    • Aware of the chronology of the event, version of documents
  • 12. Essential Documents (1)
    • Study protocol, patient information sheet, informed consent, questionnaire, investigator brochure etc.
      • Version, date submitted, approved, implemented
    • Safety report : AE, SAE, SUSAR
      • Submitted to EC, FDA
    • Agreements : clinical, financial
    • Study personnel : CV, authorised letter, sample of signature
    • Enrollment log
    • Correspondence
  • 13. Essential Documents (II)
    • Case record form : CRF
      • Signed & dated informed consent
      • Completeness of CRF
      • Investigator signed & dated in the assigned pages
      • Accuracy of data compared with source data
      • Black ball point pen
      • Logical date according to protocol !
      • Source data has to be available
  • 14. Essential Documents (III)
    • Source data
      • Patient note (OPD card) : should document the information required by the protocol (monitor can prepare the check list page & attach to the OPD card)
      • Other documents : lab test, ECG, X-rays, CT scan,
      • Translator is required in case local language is not English (FDA inspection might ask for an independent translator)
  • 15. Essential Documents (IV)
    • Standardisation, maintenance of equipment
      • Document to prove that all procedure is followed
    • Logistics, accountability of the test kits, study medication
      • Temperature controlled required
    • Study personnel who operate the machine
      • Well trained; training record, CV
    • Sample handling procedure
      • Tissue block, blood, serum, etc
  • 16. Major Mistakes
    • Misconduct of the study
      • Study not being approved
      • Major protocol violation
      • Patient safety : SAE
      • Fraud data
    • Cause loss of reputation of investigator/ institute
    • Loss of reputation of sponsor
    • Withdrawal, termination of product license
  • 17. Problems/ Mistakes
    • Things to be remembered
    • Problems/ mistakes are common things
    • Auditor’s job is to find mistake !
    • Don’t arrange or make up, he/she will find anyway
    • Too good to be true when everything is perfect
    • As long as the mistake is minor & acceptable
  • 18. What needs to be done to prevent mistake
    • Understands the principle of GCP
      • Patient safety
      • Data validity
    • Proactive approach
      • Foresee the problems might happen
    • Good communication with monitor
      • Inform monitor if there is anything unclear
    • Positive attitude
      • Mistake does happen, nothing to hide
  • 19. Summary
    • QA is the key responsibility of sponsor
    • QA involved all parties in the clinical study
    • QA should be started from the beginning of the study (planning process)
    • QA should be placed in every step of the study
    • Standard should be defined & comply to GCP/ regulation
    • QA can not be achieved without the cooperation of all parties
  • 20. Thank you for your attention
    • Any questions ????????????