Quality Assurance : Audit And Inspection


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Quality Assurance : Audit And Inspection

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