Quality assurance is the responsibility of the sponsor to ensure clinical trials are conducted properly according to regulations. It involves implementing quality control systems and allowing audits and inspections. Audits independently check that the study, data, patient safety, and regulatory compliance are accurate. Inspections allow regulatory authorities to review documents, facilities, and records. Proper preparation is key, such as having all required documents organized and understanding the protocol. Mistakes are common but can be prevented by understanding good clinical practice principles and having open communication.

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 ????????????