Audit conduct and report
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This document provides guidelines for conducting and reporting QA audits. It defines key terms like QA, audits and GCP. It outlines the responsibilities of the QA unit and clinical team in audits. The procedures section describes selecting projects for audit, preparing an audit plan, conducting the audit including opening/closing interviews, reporting findings according to severity, responding to audits with corrective actions, and closing the audit after satisfactory responses. The overall purpose is to ensure trials are conducted and data recorded/reported in compliance with GCP and regulations.
![Definition
•Good Clinical Practice • that provides assurance
(GCP)
• that the data and reported
•A standard for results are
•design, conduct, • credible and accurate
•performance, monitoring, • and that the rights, integrity
•auditing, recording, and confidentiality of trial
subjects are protected.
•analyses and reporting of
clinical trials
[1.24, ICH – GCP, E6]
3](https://image.slidesharecdn.com/auditconductandreport-121004055234-phpapp02/85/Audit-conduct-and-report-3-320.jpg)
![Definition
•Quality Assurance (QA):
All those
planned and systematic actions
that are established to ensure that
the trial is performed and
the data are generated, documented (recorded), and
reported in compliance with
GCP and the applicable regulatory requirement (s).
[1.46, ICH-GCP, E6]
4](https://image.slidesharecdn.com/auditconductandreport-121004055234-phpapp02/85/Audit-conduct-and-report-4-320.jpg)
![Definition
• Audit :
A systematic and independent examination of trial
related activities and documents to determine whether
the evaluated trial-related activities were
conducted ,
and the data were recorded ,
analyzed and accurately reported ,
according to the protocol, sponsor’s SOP, GCP and
the applicable regulatory requirement (s).
[1. 6, ICH- GCP E6]
5](https://image.slidesharecdn.com/auditconductandreport-121004055234-phpapp02/85/Audit-conduct-and-report-5-320.jpg)
![Procedures
Audit Closure
Should be after receiving the satisfactory responses
Auditor will enter the same in QA audit log
Audit Certificate should be issued by the Auditor
[5.19.3, ICH-GCP,E6]
15](https://image.slidesharecdn.com/auditconductandreport-121004055234-phpapp02/85/Audit-conduct-and-report-15-320.jpg)
Audit conduct and report
- 1. Conducting and Reporting QA audits Literature survey Ashish Kumar Awadhiya Quality Assurance and Training
- 2. Table of Contents Definitions Role of QA personals Guidelines for conducting and reporting QA audits References 2
- 3. Definition •Good Clinical Practice • that provides assurance (GCP) • that the data and reported •A standard for results are •design, conduct, • credible and accurate •performance, monitoring, • and that the rights, integrity •auditing, recording, and confidentiality of trial subjects are protected. •analyses and reporting of clinical trials [1.24, ICH – GCP, E6] 3
- 4. Definition •Quality Assurance (QA): All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement (s). [1.46, ICH-GCP, E6] 4
- 5. Definition • Audit : A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial-related activities were conducted , and the data were recorded , analyzed and accurately reported , according to the protocol, sponsor’s SOP, GCP and the applicable regulatory requirement (s). [1. 6, ICH- GCP E6] 5
- 6. Role of QA Preparation and review of SOPs To act as a moderator for quality improvement To provide advice on GCP matters To train the clinical research staff To confirm GCP and applicable regulatory compliance To plan and conduct audits 6
- 7. Guidelines for conducting and reporting QA audits Purpose Responsibilities Procedures 7
- 8. Purpose To define the procedures and operations for conducting and reporting the Quality Assurance Audits Includes procedures and activities about conduct and report the audits 8
- 9. Responsibilities Quality Assurance Unit / Auditor Plans, communicates and conducts the audits Propose corrective action plan if applicable Project / Clinical Team Ensures that documents and resources required to perform audits are provided. Ensures that corrective / preventive actions are taken place and gives written communication for the same (Audit Response) 9
- 10. Procedures Project selection Audit Plan Back ground information to prepare audit tools Audit plan preparation (audit objectives, scope of assessment, methodology, time frames) Review of audit plan with Project head and finally sign off by QA Head. Intimation of audits to all concerned persons Filing of audit plan If amended, should be intimated the same 10
- 11. Procedures Conducting Audits Shall be conducted as per audit plan and applicable SOPs Should include opening interview with key personals to clear the objectives of the audit, current procedures, review of relevant documents. Should end with closing interview to discuss the observation and mutual agreement on the same 11
- 12. Procedures Reporting Audit Findings Should be based on defined grading : Minor, Major and Critical Special attention to Major and Critical findings: time frame and level of intimation. 12
- 13. Procedures Reporting Audit Findings Should be clear, consistent and appropriate Should be accurately arranged according to severity. Should be approved by Head QA or designee Should be distributed within time frame to respective persons with confidentiality Significant misconduct and fraud should be reported separately up to the Higher Management Post compliance audit can be planned in necessary 13
- 14. Procedures Responding to Audits Should be within time frame Should have corrective action plan If possible provide the proof for the action planned and executed Written confirmation is necessary for critical/major findings Should resolve all the queries to close the audit 14
- 15. Procedures Audit Closure Should be after receiving the satisfactory responses Auditor will enter the same in QA audit log Audit Certificate should be issued by the Auditor [5.19.3, ICH-GCP,E6] 15
- 16. References ICH – GCP E6 16
- 17. Thank You!