GCP Guidelines: By RxVichuZ!! :)
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The document outlines the international quality standards for Good Clinical Practice (GCP) in clinical trials, emphasizing ethical guidelines, trial design, conduct, and monitoring. It specifies the importance of ensuring the safety and well-being of trial subjects, obtaining informed consent, and maintaining confidentiality and data integrity. Additionally, it highlights compliance with protocols and regulatory requirements throughout the trial process.
![1. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products_Guide
lines/Efficacy/E6/6_R1_Guideline.pdf
2. Malaysian Guidelines for Good Clinical Practice. 2nd edition.
Ministry of Health Malaysia; 2004.
3. Otte E, et al. Good Clinical Practice: Historical background and key
aspects. 2005;26:563-74[PubMed].](https://image.slidesharecdn.com/gcpguidelines-180425141030/85/GCP-Guidelines-By-RxVichuZ-10-320.jpg)
GCP Guidelines: By RxVichuZ!! :)
- 2. International quality standard, provided by ICH GCP enforces tight guidelines on ethical aspects of a clinical study Provides standards for the following aspects of a clinical trial: a. Design b. Conduct c. Performance monitoring d. Auditing e. Recording f. Analysis g. Reporting.
- 3. GCP guidelines provide assurance that: a. Data & results are credible & accurate b. Rights, integrity & confidentiality of trial subjects are maintained c. Newly developed compounds are safe & efficacious.
- 4. A. 2.1 : - Clinical trials should be conducted in accordance with ethical principles (as elucidated in Declaration of Helsinki) - Trials should be conducted in harmony with GCP & other applicable regulatory requirements. B. 2.2 : - Before a trial is initiated, focus on risk vs benefit ratio - Foreseeable risks & subject inconveniences should be weighed against anticipated benefits for the trial subject & society. - Trial should be initiated & continued only if anticipated benefits outweigh risks.
- 5. C. 2.3: - Consider the following aspects of trial subjects as paramount, which should prevail over interests of science & society: a. Rights b. Safety c. Well-being. D. 2.4: - Existing/ available non-clinical & clinical informations with respect to an investigational product sufficient enough to conduct the proposed clinical trial.
- 6. E. 2.5: - Clinical trials should be : a. Scientifically sound b. Described in a clear, detailed protocol. F. 2.6: - Trial should be conducted in compliance with the protocol, that has been approved by IRB/IEC.
- 7. G. 2.7: - A qualified physician responsible for the following aspects of trial subjects: a. Medical care b. Medical decisions made on behalf of the trial subjects. H. 2.8: - Each individual conducting the clinical trial should be qualified by education, training & experience, in order to perform his/her respective tasks.
- 8. I. 2.9: - Freely given informed consent should be obtained from every subject prior to clinical trial participation. J. 2.10: - All clinical trial information should be recorded, handled & stored in a way, such that it can help in accurate reporting, interpretation & verification. K. 2.11: - Confidentiality of records (that help in subject identification) should be protected, in accordance to applicable regulatory requirements.
- 9. L. 2.12: - Investigational products should be manufactured, handled & stored, in accordance with applicable GMP guidelines. - Investigational products should be used in accordance with approved protocol. M. 2.13: - Systems with procedures that assure quality of every aspect of the trial should be implemented.
- 10. 1. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products_Guide lines/Efficacy/E6/6_R1_Guideline.pdf 2. Malaysian Guidelines for Good Clinical Practice. 2nd edition. Ministry of Health Malaysia; 2004. 3. Otte E, et al. Good Clinical Practice: Historical background and key aspects. 2005;26:563-74[PubMed].
- 11. THANK YOU!!!