ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
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This presentation will provide the detail of ICH-GCP E6 and their differences to Indian GCP and Shedule Y.
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ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
- 1. Good Clinical Practices (GCP) DR. RANJEET PRASAD (MPH,MBA,CCRP,BDS)
- 13. ICH-GCP-Section 3 Institutional Review Boards/ Independent Ethics Committee
- 19. ICH-GCP: Section 4 Investigator
- 34. ICH-GCP: Section 5 Sponsor Responsibilities
- 58. ICH-GCP: Section 7 Informed Consent
- 69. Differences and similarities between ICH-GCP and Indian GCP
- 72. GCP - A Shared Responsibility Sponsor Investigator Regulatory Authority Ethics Committee
- 73. Performance Skills Knowledge What to Why to Want to How to GCP IMPLEMENTATION
- 76. 122-A : Application for permission to import new drug 122-B : Application for approval to manufacture new drug 122-D: Permission to import or manufacture FDC 122-DA : Permission to conduct clinical trials for New Drug / Investigational New Drug 122-DAA : Clinical trial 122-E:New drug
- 77. List of Appendices For Schedule Y
- 78. Appendix X Contents Of The Proposed Protocol For Conducting Clinical Trials Appendix IX Stability Testing Of New Drugs Appendix VIII Ethics Committee Appendix VII Undertaking by the Investigator Appendix VI Fixed Dose Combinations (Fdcs) Appendix V Informed Consent Appendix IV Animal pharmacology Appendix III Animal toxicology (non-clinical toxicity studies) Appendix II Structure, contents & format for clinical study reports Appendix I-A Data required to be submitted by an applicant for grant of permission to import &/or manufacture a new drug already approved in the country. Appendix I Data to be submitted along with the application to conduct clinical trials / import / manufacture of new drugs for marketing in the country. Appendix XI Data Elements For Reporting Serious Adverse Events Occurring In A Clinical Trial . Appendix III Animal toxicology (non-clinical toxicity studies ) Appendix II Structure, contents & format for clinical study reports
- 87. Key Players in Clinical Research and their checklists
- 97. Happy Reading
Notas del editor
- The violation of human rights in clinical research was revealed most vividly in the experiments done by Nazi doctors on the inmates of concentration camps during World War II. To avoid such incidents, the Nuremberg Code was adopted in 1947. Based on it, the World Medical Association adopted the Declaration of Helsinki in 1964. It has been amended five times since then, most recently in 2001 at Edinburgh. It now forms the basis of various GCP guidelines. Since 1980 the pharmaceutical industry felt the need to have uniform ethical and scientific standards for clinical trials across the countries. Therefore, it took the lead to form the International Conference on Harmonization (ICH) for this purpose. The ICH had representatives of regulatory agencies and pharmaceutical industry from the USA, EU and Japan. They also invited contributions from Canada, Australia, the Nordic countries and the WHO. Their efforts culminated in the formulation and adoption of ICH GCP guidelines in 1996. Soon after, in 2000, the Indian Council of Medical Research (ICMR) released Ethical Guidelines for Biomedical Research in Human Subjects. These were followed, in 2001, by GCP Guidelines for Clinical Trials of Pharmaceutical Products In India from the CDSCO. These are the standards that clinical research workers in India have to follow now. If the research is international, then they also need to follow the ICH guidelines.
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- Clinical research, especially the trials of drugs, devices and diagnostics, involve four players who need to know, understand and follow GCP. They are: Investigator sponsor regulatory agency ethics committee During today and tomorrow, various experts will unfold before you the nuances of the various aspects of GCP. Therefore, I shall present the checklists that these players need to keep handy as ready reminders. These can help avoid common pitfalls in clinical research that lead to deviations from GCP.
- An investigator needs to ask himself: Am I interested in this research? Do I have the necessary expertise, time and facilities? Do I find the protocol scientifically and ethically sound? Is the patient information concise, complete and readable? Is the ICF properly written? Am I free to publish the results even if they are unfavorable to the sponsor? Can I defend the proposal to the ethics committee? Can I know the concerns of the committee in advance so that I can have a chance to resolve them with the sponsor beforehand? Am I willing to follow the conditions laid down by the ethics committee while approving my proposal?
- How shall I organize, brief and supervise my team for this research? How shall I facilitate the practice of informed consent? How shall I ensure accurate transcription of data from the patient’s file to his CRF before signing it? What precautions shall I take to ensure that serious adverse events are recorded, reported and followed up properly and in time? How will I schedule effective interaction with the sponsor’s monitor? What is my institution’s policy about direct access to patient files? How will I reconcile it with the protocol requirements? Do I have the facilities to archive source documents? What is my institution’s policy? Am I willing to go through the final report draft, verify the accuracy of data and conclusions, and amend it if necessary before approval? Am I willing to prepare for an audit from the sponsor or an inspection from the regulatory agency?
- A sponsor needs to consider: Can I justify the protocol, patient information and consent form to investigators on scientific, ethical and regulatory grounds? Does the investigator have necessary qualifications, training and experience, besides time and interest? Do I have necessary regulatory approval, and does the investigator have ethics committee approval? Am I willing to have the results published even if they are unfavorable? Have I ensured the quality of trial supplies? Have I arranged for proper initiation, monitoring and auditing of the trial?
- What arrangements have I made for data management and analysis? Have I provided for the drafting of study report? Am I willing to prepare the investigator for a regulatory inspection? Am I willing to archive the source documents if the investigator is unable to do so?
- Are the trials I am asking for really necessary? Do the current regulations need a review from scientific and ethical angles? Can I offer advance consultation to sponsors on acceptable efficacy and safety criteria, comparator product to be used, and relevance of the protocol to the proposed claim? Can I have open advisory panel meetings for reviewing applications and making decisions? How can I make inspections of investigational centers purposeful and instructive?
- The ethics committee need to ponder: Is there a need for this study? Will it produce useful information? Is the number of subjects justified? Is the choice of healthy volunteers or patients appropriate? Are they vulnerable persons?
- If current treatment to be withdrawn, is it justified? Will it pose any risk to the patients? Is placebo to be used for comparison? Is its use justified and safe? Are the doses and routes of administration justifiable? Is the nature and frequency of assessment appropriate? Is any invasive procedure to be done? What is its justification and what safety precautions have been proposed? If assessments involve drawing of blood, is the total volume justifiable and safe?
- Is patient information concise, complete and understandable? Are risks and benefits adequately and properly explained? Is compensation or other payment appropriate and adequate? Is there an insurance cover for study-related injury? Is the nature of treatment after study explained? Does the study require regulatory approval? If yes, has it been obtained by the sponsor?