regulatory perspectives of clinical trails

Good Clinical Practice
Principle of ICH GCP
Institutional Review Board (IRB)/IEC
Informed Consent

1. Submitted by: Pankaj Kumar Maurya M.Pharm ( Pharmacology) Roll No. 1888024002 Submitted to: Ms. Mandeep Kaur Assistant Professor Department O f Pharmacology REGULATORY PERSPECTIVES OF CLINICAL TRIALS CLINICAL RESEARCH AND PHARMACOVIGILANCE-MPL 204T SCHOOL OF PHARMACEUTICAL AND HEALTH CARE SCIENCES

2. Syllabus Introduction Principles of ICH GCP Institutional Review Board (IRB) Informed Consent Reference 2 /21 Contents

3. Module :-1 Regulatory Perspectives of Clinical Trials: Principles of International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines Ethical Committee: Institutional Review Board, Ethical Informed Consent Process: Structure and content of an Informed Consent 3 /21 Syllabus

4. 4 /21 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected. This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. Introduction

5. 5 /21 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety, and well-being of the trial subjects are the most important considerations. Principles of ICH GCP

6. 6 /21 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. Clinical trials should be scientifically sound, and described in a clear, detailed protocol. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/ favourable opinion. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. Principles of ICH GCP

7. 7 /21 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task. Freely given informed consent should be obtained from every subject prior to clinical trial participation. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement. Principles of ICH GCP

8. 8 /21 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP).They should be used in accordance with the approved protocol. Systems with procedures that assure the quality of every aspect of the trial should be implemented. Principles of ICH GCP

9. 9 /21 INSTITUTIONAL REVIEW BOARD OR INDEPENDENT ETHICS COMMITTEE

10. 10 /21 Responsibilities An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. The IRB/IEC should obtain the following documents: -Trial protocol -Written informed consent form -Subject recruitment procedures -Written information to be provided to subjects -Investigator's Brochure -Information about payments and compensation available to subject -Investigator’s current curriculum vitae and any other documents that the IRB/IEC may need to fulfill its responsibilities

11. 11 /21 Responsibilities The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following: -Approval/ favourable opinion -Modifications required prior to its approval/ favourable opinion -Disapproval / negative opinion -Termination/suspension of any prior approval/ favourable opinion The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.

12. 12 /21 Responsibilities The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject. The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.

13. 13 /21 INFORMED CONSENT

14. 14 /21 Informed consent The investigator should have the IRB/IEC's written approval/ favourable opinion of the written informed consent form and any other written information to be provided to subjects. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to continue participation in the trial. The communication of this information should be documented. Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial.

15. 15 /21 Informed consent None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence. The investigator should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.

16. 16 /21 Informed consent The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness. Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject's legally acceptable representative. If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion.

17. 17 /21 Informed consent Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following. -That the trial involves research The purpose of the trial The trial procedures to be followed, including all invasive procedures The subject's responsibilities The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus

18. 18 /21 Informed consent The alternative procedure or course of treatment that may be available to the subject, and their important potential benefits and risks The compensation and/or treatment available to the subject in the event of trial-related injury The anticipated prorated payment, if any, to the subject for participating in the trial The anticipated expenses, if any, to the subject for participating in the trial That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled

19. 19 /21 Informed consent That records identifying the subject will be kept confidential and will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential The expected duration of the subject's participation in the trial The approximate number of subjects involved in the trial

20. 20 /21 References Guideline, ICH Harmonised Tripartite. “Guideline for Good Clinical Practice E6 (R1) Current Step 4 version dated” 10 June 1996. Bhuiyan , P. S., and N. N. Rege . "ICH Harmonised Tripartite Guideline: guideline for good clinical practice." (2001). Guideline, ICH Harmonised Tripartite. "Guideline for good clinical practice." J Postgrad Med 47.3 (2001): 199-203.

21. 21 /21 Thank You