CFR 21 PART 50 and Part 54 Presentation.pptx

21 CFR Part 50 and 54 are U.S. Food and Drug Administration (FDA) regulations for clinical trials. 21 CFR Part 50 focuses on the protection of human subjects, particularly informed consent, and establishes rules for the ethical treatment of participants in research. 21 CFR Part 54 mandates the financial disclosure by clinical investigators to ensure financial interests do not improperly influence the conduct or results of a clinical trial.

1. CFR 21 PART 50: PROTECTION OF HUMAN SUBJECTS CFR 21 PART 54: FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS Aaditi K. Kamble. Assistant professor DRUG REGULATORY Affairs department 1

2. CONTENTS Sr. No. Contents Page No. I. Introduction 3 II. CFR 21 Part 50:Protection of Human Subjects 1. Subpart A-General Provisions 4 2. Subpart B-Informed Consent of Human Subjects 5 III. CFR 21 Part 54:Financial Disclosure by Clinical Investigator 1. Purpose 7 2. Definitions 8 3. Certification and Disclosure Requirements 9 4. Agency Evaluation of Financial Interests 10 5. Recordkeeping and Record Retention 11 6. References 12 2

3. INTRODUCTION CFR 21 Part 50 applies to all clinical investigations regulated by the FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act. CFR 21 Part 54 applies to any applicant who submits a marketing application for human drug, biological product, or device and who submits covered clinical studies. 3

4. CFR 21 Part 50: Protection of Human Subjects Subpart A: General Provisions Legally Authorized Representative: An authorized individual by law to consent on behalf of the subject to the subject's participation in the research. Assent: Means a child’s affirmative agreement to participate in a clinical investigation Test article: Any drug ,medical device for human use, human food, color additive, electronic product, or any other article. 4 Definitions :

5. Subpart B:Informed Consent of Human Subjects 1. General Requirements For Informed Consent: Provide sufficient opportunity to subject to consider his/her participation without any influence Information given to the subject shall be in unambiguous language 2. Exception from General Requirements: Subject confronted by a life-threatening situation necessitating use of test article Inability to communicate with subject Insufficient time to obtain consent from subject’s legal representative 5

6. 3. Basic Elements of Informed Consent: A statement explaining Purpose of research Expected duration of subject’s participation Procedure description Possible risks or discomfort to the subject 4. Documentation of Informed Consent: Documented using a written consent form approved by IRB, signed and dated by subject or legal representative at the time of consent Written consent document containing elements of IC 6

7. CFR 21 Part 54:Financial Disclosure By Clinical Investigators Purpose: The FDA evaluates clinical studies, for new human drugs and biological products and marketing applications. The data generated is reviewed to determine whether the applications are approvable under the statutory requirements. 7

8. Definitions: Clinical Investigator: only an identified investigator involved in the treatment or evaluation of research subjects Covered clinical study: study of a drug or device in humans submitted in a marketing application, that the applicant or FDA relies on to establish that the product is effective 8

9. Certification and Disclosure Requirements: Submission of a list of all clinical investigators to determine if the product meets FDA’s requirements Complete disclosure of financial interests of clinical investigator An applicant shall submit, for each investigator, either a certification or a disclosure statement 9

10. Agency Evaluation Of Financial Interests: Evaluation of disclosure statement: Impact determination of any financial interests on reliability of study Effect of study design: Design and purpose of study Agency actions to ensure data reliability: 1. Initiating agency audits 2. Requesting that the applicant submit further analyses of data 3. Conducting additional independent studies to confirm the results 10

11. Recordkeeping and Record Retention: Financial records of clinical investigators to be retained 1. Records of any financial interest paid to clinical investigators by the sponsor 2. Records showing significant payments of other sorts, made by sponsor to clinical investigator Requirements for maintenance of clinical investigators’ financial records 1. Retention of records for 2 years after date of approval of the application 2. Access to and copy, verification of the records 11

12. Reference Part 50-CFR-Code of Federal Regulations Title 21, Volume 1, Revised as of April 1, 2018 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1 Part 54-CFR-Code of Federal Regulations Title 21, Volume 1, Revised as of April 1, 2018 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1 12

13. THANK YOU 13