ICH E6(R2) Good Clinical Practice verified to pass 2023/2024

ICH E6(R2) Good Clinical Practice- At least 5 members - At least one member whose primary area of interest is in a nonscientific area -At least one member who is independent of the institution/trial site - correct answer What are the minimum requirements for IRB? 3 years - correct answer The IRB/IEC should retain all relevant records (e.g. written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least ___ _________ after completion of the trial and make them available upon request from the regulatory authority(ies). Protocol and amendments ICF Advertisements for subjects recruitment Investigator's brochure Evidence of investigator's qualifications. - correct answer Name all five required documents for IRB review. D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs - correct answer In which of the following instances is it necessary to contact the IRB/IEC? A. Each time a new subject is enrolled B. If the investigator does not complete enrollment C. When a subject is found to be noncompliant with the trial medication D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs Impartial Witness - correct answer If the subject is unable to read or if a legally acceptable representative is unable to read, an _______________ should be present during the entire informed consent decision.