Lesson 3 question n answers graded A+ 2023/2024

Lesson 3Regulatory Project Manager (RPM) - correct answer Primary point of contact for communications between IND sponsors and FDA during the life cycle of drug development, The RPM is also the primary contact for facilitating the timely resolution of technical, scientific, and regulatory questions, conflicts, or communication challenges between the sponsor and the review team. FDA -suggested critical milestone meetings - correct answer .pre-IND, .end-of-phase 1 (EOP1), .end-of-phase 2 (EOP2), .pre-NDA/BLA meetings. Adverse Event (AE) - correct answer Any untoward medical occurrence in a subject taking part in a clinical trial. The AE does not necessarily have a causal relationship with the treatment Blinding/Masking - correct answer Single Blind = the subject is unaware Double Blind = both the subject and the investigator are unaware Data Safety Monitoring Board(DSMB) - correct answer An independent data monitoring committee established by sponsor to assess at intervals the progress of a clinical trial, the safety data, and efficacy of endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial Institutional Review Board - correct answer Independent body containing medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. A US term. IRB Obligations - correct answer .Ensure risks to subjects are minimized and reasonable in relation to anticipated benefits .Ensure patient selection is as equitable as possible relative to demographics and the clinical trial's purpose .Review of protocol, informed consent form (ICF), and Investigator's Brochure (IB)