Knowledge Flashcards
6 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Knowledge flashcards as text
What is the difference between an IND and an NDA?
Answer: An IND allows clinical testing while an NDA requests marketing approval
An IND allows a sponsor to begin clinical trials, while an NDA requests FDA approval to market the drug.
What are inclusion and exclusion criteria in a clinical trial?
Answer: Characteristics that participants must have (inclusion) or must not have (exclusion) to enroll
Inclusion criteria define characteristics participants must have; exclusion criteria define characteristics that disqualify them.
What is informed consent in clinical research?
Answer: An ongoing process of providing information and ensuring voluntary participation throughout the study
Informed consent is an ongoing process, not just a signed document, involving comprehensive information and voluntary, informed decision-making throughout the trial.
What is the Common Technical Document (CTD) format?
Answer: A standardized format for regulatory submissions organized into five modules
The CTD is an internationally agreed-upon format for regulatory submissions organized into five modules.
What is the role of the sponsor in a clinical trial?
Answer: To initiate, manage, and finance the clinical trial
The sponsor takes responsibility for initiating, managing, and/or financing a clinical trial.
What are the phases of drug development from preclinical through post-marketing?
Answer: Preclinical, Phase I, Phase II, Phase III, and Phase IV (post-marketing)
Drug development progresses from preclinical testing through Phase I (safety), Phase II (efficacy/dosing), Phase III (confirmatory), review, and Phase IV (post-marketing).