CITI Training Exam Questions with Correct Answers

What must you file before conducting human clinical trials with an experimental drug? Correct Answer IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND. Correct Answer Form FDA 1572 What is the timeline of drug development? Correct Answer Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer New Drug Application, submitted prior to Phase IV marketing phase. How long does the NDA submission take? Correct Answer 6 months - 2 years. What is determined for a drug in the preclinical phase Correct Answer Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying. How long does FDA have to review IND submission? Correct Answer 30 days How long is the clinical development phase (Phase 1-III) in process for IND? Correct Answer 6-7 years. Determine the trial phase: - Assess toxicity - Determine drug's PK and PD profiles - Determine doses resulting in sufficient biological level of drug Correct Answer Phase I