CITI TRAINING EXAM 150 QUESTIONS WITH VERIFIED
AND UPDATED CORRECT SOLUTIONS/A+ GRADE/2023-
2024 VERSION
What must you file before conducting human
... [Show More] 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
Determine the trial phase:
CITI TRAINING EXAM 150 QUESTIONS WITH VERIFIED
AND UPDATED CORRECT SOLUTIONS/A+ GRADE/2023-
2024 VERSION
- Determine drug's effectiveness (primary goal)
- Determine long-term drug safety
- Confirm findings - correct answer Phase III
Determine the trial phase:
- Determine drug's short-term risk (safety) (primary goal)
- Examine preliminary effectiveness of drug - correct answer Phase II
Determine the trial phase from the subject population:
Controlled studies enrolling limited numbers of patients - correct answer Phase II
Determine the trial phase from the subject population:
Controlled and uncontrolled studies (but typically placebo-controlled and doubleblinded) enrolling larger patient numbers. - correct answer Phase III
Determine the trial phase from the subject population:
Normal healthy volunteers unless toxicity prevents exposure (e.g, cancer drugs). In this,
case patients with end-stage disease might be enrolled. - correct answer Phase I
If an IND application is submitted and the FDA has not contacted the physician within
30 days after acknowledging receipt, can the trial start? - correct answer Yes, one of
two conditions must be met.
1. 30 days elapsed since FDA received IND application and no hold as been placed.
2. Correspondence has ben received from FDA allowing the trial to start. [Show Less]