CITI Training Test Prep | 134 Questions with 100% Correct Answers
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CITI
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Kaplan University
What must you file before conducting human clinical trials with an experimental drug? - IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: ...
citi training test prep | 134 questions with 100 correct answers
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CITI Training Test Prep | 134 Questions
with 100% 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
Determine the trial phase:
- 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 double-blinded)
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.
What must be provided to investigators before they beginning conducting trials at their site?
Correct Answer: Protocol and Investigator's Brochure
What regulation must a PI comply with in order to use an edc system for a clinical trial? Correct
Answer: 21 CFR Part 11
21 CFR 56.115(b) Correct Answer:
21 CFR 312.57 Correct Answer:
21 CFR 312.62 Correct Answer:
21 CFR 812.140 Correct Answer:
What happened because of the concern and confusion regarding interpretation of Part 11in 2003.
Correct Answer: FDA withdrew all the guidance documents related to Part 11, while re-
examining.
They then issued: Guidance for Industry: Part 11, Electronic Records; Electronic Signatures-
Scope and Application (2003) and Guidance for Industry: Computerized Systems Used in
Clinical Investigations (2007). ** The 2007 guidance "supplements the 2003 guidance"
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