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CITI Training | Questions & Verified Answers
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CITI Training | Questions & Verified AnswersWhat must you file before conducting human clinical trials with an
experimental drug? Correct Ans - IND application (Form FDA 1571)
During the clinical development phase of the IND process, what must
sponsors do? Correct Ans - 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 Ans - Form FDA 1572
What is the timeline of drug development? Correct Ans - Preclinical
trials, IND Submission,
Clinical Development (Phase I-III), NDA submission,
Marketing (Phase IV)
When does a sponsor submit the IND? Correct Ans - Prior to clinical
development phases (human trials). *30 day process.
What is the NDA? Correct Ans - New Drug Application, submitted prior
to Phase IV marketing phase.
How long does the NDA submission take? Correct Ans - 6 months - 2
years.
What is determined for a drug in the preclinical phase Correct Ans -
Pharmacokinetics and bioavailability Outcome shows promise of safety and
efficacy warranting additional studying.
How long does FDA have to review IND submission? Correct Ans - 30
days
,How long is the clinical development phase (Phase 1-III) in process for IND?
Correct Ans - 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
Ans - Phase I
Determine the trial phase:
- Determine drug's effectiveness (primary goal)
- Determine long-term drug safety
- Confirm findings Correct Ans - Phase III
Determine the trial phase:
- Determine drug's short-term risk (safety) (primary goal)
- Examine preliminary effectiveness of drug Correct Ans - Phase II
Determine the trial phase from the subject population:
Controlled studies enrolling limited numbers of patients Correct Ans -
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 Ans - 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 Ans - 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
Ans - 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 Ans - Protocol and Investigator's Brochure
What regulation must a PI comply with in order to use an edc system for a
clinical trial? Correct Ans - 21 CFR Part 11
21 CFR 56.115(b) Correct Ans -
21 CFR 312.57 Correct Ans -
21 CFR 312.62 Correct Ans -
21 CFR 812.140 Correct Ans -
What happened because of the concern and confusion regarding
interpretation of Part 11in 2003. Correct Ans - 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"
Development of most new drugs from discovery to marketing approval
usually takes: Correct Ans - 9 years or more
The first randomized, controlled study of an experimental drug versus aspirin
for postoperative pain control will enroll 55 patients in each arm. Which of the
following best describes the clinical phase of this study? Correct Ans -
Phase 2
Adults with more than a 12-month history of migraines were assigned
randomly in a double-blinded study to receive treatment with experimental
drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the
reduction in severity of the migraine attacks. Enrollment was 1200 subjects.
Which of the following best describes the clinical phase of this study?
Correct Ans - Phase 3
Long-term toxicology of an experimental drug in animals most likely refers to
which part of drug development? Correct Ans - Preclinical
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