CITI training
1.What must you file before conducting human clinical trials with an exper- imental drug?: IND application (Form FDA 1571)
2.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:
safety updates
copies of new protocols FDA 1572
Annual Progress reports
3.this document notifies FDA of relevant changes in investigators conduct- ing clinical trials under the IND.: Form FDA 1572
4.What is the timeline of drug development?: Preclinical trials, IND Submis- sion,
Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV)
5.When does a sponsor submit the IND?: Prior to clinical development phases (human trials). *30 day process.
6.What is the NDA?: New Drug Application, submitted prior to Phase IV market- ing phase.
7.How long does the NDA submission take?: 6 months - 2 years.
8.What is determined for a drug in the preclinical phase: Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying.
9.How long does FDA have to review IND submission?: 30 days
10.How long is the clinical development phase (Phase 1-III) in process for IND?: 6-7 years.
11.Determine the trial phase:
-Assess toxicity
-Determine drug's PK and PD profiles
-Determine doses resulting in sufficient biological level of drug: Phase I
12.Determine the trial phase:
-Determine drug's effectiveness (primary goal) -Determine long-term drug safety
-Confirm findings: Phase III .Determine the trial phase:
-Determine drug's short-term risk (safety) (primary goal)
-Examine preliminary effectiveness of drug: Phase II
14.Determine the trial phase from the subject population: Controlled studies enrolling limited numbers of patients: Phase II
15.Determine the trial phase from the subject population:
Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers.: Phase III
16.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.: - Phase I
17.If an IND application is submitted and the FDA has not contacted the physician within 30 days after acknowledging receipt, can the trial start?: - 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.
18.What must be provided to investigators before they beginning conduct- ing trials at their site?: Protocol and Investigator's Brochure
19.What regulation must a PI comply with in order to use an edc system for a clinical trial?: 21 CFR Part 11
20. 21 CFR 56.115(b):
21. 21 CFR 312.57:
22. 21 CFR 312.62:
23. 21 CFR 812.140:
24.What happened because of the concern and confusion regarding inter-
pretation of Part 11in 2003.: 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: Comput- erized Systems Used in Clinical Investigations (2007). ** The 2007 guidance "supplements the 2003 guidance"
25.Development of most new drugs from discovery to marketing
1.What must you file before conducting human clinical trials with an exper- imental drug?: IND application (Form FDA 1571)
2.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:
safety updates
copies of new protocols FDA 1572
Annual Progress reports
3.this document notifies FDA of relevant changes in investigators conduct- ing clinical trials under the IND.: Form FDA 1572
4.What is the timeline of drug development?: Preclinical trials, IND Submis- sion,
Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV)
5.When does a sponsor submit the IND?: Prior to clinical development phases (human trials). *30 day process.
6.What is the NDA?: New Drug Application, submitted prior to Phase IV market- ing phase.
7.How long does the NDA submission take?: 6 months - 2 years.
8.What is determined for a drug in the preclinical phase: Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying.
9.How long does FDA have to review IND submission?: 30 days
10.How long is the clinical development phase (Phase 1-III) in process for IND?: 6-7 years.
11.Determine the trial phase:
-Assess toxicity
-Determine drug's PK and PD profiles
-Determine doses resulting in sufficient biological level of drug: Phase I
12.Determine the trial phase:
-Determine drug's effectiveness (primary goal) -Determine long-term drug safety
-Confirm findings: Phase III .Determine the trial phase:
-Determine drug's short-term risk (safety) (primary goal)
-Examine preliminary effectiveness of drug: Phase II
14.Determine the trial phase from the subject population: Controlled studies enrolling limited numbers of patients: Phase II
15.Determine the trial phase from the subject population:
Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers.: Phase III
16.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.: - Phase I
17.If an IND application is submitted and the FDA has not contacted the physician within 30 days after acknowledging receipt, can the trial start?: - 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.
18.What must be provided to investigators before they beginning conduct- ing trials at their site?: Protocol and Investigator's Brochure
19.What regulation must a PI comply with in order to use an edc system for a clinical trial?: 21 CFR Part 11
20. 21 CFR 56.115(b):
21. 21 CFR 312.57:
22. 21 CFR 312.62:
23. 21 CFR 812.140:
24.What happened because of the concern and confusion regarding inter-
pretation of Part 11in 2003.: 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: Comput- erized Systems Used in Clinical Investigations (2007). ** The 2007 guidance "supplements the 2003 guidance"
25.Development of most new drugs from discovery to marketing
