CCRC EXAMINATION TEST 2026 QUESTIONS
WITH ANSWERS GRADED A+
◉ Phase 1. Answer: -intro of new drug/investigational product into
humans
-healthy population (exception: oncology and HIV)
-design: single dose, open label, max tolerated dose
-PR, PD, BA, BE, dosing, metabolis
*focus is SAFETY
◉ Phase 2. Answer: -Intro to subjects with disease
-design: compare with placebo (exception: cancer and antibiotics),
double blind
*AIM: define dose
evaluate short term safety and efficacy in patients with disease
dose response, dose tolerance, AE's
◉ Phase 3. Answer: -Evaluate overall benefit to risk in large group of
patients
-broader eligibility, 2 or 3 tx groups. controlled or uncontrolled
*AIM: establish long-term safety and efficacy with selected doses in
broad subject sample
, dosing invervals, drug-drug interactions, risk-benefit
pivotal to FDA approval
◉ Phase 4 - Post Marketing. Answer: Continue to collect long-term
safety data and gather optimal use info
Conduct AFTER regulatory approves IND
Open label
◉ IND - Investigational New Drug. Answer: Application - FDA form
1571
Permit to perform research with a specific investigational new drug on
humans for the first time in the US
Includes: background info, rationale, sponsors plan
Continually amended by sponsors to reflect protocol changes and new
info
Effective 30 days after receipt by FDA
Updated annually by sponsors
◉ Documents/Filing Investigator Only. Answer: 1)Advertisement for
subject recruitment
2) signed inform consent
3) source docs
WITH ANSWERS GRADED A+
◉ Phase 1. Answer: -intro of new drug/investigational product into
humans
-healthy population (exception: oncology and HIV)
-design: single dose, open label, max tolerated dose
-PR, PD, BA, BE, dosing, metabolis
*focus is SAFETY
◉ Phase 2. Answer: -Intro to subjects with disease
-design: compare with placebo (exception: cancer and antibiotics),
double blind
*AIM: define dose
evaluate short term safety and efficacy in patients with disease
dose response, dose tolerance, AE's
◉ Phase 3. Answer: -Evaluate overall benefit to risk in large group of
patients
-broader eligibility, 2 or 3 tx groups. controlled or uncontrolled
*AIM: establish long-term safety and efficacy with selected doses in
broad subject sample
, dosing invervals, drug-drug interactions, risk-benefit
pivotal to FDA approval
◉ Phase 4 - Post Marketing. Answer: Continue to collect long-term
safety data and gather optimal use info
Conduct AFTER regulatory approves IND
Open label
◉ IND - Investigational New Drug. Answer: Application - FDA form
1571
Permit to perform research with a specific investigational new drug on
humans for the first time in the US
Includes: background info, rationale, sponsors plan
Continually amended by sponsors to reflect protocol changes and new
info
Effective 30 days after receipt by FDA
Updated annually by sponsors
◉ Documents/Filing Investigator Only. Answer: 1)Advertisement for
subject recruitment
2) signed inform consent
3) source docs
