CCRC EXAM UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
Question:
1. Protocols
Answer:
1) General Information
2) Background info
3) Trial objectives and purpose
4) Trial design
5) Selection and withdrawal of subjects
6) Treatment of Subjects
7) Assessment of Efficacy
8) Assessment of Safety
9) Statistics
10) Source Data/Docs
11) Quality control/assurance
12) ethics
13) data handling and record keeping
14) financing and insurance
15) publication policy
16) supplements
Question:
2. 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
Question:
3. 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
Question:
4. 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
, Question:
5. Phase 4 - Post Marketing
Answer:
Continue to collect long-term safety data and gather optimal use info Conduct AFTER regulatory approves
IND Open label
Question:
6. 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
Question:
7. Documents/Filing Investigator Only
Answer:
1)Advertisement for subject recruitment
2) signed inform consent
3) source docs
4) subject enrollment logs
5) final report by investigator to IRB
6) completed subject ID code list
Question:
8. Documents/Filing Sponsor Only
Answer:
1) sample of label attached to IP container
2) certificate of analysis of IP product shipped
3) master randomization list
4) pre-trial monitoring report
5) certificate of analysis for new batched of IP
6) monitoring visit reports
7) audit certificate
8) final trial close-out monitoring report
9) treatment allocation and decoding docs All other forms are in BOTH sponsor and investigator files
Question:
9. Form 1572 - Statement of Investigator
CORRECT ANSWERS
Question:
1. Protocols
Answer:
1) General Information
2) Background info
3) Trial objectives and purpose
4) Trial design
5) Selection and withdrawal of subjects
6) Treatment of Subjects
7) Assessment of Efficacy
8) Assessment of Safety
9) Statistics
10) Source Data/Docs
11) Quality control/assurance
12) ethics
13) data handling and record keeping
14) financing and insurance
15) publication policy
16) supplements
Question:
2. 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
Question:
3. 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
Question:
4. 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
, Question:
5. Phase 4 - Post Marketing
Answer:
Continue to collect long-term safety data and gather optimal use info Conduct AFTER regulatory approves
IND Open label
Question:
6. 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
Question:
7. Documents/Filing Investigator Only
Answer:
1)Advertisement for subject recruitment
2) signed inform consent
3) source docs
4) subject enrollment logs
5) final report by investigator to IRB
6) completed subject ID code list
Question:
8. Documents/Filing Sponsor Only
Answer:
1) sample of label attached to IP container
2) certificate of analysis of IP product shipped
3) master randomization list
4) pre-trial monitoring report
5) certificate of analysis for new batched of IP
6) monitoring visit reports
7) audit certificate
8) final trial close-out monitoring report
9) treatment allocation and decoding docs All other forms are in BOTH sponsor and investigator files
Question:
9. Form 1572 - Statement of Investigator
