CCRC Exam Questions & Answers 100% Verified
(Grade A+)
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Terms in this set (37)
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
Protocols
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
-intro of new drug/investigational product into
humans
-healthy population (exception: oncology and HIV)
Phase 1
-design: single dose, open label, max tolerated dose
-PR, PD, BA, BE, dosing, metabolis
*focus is SAFETY
, -Intro to subjects with disease
-design: compare with placebo (exception: cancer
and antibiotics), double blind
Phase 2 *AIM: define dose
evaluate short term safety and efficacy in patients
with disease
dose response, dose tolerance, AE's
-Evaluate overall benefit to risk in large group of
patients
-broader eligibility, 2 or 3 tx groups. controlled or
uncontrolled
Phase 3 *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
Continue to collect long-term safety data and gather
optimal use info
Phase 4 - Post Marketing
Conduct AFTER regulatory approves IND
Open label
Application - FDA form 1571
Permit to perform research with a specific
investigational new drug on humans for the first time
in the US
IND - Investigational New
Includes: background info, rationale, sponsors plan
Drug
Continually amended by sponsors to reflect protocol
changes and new info
Effective 30 days after receipt by FDA
Updated annually by sponsors
1)Advertisement for subject recruitment
2) signed inform consent
Documents/Filing 3) source docs
Investigator Only 4) subject enrollment logs
5) final report by investigator to IRB
6) completed subject ID code list
(Grade A+)
Save
Terms in this set (37)
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
Protocols
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
-intro of new drug/investigational product into
humans
-healthy population (exception: oncology and HIV)
Phase 1
-design: single dose, open label, max tolerated dose
-PR, PD, BA, BE, dosing, metabolis
*focus is SAFETY
, -Intro to subjects with disease
-design: compare with placebo (exception: cancer
and antibiotics), double blind
Phase 2 *AIM: define dose
evaluate short term safety and efficacy in patients
with disease
dose response, dose tolerance, AE's
-Evaluate overall benefit to risk in large group of
patients
-broader eligibility, 2 or 3 tx groups. controlled or
uncontrolled
Phase 3 *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
Continue to collect long-term safety data and gather
optimal use info
Phase 4 - Post Marketing
Conduct AFTER regulatory approves IND
Open label
Application - FDA form 1571
Permit to perform research with a specific
investigational new drug on humans for the first time
in the US
IND - Investigational New
Includes: background info, rationale, sponsors plan
Drug
Continually amended by sponsors to reflect protocol
changes and new info
Effective 30 days after receipt by FDA
Updated annually by sponsors
1)Advertisement for subject recruitment
2) signed inform consent
Documents/Filing 3) source docs
Investigator Only 4) subject enrollment logs
5) final report by investigator to IRB
6) completed subject ID code list
