Clinical Research Fastrack Exam
Questions and Answers with Verified
Solutions | Latest Updated 2026
Association of Clinical ACRP
Research Professionals
Society of Clinical Research SOCRA
Associates
Contract Research CRO
Organization
International Council of ICH
Harmonization
Good Clinical Practice. GCP
Regulations and requirements
with which clinical studies
must comply. These
regulations apply to
manufacturers, sponsors,
clinical investigators and
institutional review boards.
Investigational New Drug IND
New Drug Application NDA
, Electronic Data Capture EDC
1st time tested in humans, Phase 1 clinical trials
small number of subjects
enrolled, looks closely at PK's
and is concerned mostly with
safety
A few hundred subjects Phase 2 clinical trials
enrolled, start to look at
efficacy of drug, see if dose
from phase 1 is effective
There are hundreds to Phase 3 clinical trials
thousands of subjects
enrolled. Here is where we
start to look at long term
effects of the drug
Institutional Review Board, IRB
review research in advance to
ensure ethical considerations
are met
Pharmacokinetics PK
Case Report Form CRF
Serious Adverse Event SAE
Adverse event AE
Questions and Answers with Verified
Solutions | Latest Updated 2026
Association of Clinical ACRP
Research Professionals
Society of Clinical Research SOCRA
Associates
Contract Research CRO
Organization
International Council of ICH
Harmonization
Good Clinical Practice. GCP
Regulations and requirements
with which clinical studies
must comply. These
regulations apply to
manufacturers, sponsors,
clinical investigators and
institutional review boards.
Investigational New Drug IND
New Drug Application NDA
, Electronic Data Capture EDC
1st time tested in humans, Phase 1 clinical trials
small number of subjects
enrolled, looks closely at PK's
and is concerned mostly with
safety
A few hundred subjects Phase 2 clinical trials
enrolled, start to look at
efficacy of drug, see if dose
from phase 1 is effective
There are hundreds to Phase 3 clinical trials
thousands of subjects
enrolled. Here is where we
start to look at long term
effects of the drug
Institutional Review Board, IRB
review research in advance to
ensure ethical considerations
are met
Pharmacokinetics PK
Case Report Form CRF
Serious Adverse Event SAE
Adverse event AE
