CCRC Exam Questions with Correct Answers
Clinical Trial Correct Answer-process of studying human subjects to
assess the effect of a particular intervention (Drug, biologic, device,
procedure or behavior change) on a pre specified set of measurable
events.
Endpoint or Outcome Correct Answer-Clinical event, measurable
indicator, subject reported response
Feasibility of a Study Correct Answer-Assessment of resource needs,
regulator requirements, and potential level of risk of harm for human
subjects participating in study
Necessary controls in Clinical trials Correct Answer-Inclusion/
exclusion criteria(identify target), randomization(avoid bias),
Blinding(avoid observation bias), Primary and secondary
endpoints(prove hypothesis)
Current Good Manufacturing Practices Correct Answer-cGMP
Food and Drug Administration (FDA) Correct Answer-federal agency
responsible for the regulation and enforcement of drug evaluation and
distribution policies
Investigational New Drug (IND) Correct Answer-application to the FDA
that contains all the animal and cell testing data
,Length of time a sponsor must wait before starting clinical trials after
IND submission to FDA Correct Answer-30 calendar days
Non-significant Risk Devices Correct Answer-Tongue depressor,
adhesive bandages
Premarket Review Correct Answer-FDA process to evaluate the safety
and effectiveness of devices that support or sustain human life, or which
present a potential, unreasonable risk of illness or injury
Investigational Device Exemption (IDE) Correct Answer-Submission to
FDA for significant risk device before a clinical trial can begin, that
allows the investigational device to be used to collect safety and
effectiveness data required to support Premarket Approval application
(PMA)
Gold standard of Study Design Correct Answer-Randomized, controlled,
double-blind
Double-blind randomized trial Correct Answer-Neither study staff, nor
the subject know the assignment until study is completed
Study Designs Correct Answer-Randomized, controlled, double blind,
Observational, Retrospective, Historical
, QA/QI Correct Answer-uses retrospective data obtained through chart
reviews to evaluate and improve a process, program, or line of service.
phase 1 study Correct Answer-Assess safety and tolerability of a study
drug in mostly healthy subjects
Phase 2 study Correct Answer-Focuses on obtaining evidence of
therapeutic efficacy indicating that the molecule has the desired effect.
Performed in subjects with specific condition targeted by investigational
product.
Phase 3 Study Correct Answer-Uses information gathered from Phase 1
and 2 studies to determine safety and effectiveness.
New Drug Application (NDA) Correct Answer-Phase 1-3 clinical trials
prove drug is effective and safe, this application is submitted to the
FDA.
Phase 4 Study Correct Answer-FDA has approved a drug and it is
commercially available, but may be necessary to gather more
information about product through controlled clinical trial, also known
as a post market trial.
Study sponsor Correct Answer-Initiator of clinical investigation,
overseeing entire process, develops regulatory strategies, funding
source, and manages interactions with regulatory authorities.
Clinical Trial Correct Answer-process of studying human subjects to
assess the effect of a particular intervention (Drug, biologic, device,
procedure or behavior change) on a pre specified set of measurable
events.
Endpoint or Outcome Correct Answer-Clinical event, measurable
indicator, subject reported response
Feasibility of a Study Correct Answer-Assessment of resource needs,
regulator requirements, and potential level of risk of harm for human
subjects participating in study
Necessary controls in Clinical trials Correct Answer-Inclusion/
exclusion criteria(identify target), randomization(avoid bias),
Blinding(avoid observation bias), Primary and secondary
endpoints(prove hypothesis)
Current Good Manufacturing Practices Correct Answer-cGMP
Food and Drug Administration (FDA) Correct Answer-federal agency
responsible for the regulation and enforcement of drug evaluation and
distribution policies
Investigational New Drug (IND) Correct Answer-application to the FDA
that contains all the animal and cell testing data
,Length of time a sponsor must wait before starting clinical trials after
IND submission to FDA Correct Answer-30 calendar days
Non-significant Risk Devices Correct Answer-Tongue depressor,
adhesive bandages
Premarket Review Correct Answer-FDA process to evaluate the safety
and effectiveness of devices that support or sustain human life, or which
present a potential, unreasonable risk of illness or injury
Investigational Device Exemption (IDE) Correct Answer-Submission to
FDA for significant risk device before a clinical trial can begin, that
allows the investigational device to be used to collect safety and
effectiveness data required to support Premarket Approval application
(PMA)
Gold standard of Study Design Correct Answer-Randomized, controlled,
double-blind
Double-blind randomized trial Correct Answer-Neither study staff, nor
the subject know the assignment until study is completed
Study Designs Correct Answer-Randomized, controlled, double blind,
Observational, Retrospective, Historical
, QA/QI Correct Answer-uses retrospective data obtained through chart
reviews to evaluate and improve a process, program, or line of service.
phase 1 study Correct Answer-Assess safety and tolerability of a study
drug in mostly healthy subjects
Phase 2 study Correct Answer-Focuses on obtaining evidence of
therapeutic efficacy indicating that the molecule has the desired effect.
Performed in subjects with specific condition targeted by investigational
product.
Phase 3 Study Correct Answer-Uses information gathered from Phase 1
and 2 studies to determine safety and effectiveness.
New Drug Application (NDA) Correct Answer-Phase 1-3 clinical trials
prove drug is effective and safe, this application is submitted to the
FDA.
Phase 4 Study Correct Answer-FDA has approved a drug and it is
commercially available, but may be necessary to gather more
information about product through controlled clinical trial, also known
as a post market trial.
Study sponsor Correct Answer-Initiator of clinical investigation,
overseeing entire process, develops regulatory strategies, funding
source, and manages interactions with regulatory authorities.
