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Clinical Trial
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
Clinical event, measurable indicator, subject reported response
Feasibility of a Study
Assessment of resource needs, regulator requirements, and potential level of risk of
harm for human subjects participating in study
Necessary controls in Clinical trials
Inclusion/ exclusion criteria(identify target), randomization(avoid bias), Blinding(avoid
observation bias), Primary and secondary endpoints(prove hypothesis)
Current Good Manufacturing Practices
cGMP
Food and Drug Administration (FDA)
federal agency responsible for the regulation and enforcement of drug evaluation and
distribution policies
Investigational New Drug (IND)
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
30 calendar days
Non-significant Risk Devices
Tongue depressor, adhesive bandages
Premarket Review
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)
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
Randomized, controlled, double-blind
Double-blind randomized trial
Neither study staff, nor the subject know the assignment until study is completed
Study Designs
Randomized, controlled, double blind, Observational, Retrospective, Historical
QA/QI
uses retrospective data obtained through chart reviews to evaluate and improve a
process, program, or line of service.
phase 1 study
Assess safety and tolerability of a study drug in mostly healthy subjects
Phase 2 study
, 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
Uses information gathered from Phase 1 and 2 studies to determine safety and
effectiveness.
New Drug Application (NDA)
Phase 1-3 clinical trials prove drug is effective and safe, this application is submitted to
the FDA.
Phase 4 Study
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
Initiator of clinical investigation, overseeing entire process, develops regulatory
strategies, funding source, and manages interactions with regulatory authorities.
Protocol
Formal document containing details of the study design and all the associated
procedures to be followed during the course of the study. Deviations from this can risk
subject safety, damage integrity of trial data, and jeopardize regulatory approval of
product.
Basic elements of a protocol
Objectives, scientific background, Trial design, Selection and enrollment of subjects,
procedure and research events, management of AEs, Statistical considerations, Data
collection and recordkeeping, Quality control, assurance of safety of patients is
protected.
Principal Investigator (PI)
The person who is primarily in charge of research on a project that is sponsored or
funded by an organization. Also responsible for all study conduct, including protecting
human subjects and ensuring the integrity of the data obtained during the course of the
trial.
Statement of Investigator
FDA 1572-Must be signed by all investigators participating under the clinical trial under
the IND. This is an agreement by the investigator to conduct the study in compliance
with FDA regulations
Sub-Investigator
Assists the PI by performing delegated tasks that are outlined in the protocol.
Study Monitor or CRA
Typically employed by the sponsor or CRO and is responsible for evaluating the overall
conduct of the trial at a research site.
Institutional Review Board (IRB)
committee of administrators, scientists, and community members that reviews proposals
for research involving human participants. Oversees the ethical and scientific aspects of
a study, with special focus on risk of harm vs benefit assessment for participating
subjects.
Clinical Trial Agreement (CTA)
Clinical Trial
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
Clinical event, measurable indicator, subject reported response
Feasibility of a Study
Assessment of resource needs, regulator requirements, and potential level of risk of
harm for human subjects participating in study
Necessary controls in Clinical trials
Inclusion/ exclusion criteria(identify target), randomization(avoid bias), Blinding(avoid
observation bias), Primary and secondary endpoints(prove hypothesis)
Current Good Manufacturing Practices
cGMP
Food and Drug Administration (FDA)
federal agency responsible for the regulation and enforcement of drug evaluation and
distribution policies
Investigational New Drug (IND)
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
30 calendar days
Non-significant Risk Devices
Tongue depressor, adhesive bandages
Premarket Review
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)
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
Randomized, controlled, double-blind
Double-blind randomized trial
Neither study staff, nor the subject know the assignment until study is completed
Study Designs
Randomized, controlled, double blind, Observational, Retrospective, Historical
QA/QI
uses retrospective data obtained through chart reviews to evaluate and improve a
process, program, or line of service.
phase 1 study
Assess safety and tolerability of a study drug in mostly healthy subjects
Phase 2 study
, 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
Uses information gathered from Phase 1 and 2 studies to determine safety and
effectiveness.
New Drug Application (NDA)
Phase 1-3 clinical trials prove drug is effective and safe, this application is submitted to
the FDA.
Phase 4 Study
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
Initiator of clinical investigation, overseeing entire process, develops regulatory
strategies, funding source, and manages interactions with regulatory authorities.
Protocol
Formal document containing details of the study design and all the associated
procedures to be followed during the course of the study. Deviations from this can risk
subject safety, damage integrity of trial data, and jeopardize regulatory approval of
product.
Basic elements of a protocol
Objectives, scientific background, Trial design, Selection and enrollment of subjects,
procedure and research events, management of AEs, Statistical considerations, Data
collection and recordkeeping, Quality control, assurance of safety of patients is
protected.
Principal Investigator (PI)
The person who is primarily in charge of research on a project that is sponsored or
funded by an organization. Also responsible for all study conduct, including protecting
human subjects and ensuring the integrity of the data obtained during the course of the
trial.
Statement of Investigator
FDA 1572-Must be signed by all investigators participating under the clinical trial under
the IND. This is an agreement by the investigator to conduct the study in compliance
with FDA regulations
Sub-Investigator
Assists the PI by performing delegated tasks that are outlined in the protocol.
Study Monitor or CRA
Typically employed by the sponsor or CRO and is responsible for evaluating the overall
conduct of the trial at a research site.
Institutional Review Board (IRB)
committee of administrators, scientists, and community members that reviews proposals
for research involving human participants. Oversees the ethical and scientific aspects of
a study, with special focus on risk of harm vs benefit assessment for participating
subjects.
Clinical Trial Agreement (CTA)
