CCRC Exam, ACRP CCRC EXAM PREP,
CCRC Exam Prep, ACRP CCRC, *CCRC
Study Set
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
Brainpower
Read More
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)
Legal contract between the clinical site, investigator and sponsor. Regulatory, financial
and ethical implications will be included.
What financial considerations should be included in developing a budget for a
pharmaceutical company sponsored study?
Investigator oversight, study specific procedures and exams, training, pharmacy, site
overhead, subject stipends, data collection, AE and SAE handling, monitoring visits,
regulatory an IRB prep, and other activities associated with the study.
What is the most important factor to consider in a sites decision to participate in
competing clinical trials?
There is an imminent risk for struggle in prioritizing study related activities when a site is
involved in similar clinical trials for different sponsors.
What is the main objective of a phase 2 clinical trial?
To test a new molecule in subjects with the disease of interest to obtain safety
information and preliminary evidence of efficacy.
The FDA is the regulatory agency in the US that oversees the approval process for
drugs, biologics, and medical devices. What form needs to be submitted to the FDA
before starting a clinical trial with unapproved drug?
Investigational new Drug (IND)
In a drug study, what is the most important FDA document that is signed by the PI?
1572- Statement of investigator
Clinical Trial Agreements (CTAs) are:
Contracts between industry sponsors and research sites
The cost of renting additional clinic space for clinical research is an example of:
Indirect Costs
Pre-Award Process
developing the grant or contract proposal and budget, negotiating any sub-awards,
signing and submitting proposal, providing required certifications and essential
documents to the relevant local review committees before the proposal is submitted to
sponsor for review.
Coverage Analysis
Determination of which, if any, subject care costs in a clinical trial must be covered by a
study sponsor.
Medicare Clinical Trials Policy (CTP)
Provides Medicare coverage for Routine costs or qualifying clinical trials when the
routine costs are otherwise billable to Medicare outside of a clinical trial.
Direct Costs
Staffing, pharmacy, IRB, advertising, storage
Post Award Process
, Includes establishing an account, purchasing equipment and supplies, controlling
expenses to ensure compliance with the grant or contract terms, reallocations of funds,
cost sharing, effort reporting, financial reporting to study sponsor and closeout activities
Certificates of Confidentiality (CCoon
another way to protect confidential information by allowing researchers to refuse to
disclose research data for use in "civil, criminal, administrative, legislative or other
proceedings. Will be issued by NIH or HHS agency
Continuing Review of an approved (non-exempt) protocol that was approved by the
convened IRB:
Good Clinical Practice (GCP)
international ethical and scientific quality standard for designing, conducting, recording,
and reporting trials that involve the participation of human subjects
Types of IRB Reviews
Convened board, exempt, or expedited
Primary purpose of a Certificate of Confidentiality (COC) is to:
Protect identifiable research information from forced disclosure
Financial Conflict of Interest (FCOI)
significant financial interest that could directly and significantly affect the design,
conduct, or reporting of research.
US Public Health Service
PHS
Per PHS, Significant Financial Interest can be defined as:
- Equity/stock interests (regardless of value) in a non-publicly traded company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
-Includes spouses and dependent children
Conflict of Interest (COI)
Training required every 4 years
Significant Equity Interest
Any compensation whose value may be affected by study outcome, proprietary interest
in the investigational product, equity interest whose value cannot be readily determined
through reference to public prices, equity exceeding $50,000 in value, and significant
payments of sorts (SPOOS) cumulative of $25,000
Data Safety Monitoring Board (DSMB)
an independent committee, composed of community representatives and clinical
research experts, that reviews data while a clinical trial is in progress to ensure that
participants are not exposed to undue risk
Radiation Safety Committee review is required for studies that:
Involve investigational imaging studies and studies that are not clinically indicated
Who is responsible for establishing a study's data safety monitoring plan (DSMP)
Sponsor
Institutional Biosafety Committees (IBCs) are always responsible for review of research:
Involving recombinant or synthetic nucleic acids regardless of funding
Overall responsibly for personally conducting or supervising the conduct of human
subjects research and for protecting the rights, safety, and welfare of the subjects
enrolled in the research lies with the:
CCRC Exam Prep, ACRP CCRC, *CCRC
Study Set
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
Brainpower
Read More
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)
Legal contract between the clinical site, investigator and sponsor. Regulatory, financial
and ethical implications will be included.
What financial considerations should be included in developing a budget for a
pharmaceutical company sponsored study?
Investigator oversight, study specific procedures and exams, training, pharmacy, site
overhead, subject stipends, data collection, AE and SAE handling, monitoring visits,
regulatory an IRB prep, and other activities associated with the study.
What is the most important factor to consider in a sites decision to participate in
competing clinical trials?
There is an imminent risk for struggle in prioritizing study related activities when a site is
involved in similar clinical trials for different sponsors.
What is the main objective of a phase 2 clinical trial?
To test a new molecule in subjects with the disease of interest to obtain safety
information and preliminary evidence of efficacy.
The FDA is the regulatory agency in the US that oversees the approval process for
drugs, biologics, and medical devices. What form needs to be submitted to the FDA
before starting a clinical trial with unapproved drug?
Investigational new Drug (IND)
In a drug study, what is the most important FDA document that is signed by the PI?
1572- Statement of investigator
Clinical Trial Agreements (CTAs) are:
Contracts between industry sponsors and research sites
The cost of renting additional clinic space for clinical research is an example of:
Indirect Costs
Pre-Award Process
developing the grant or contract proposal and budget, negotiating any sub-awards,
signing and submitting proposal, providing required certifications and essential
documents to the relevant local review committees before the proposal is submitted to
sponsor for review.
Coverage Analysis
Determination of which, if any, subject care costs in a clinical trial must be covered by a
study sponsor.
Medicare Clinical Trials Policy (CTP)
Provides Medicare coverage for Routine costs or qualifying clinical trials when the
routine costs are otherwise billable to Medicare outside of a clinical trial.
Direct Costs
Staffing, pharmacy, IRB, advertising, storage
Post Award Process
, Includes establishing an account, purchasing equipment and supplies, controlling
expenses to ensure compliance with the grant or contract terms, reallocations of funds,
cost sharing, effort reporting, financial reporting to study sponsor and closeout activities
Certificates of Confidentiality (CCoon
another way to protect confidential information by allowing researchers to refuse to
disclose research data for use in "civil, criminal, administrative, legislative or other
proceedings. Will be issued by NIH or HHS agency
Continuing Review of an approved (non-exempt) protocol that was approved by the
convened IRB:
Good Clinical Practice (GCP)
international ethical and scientific quality standard for designing, conducting, recording,
and reporting trials that involve the participation of human subjects
Types of IRB Reviews
Convened board, exempt, or expedited
Primary purpose of a Certificate of Confidentiality (COC) is to:
Protect identifiable research information from forced disclosure
Financial Conflict of Interest (FCOI)
significant financial interest that could directly and significantly affect the design,
conduct, or reporting of research.
US Public Health Service
PHS
Per PHS, Significant Financial Interest can be defined as:
- Equity/stock interests (regardless of value) in a non-publicly traded company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
-Includes spouses and dependent children
Conflict of Interest (COI)
Training required every 4 years
Significant Equity Interest
Any compensation whose value may be affected by study outcome, proprietary interest
in the investigational product, equity interest whose value cannot be readily determined
through reference to public prices, equity exceeding $50,000 in value, and significant
payments of sorts (SPOOS) cumulative of $25,000
Data Safety Monitoring Board (DSMB)
an independent committee, composed of community representatives and clinical
research experts, that reviews data while a clinical trial is in progress to ensure that
participants are not exposed to undue risk
Radiation Safety Committee review is required for studies that:
Involve investigational imaging studies and studies that are not clinically indicated
Who is responsible for establishing a study's data safety monitoring plan (DSMP)
Sponsor
Institutional Biosafety Committees (IBCs) are always responsible for review of research:
Involving recombinant or synthetic nucleic acids regardless of funding
Overall responsibly for personally conducting or supervising the conduct of human
subjects research and for protecting the rights, safety, and welfare of the subjects
enrolled in the research lies with the:
