CCRP flashcards
CCRP · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Informed consent
- The voluntary confirmation of a subject's willingness to participate in a trial, given after receiving adequate information about purpose, risks, benefits, alternatives, and rights, documented by signature and date.
- Belmont Report principles
- Respect for persons, beneficence, and justice. These three ethical principles underpin human subjects protections and guide IRB review of research design, consent, and subject selection.
- Declaration of Helsinki
- A World Medical Association ethical statement establishing principles for medical research involving human subjects, including independent ethical review, informed consent, and favorable risk-benefit assessment.
- Serious adverse event criteria
- Death, life-threatening condition, inpatient hospitalization or prolongation, persistent or significant disability, congenital anomaly, or an important medical event requiring intervention to prevent one of these outcomes.
- Vulnerable population safeguards
- Additional protections for groups such as children, prisoners, pregnant women, and cognitively impaired persons, including surrogate consent, assent requirements, and restricted risk thresholds under 45 CFR 46 subparts.
- IRB composition requirement
- At least five members with varying backgrounds, at least one primarily non-scientific member, at least one independent of the institution, and gender and minority representation when possible.
- Minimal risk definition
- The probability and magnitude of harm are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.
- Source document definition
- Original records and certified copies such as hospital charts, laboratory reports, ECGs, and device tracings from which protocol-required data are transcribed into the case report form.
- Case report form
- A printed, optical, or electronic document designed to record all protocol-required information reported to the sponsor on each trial subject.
- Protocol deviation
- Any departure from the IRB-approved protocol. Deviations affecting subject safety or data integrity must be documented and reported to the sponsor and IRB per policy.
- Investigational product accountability
- The investigator maintains records of receipt, inventory, dispensing, and return or destruction of the investigational product, documenting amounts used and dates for each subject.
- Trial master file
- The sponsor's repository of essential documents demonstrating compliance with GCP and applicable regulations, retained for the required regulatory period after trial completion.
- Waiver of consent criteria
- Requires minimal risk, no adverse effect on rights and welfare, impracticability without waiver, and provision of additional pertinent information afterward when appropriate.
- Assent
- A child's affirmative agreement to participate in research, obtained in addition to parental or guardian permission and tailored to the child's age and comprehension level.
- Equipoise
- A state of genuine uncertainty about which treatment arm is superior, required ethically before randomizing subjects in a comparative clinical trial.
- Therapeutic misconception
- A subject's mistaken belief that research procedures are designed solely for personal benefit rather than to produce generalizable knowledge, a key target of consent education.
- Institutional review board
- An independent committee that reviews, approves, and monitors research involving human subjects to ensure protection of rights, safety, and welfare.
- Continuing review
- Periodic IRB reevaluation of an ongoing study, at intervals appropriate to risk but not less than annually, to confirm that approval criteria continue to be met.
- Data safety monitoring board
- An independent committee that reviews accumulating safety and efficacy data during a trial and recommends continuation, modification, or termination to protect subjects.
- Unanticipated problem
- An incident, experience, or outcome that is unexpected, related or possibly related to participation, and suggests the research places subjects at greater risk than previously known.
- GCP definition
- An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects, ensuring credible data and protection of rights.
- Sponsor responsibilities
- The sponsor initiates and manages the trial, ensures quality systems, selects qualified investigators, provides investigational product, and maintains the trial master file.
- Investigator delegation log
- A document listing all persons to whom the investigator has delegated significant trial-related duties, their roles, signatures, and start and end dates.
- Financial disclosure
- Documentation of investigator compensation and equity interests related to the sponsor, required to identify and manage potential conflicts of interest in trial conduct.
- Justice principle
- Requires fair distribution of research burdens and benefits, preventing overuse of vulnerable groups for risky research while excluding them from potential benefits.
- Beneficence principle
- An obligation to maximize possible benefits and minimize possible harms, underlying the requirement for a favorable risk-benefit ratio before study approval.
- Respect for persons
- Requires treating individuals as autonomous agents and providing additional protection for those with diminished autonomy, realized through informed consent and safeguards.
- Institutional review board quorum
- A meeting may proceed only when a majority of members is present, including at least one member whose primary concern is non-scientific and one independent of the institution.
- Clinical trial registry
- A public database where trial protocol information is registered before enrollment, supporting transparency and reducing selective reporting of results.
- Protocol amendment approval
- Changes to the protocol require IRB/IEC approval before implementation unless needed to eliminate an immediate hazard to subjects, in which case reporting occurs promptly.
- Feasibility assessment
- Evaluation of a site's patient pool, competing trials, staff qualifications, facilities, and prior enrollment performance before sponsor site selection and activation.
- Good clinical practice training
- Documented training in GCP principles required for investigators and site staff, typically refreshed periodically and maintained with continuing education records for certification.