CCRP key terms

The ongoing process by which a person voluntarily agrees to take part in research after receiving and understanding information about purpose, procedures, risks, benefits, and alternatives. It is documented but is more than a signature.

A child's or cognitively impaired person's affirmative agreement to participate in research, obtained in language they can understand. Assent supplements but does not replace permission from a legally authorized representative.

An individual or judicial body empowered under applicable law to give permission on behalf of a prospective participant, such as a parent or court-appointed guardian, when the person cannot consent for themselves.

Groups whose ability to give voluntary informed consent may be compromised by circumstances such as imprisonment, cognitive impairment, pregnancy, economic disadvantage, or dependent relationships, requiring additional safeguards in study design and review.

An overt or implied threat, or an excessive offer, that pressures a person to enroll or remain in a study against their true preference, undermining voluntary choice.

An offer or relationship that improperly shapes a decision to participate, often through excessive compensation or authority, without an explicit threat. It differs from coercion in that pressure is subtle rather than overt.

A participant's mistaken belief that research procedures are designed to benefit them personally rather than to produce generalizable knowledge. Investigators must address it during consent discussions.

An independent committee that reviews, approves, and monitors research involving human participants to protect their rights and welfare, applying federal regulations and institutional policies.

Periodic re-evaluation of an ongoing study by the IRB, conducted at intervals appropriate to the degree of risk, to confirm that the risk-benefit balance and consent process remain acceptable.

A level of risk in which the probability and magnitude of harm are no greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

A determination that certain low-risk research categories fall outside most regulatory requirements and need not undergo full or expedited IRB review, though institutional confirmation is still required.

A state of genuine uncertainty within the expert community about which of two treatments is superior, which ethically justifies randomizing participants to either arm of a trial.

Assignment of participants to treatment groups by chance, reducing selection bias and helping ensure that known and unknown confounders are distributed evenly across arms.

Withholding information about treatment assignment from participants, investigators, assessors, or analysts to reduce bias in measurement and reporting. Single, double, and triple blinding describe who is masked.

A systematic error that distorts study results away from the truth, arising from how participants are selected, measured, treated, or analyzed. It differs from random error, which affects precision rather than direction.

Distortion of an exposure-outcome relationship by a third variable associated with both, creating a spurious or masked association unless controlled by design or analysis.

The written plan describing a study's objectives, design, methods, statistical approach, and safety monitoring. It is the controlling document for conduct and requires IRB approval before implementation.

A formal, documented change to an approved protocol that must be reviewed and approved by the IRB before implementation, except when needed to eliminate immediate hazards to participants.

Any departure from the approved protocol without prior IRB approval. Deviations that affect participant safety, rights, or data integrity must be reported promptly to the sponsor and IRB.

Any untoward medical occurrence in a participant, whether or not related to the study intervention. Investigators record, assess causality and severity for, and report these events per protocol.

An adverse event that results in death, is life-threatening, requires hospitalization or prolongs it, causes persistent disability, or is a congenital anomaly, requiring expedited reporting.

An incident that is unexpected, related to participation, and suggests a greater risk of harm than previously known, triggering prompt reporting to the IRB and sponsor.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human participants, ensuring credible data and protection of rights.

Original records such as medical charts, laboratory reports, and progress notes that support the data entered into the case report form and permit verification during monitoring.

A printed or electronic document designed to capture protocol-required data for each participant, which is later verified against source records during monitoring and auditing.

The completeness, accuracy, consistency, and traceability of study data from collection through analysis, supported by audit trails, access controls, and documented corrections.

The individual, company, institution, or agency that initiates and takes responsibility for a clinical trial, including its financing, oversight, and regulatory submissions.

The qualified person who conducts the trial at a site, directs the research team, ensures protocol compliance, and bears responsibility for participant safety and data quality.

The documented process by which the principal investigator assigns specific study tasks to qualified staff, recorded on a log so responsibilities and qualifications are traceable.

Predefined characteristics that determine who may or may not enroll in a study, protecting participant safety and supporting the scientific validity of the sample.

The process of evaluating prospective participants against eligibility criteria, typically under a separate consent, before enrollment and randomization.

The probability that a study will detect a true effect of a specified size, determined by sample size, effect magnitude, variability, and the chosen significance level.

The number of participants planned for a study, calculated to provide adequate power for the primary endpoint while balancing ethical limits on unnecessary exposure.

A foundational U.S. document articulating three ethical principles for human subjects research: respect for persons, beneficence, and justice. These principles underpin modern regulations and IRB review.

The ethical principle requiring that individuals be treated as autonomous agents and that those with diminished autonomy receive protection, operationalized largely through informed consent.

The ethical obligation to maximize possible benefits and minimize possible harms, requiring a favorable risk-benefit assessment before research proceeds.

The ethical principle requiring fair distribution of research burdens and benefits, so that no group bears disproportionate risk or is unfairly denied access to proven interventions.

An international statement of ethical principles for medical research involving human participants, developed by the World Medical Association and widely referenced in national regulations and journal policies.

A situation in which financial or personal interests could improperly influence professional judgment or the conduct and reporting of research, requiring disclosure and management.

Fabrication, falsification, or plagiarism in proposing, performing, or reporting research. It excludes honest error and differences of opinion, and is distinct from regulatory noncompliance.