CCRA key terms

Any departure from the approved study protocol that does not significantly affect participant safety, rights, or the reliability of study data, such as a visit performed slightly outside the allowed window.

A serious departure from the protocol that may compromise participant safety, rights, or data integrity, such as enrolling a participant who fails key eligibility criteria or missing a critical safety assessment.

The written document, approved by an ethics committee, that explains a study's purpose, procedures, risks, benefits, and alternatives, and which a participant signs voluntarily before any study-related activity begins.

A child's or cognitively impaired person's affirmative agreement to take part in research, obtained in language they understand, alongside the legally authorized representative's permission.

A person permitted by law to consent on behalf of a participant who cannot consent for themselves, such as a parent, guardian, or court-appointed decision-maker.

An independent committee that reviews and approves research involving human participants, ensuring that risks are minimized and that participants' rights and welfare are protected.

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

A statement of ethical principles for medical research involving human participants, first adopted in 1964 and periodically revised, forming a foundation for modern research ethics.

Any original record, such as hospital charts, laboratory reports, or participant diaries, containing the information first recorded about a participant and used to verify data entered into the study database.

The process of comparing data entered in the case report form or electronic system against the original source records to confirm accuracy, completeness, and consistency.

A printed or electronic document designed to record all protocol-required information about each participant for reporting to the sponsor.

A formal request from the sponsor or data management team asking the site to clarify, correct, or explain data that appear missing, inconsistent, or out of range.

A scheduled or unscheduled on-site or remote review by the sponsor's representative to verify that the study is conducted according to the protocol, Good Clinical Practice, and applicable regulations.

The meeting held at a site before enrollment begins, at which the monitor trains staff on the protocol, confirms readiness, and reviews regulatory and study procedures.

The final monitoring visit after the last participant completes the study, confirming that all data are resolved, investigational product is accounted for, and records are archived.

The drug, biologic, device, or placebo being tested or used as a reference in a clinical trial, including its storage, dispensing, and accountability at the site.

A record documenting receipt, dispensing, return, and destruction of investigational product at a site, allowing reconciliation of quantities shipped against quantities used.

A period during which an investigational product is stored outside its allowed temperature range, requiring documentation, assessment of impact, and sponsor notification.

The process of assigning participants to treatment groups by chance, reducing selection bias and helping ensure comparability between arms.

A design feature that conceals treatment assignment from participants, investigators, assessors, or analysts to reduce bias in reporting and evaluation of outcomes.

The emergency or planned disclosure of a participant's treatment assignment, which must be documented and reported to the sponsor and often to the ethics committee.

Any untoward medical occurrence in a participant given an investigational product, whether or not considered related to that product.

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

A suspected unexpected serious adverse reaction: a serious adverse event that is assessed as related to the investigational product and is not listed in the investigator brochure or reference safety information.

The investigator's judgment of how likely an adverse event is to have been caused by the investigational product, often expressed as unrelated, unlikely, possible, probable, or definite.

A compilation of clinical and nonclinical data on an investigational product that informs investigators about its rationale, dosing, and known risks.

The inclusion and exclusion requirements that determine whether a person may enroll in a trial, based on factors such as age, diagnosis, organ function, and prior therapy.

The period of assessments before enrollment used to determine whether a candidate meets eligibility criteria and to establish baseline values.

The set of measurements taken before treatment begins against which later changes are compared, such as tumor size, blood pressure, or laboratory values.

A pre-specified outcome measure used to assess the effect of treatment, such as a change in a biomarker, time to progression, or occurrence of an event.

The collection of regulatory documents at a site, including approvals, agreements, curricula vitae, and delegation records, that demonstrates the study's compliance.

A record listing study tasks and the site staff authorized to perform them, signed by the principal investigator, showing that duties were assigned to qualified personnel.

The qualified person at a site who leads the conduct of the trial, is responsible for participant safety and data integrity, and signs key documents.

A qualified clinician at the site who performs study-related procedures and makes decisions under the direction of the principal investigator.

A written summary sent to the site after a monitoring visit that lists findings, action items, and agreed timelines for resolution.

The process of raising unresolved or serious issues, such as persistent noncompliance or safety concerns, to higher levels of the sponsor or site organization for action.

The obligation to protect participants' identities and personal information, using coded identifiers in study records and restricting access to authorized personnel.

Groups whose ability to give voluntary consent may be limited, such as children, prisoners, pregnant women, or economically disadvantaged persons, requiring additional safeguards.