CCRC key terms

The ongoing process by which a prospective participant voluntarily agrees to take part in research after receiving information about purpose, procedures, risks, benefits, and alternatives, documented by a signed and dated consent form before any study-specific procedures begin.

A child's or cognitively impaired person's affirmative agreement to participate, obtained in language they can understand, in addition to permission from a legally authorized representative. Dissent should be respected when the person is capable of expressing it.

An individual or judicial body empowered under applicable law to consent on behalf of a prospective participant, such as a parent, guardian, or health care agent, when the participant cannot provide consent personally.

Obtaining informed consent again when study information changes materially, such as new risks, new procedures, or a revised protocol, or when a participant reaches the age of majority or regains decision-making capacity.

Groups whose ability to give voluntary informed consent may be compromised or who face elevated risk, including children, prisoners, pregnant women, economically disadvantaged persons, and those with decisional impairment. Regulations require additional safeguards for their enrollment.

An independent committee that reviews and approves research involving human subjects to protect their rights and welfare. It evaluates protocols, consent documents, and amendments, and conducts continuing review until the study is closed.

A formal, IRB-approved change to a study protocol that alters procedures, eligibility, endpoints, or consent content. Amendments must be approved before implementation, except when needed to eliminate an immediate hazard to participants.

Any departure from the IRB-approved protocol or study plan that does not meet the definition of a protocol violation. Deviations are documented, assessed for participant impact, and reported according to sponsor and IRB requirements.

A significant departure from the approved protocol that may affect participant safety, rights, or the integrity of study data, such as enrolling an ineligible participant or administering the wrong dose. Violations require prompt reporting and corrective action.

An event that is unexpected, related or possibly related to study participation, and suggests the research places participants at greater risk than previously recognized. Such events require prompt reporting to the IRB and sponsor.

Any untoward medical occurrence in a participant, whether or not related to the study intervention. Coordinators capture onset, severity, relationship, treatment, and outcome, and report per protocol timelines.

An adverse event that results in death, is life-threatening, requires hospitalization or prolongs one, causes persistent disability, is a congenital anomaly, or requires intervention to prevent permanent impairment. SAEs are typically reported within 24 hours.

Original records such as medical charts, laboratory reports, and clinic notes that support the data entered on case report forms. It must be attributable, legible, contemporaneous, original, accurate, and complete, with corrections traceable to the person making them.

The paper or electronic record used to collect protocol-required data for each participant for submission to the sponsor. CRF entries must be consistent with source documents and corrected only through documented, auditable edits.

A data quality framework requiring records to be attributable, legible, contemporaneous, original, accurate, complete, and consistent. Coordinators apply it when documenting visits, corrections, and observations in source and study records.

The process of investigating and answering sponsor or monitor questions about discrepant or missing data, then documenting the correction or explanation in the study system so the query can be closed.

A request from the sponsor or data management identifying missing, inconsistent, or questionable data on a case report form, requiring the site to verify against source and respond with a correction or explanation.

The protocol-defined inclusion and exclusion requirements that determine who may enroll. Coordinators document screening against each criterion using source records, and enrolling an ineligible participant is a protocol violation.

A confidential record of all individuals evaluated for study participation, capturing identifiers, dates, eligibility outcomes, and reasons for screen failure. It supports enrollment tracking and is reviewed during monitoring and audits.

A site-maintained record listing participants who signed consent and those who were enrolled, often including assigned study numbers. It is used to reconcile participants with the sponsor and to support monitoring visits.

The process of assigning participants to treatment groups by chance to reduce bias. Coordinators follow protocol procedures, such as an interactive response system, and must not influence or predict assignment.

A design feature in which participants, investigators, coordinators, or outcome assessors are kept unaware of treatment assignment to prevent bias. Unblinding should follow protocol and be documented when it occurs.

The documented tracking of investigational product received, dispensed, returned, and destroyed at the site. Records must reconcile with dispensing to participants and support compliance assessment and sponsor monitoring.

The drug, biologic, or device being tested in a clinical trial, including comparator products in some studies. Sites must store, handle, dispense, and document it according to protocol and applicable regulations.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects. It protects participant rights and safety and ensures credible trial data.

A sponsor or contract research organization visit to verify that the site follows the protocol, GCP, and regulations. Monitors review source documents against case report forms, accountability records, and consent documentation, then issue findings.

A pre-enrollment visit where the sponsor trains site staff on the protocol, systems, and expectations, and confirms the site has adequate facilities, equipment, and qualifications before study activities begin.

The final monitoring visit after enrollment and data collection end, confirming that all queries are resolved, investigational product is reconciled, records are complete, and the site is informed of retention obligations.

A record listing study staff, their roles, and the specific tasks each is authorized to perform, with start and end dates and investigator sign-off. It demonstrates that qualified personnel performed study activities.

A written, approved instruction describing how a site performs a routine activity, such as consent or investigational product handling. Staff are trained on SOPs, and deviations are documented and addressed.

Any medication a participant takes during the study other than the investigational product, including over-the-counter drugs and supplements. Coordinators record name, dose, indication, and dates, and check protocol restrictions.

A structured record of a participant's past and current conditions, surgeries, and allergies collected at screening. It supports eligibility assessment, safety monitoring, and interpretation of adverse events.

Physiologic measurements such as blood pressure, heart rate, temperature, respiratory rate, and oxygen saturation collected at protocol-specified timepoints. Values must be recorded accurately and assessed for clinical significance.

The IRB-approved document that presents study information and documents a participant's agreement. The current version must be used, signed and dated by the participant and the person obtaining consent before study procedures.

The obligation to protect participant identity and study data from unauthorized disclosure. Sites use coded identifiers, secure storage, and restricted access, and share information only as permitted by consent and regulation.

A systematic, independent examination of trial-related activities and records to determine whether they were conducted and documented according to protocol, GCP, and regulations. Audits may be sponsor-initiated or regulator-initiated.

An official review of site or sponsor records and facilities by a regulatory authority, such as the FDA, to verify compliance with applicable laws and trial conduct standards. Sites prepare by maintaining organized, complete records.