CRA (OPS) key terms

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects, ensuring that rights, safety, and welfare are protected and that the data are credible.

A statement of ethical principles issued by the World Medical Association for medical research involving human subjects; it is the ethical foundation cited by many national regulations and by ICH GCP.

An independent committee formally designated to review, approve, and periodically re-review research involving human subjects, with authority to require changes or disapprove a study in order to protect subject rights and welfare.

The IRB-approved written document describing a study's purpose, procedures, risks, benefits, and alternatives, which a subject or legally authorized representative signs and dates voluntarily before any study-specific procedure is performed.

The document describing the objective, design, methodology, statistical considerations, and organization of a trial, which the investigator agrees to conduct in accordance with once it has been approved.

The Statement of Investigator submitted to FDA, by which the investigator agrees to conduct the study according to the protocol and GCP; it identifies the investigator, the site, and any subinvestigators or clinical facilities.

A compilation of clinical and nonclinical data on an investigational product that is relevant to its study in human subjects; it supports the rationale for the trial and the safe conduct of the study.

An evaluation performed before study start to determine whether a site has an adequate patient population, facilities, equipment, and qualified staff to conduct the trial successfully and in compliance with the protocol.

The monitoring visit conducted before the site begins enrolling, at which the monitor trains staff on the protocol, investigational product, and documentation requirements, and verifies that the site is ready to start.

A site document recording which study tasks each staff member is authorized to perform and the date that authority was granted, signed by the investigator, and which must match the tasks actually documented in source records.

A process that uses chance to assign participants to treatment groups, intended to prevent selection bias and support comparability of groups; sites typically use an interactive system and must follow the assigned sequence.

Records that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced; they are filed and retained by both the investigator and the sponsor according to GCP.

The organized collection of essential documents maintained by the sponsor, and the corresponding investigator site file, demonstrating that the trial was conducted in accordance with GCP and applicable regulations; it must be contemporaneous and complete.

Original records, and certified copies of them, such as hospital charts, laboratory reports, and clinic notes, from which study data are derived; they must be attributable, legible, contemporaneous, original, and accurate.

The monitor's comparison of data entered in the case report form against the original source documents, performed to confirm the accuracy, completeness, and consistency of the reported data.

Any change, divergence, or departure from the IRB-approved protocol without prior sponsor and IRB approval; deviations must be documented, assessed for impact on subject safety and data integrity, and reported as required.

The written account prepared by the monitor after each site visit documenting the activities performed, observations, deviations, and follow-up items; it becomes part of the sponsor's permanent study records.

A monitoring approach that combines centralized and on-site activities, directed by identified risks, so that oversight is focused where it matters most rather than relying solely on frequent full source data verification.

Any untoward medical occurrence in a subject administered an investigational product that does not necessarily have a causal relationship with the treatment; it may be a sign, symptom, or disease temporally associated with product use.

An adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, causes persistent or significant disability, is a congenital anomaly, or is an important medical event.

Suspected Unexpected Serious Adverse Reaction: a serious adverse event assessed as possibly related to the investigational product whose nature or severity is not consistent with the investigator's brochure, triggering expedited reporting to regulators and investigators.

The investigator's judgment of the likelihood that an investigational product caused an adverse event, using categories such as related, possibly related, or not related, which in turn determines expedited reporting obligations.

Unanticipated Problem Involving Risks to Subjects or Others: an incident, experience, or outcome that is unexpected, related to study participation, and suggests a greater risk than was previously recognized, and which must be reported to the IRB.

A written report the sponsor submits to FDA after determining that information from a trial indicates a serious and unexpected suspected adverse reaction or another significant safety finding, generally within 15 calendar days.

A pharmaceutical form of an active ingredient or placebo being tested, or used as a reference, in a trial, including an approved product when used in a new way or for a new indication.

A running site record documenting receipt, dispensing, return, and destruction of investigational product, which the monitor reconciles against dispensing records and the quantities expected to have been used.

A deviation of storage temperature outside the range specified for the investigational product; it must be documented, the affected product quarantined as appropriate, and the sponsor notified for a disposition decision.

The process of revealing a subject's treatment assignment; emergency unblinding is permitted when the information is needed for the subject's care and must be documented and reported to the sponsor.

A printed or electronic document designed to record all protocol-required information reported to the sponsor for each trial subject; the data in it should be supported by source documents.

A computerized system used to collect clinical trial data in place of paper case report forms; it must have validated access controls, an audit trail, and electronic signature capability to be acceptable.

A formal request, generated during data review, asking the site to clarify, correct, or confirm data in the case report form; each query must be answered with an explanation, correction, or source citation, and then resolved.

A secure, computer-generated, time-stamped record that allows reconstruction of the creation, modification, and deletion of electronic records, showing who made each change, what changed, and when.

The final monitoring visit at a site, at which the monitor confirms that data are complete and queries resolved, investigational product is fully reconciled, and essential documents are collected before the study files are archived.

The obligation to keep trial records and documents for the period specified by applicable regulations and the sponsor, often at least two years after marketing approval or study termination, and to notify before any destruction.

A mnemonic for data quality attributes: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete, with related expectations of enduring, available, and traceable; source data and records should meet these expectations.