CRNO key terms

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human participants. It protects participant rights and safety while ensuring trial data are credible and reliable.

The harmonised guideline issued by the International Council for Harmonisation that defines GCP responsibilities for sponsors, investigators, and ethics committees. It is the reference standard most regulators use when inspecting clinical trials.

The individual, company, institution, or organisation that takes responsibility for initiating, managing, and financing a clinical trial. The sponsor ensures the trial is conducted according to the protocol and applicable regulations.

A person who both initiates and conducts a trial, holding sponsor duties and investigator duties at the same time. This typically occurs in investigator-initiated academic studies rather than industry trials.

The qualified person at a trial site who takes responsibility for the conduct of the study and the welfare of enrolled participants. The PI delegates tasks only to appropriately trained and qualified staff.

A qualified clinician who is a member of the trial team and performs study procedures under the direction of the principal investigator. Their duties and start date must be documented on the delegation log.

A company contracted by a sponsor to perform trial-related tasks such as monitoring, data management, or site management. The sponsor remains ultimately accountable for the work the CRO performs.

An independent body that reviews and approves trial protocols, consent forms, and recruitment materials before participants are enrolled. It also conducts continuing review to protect participants' rights and welfare.

A review body, often used outside the United States, that evaluates the ethics of a trial and safeguards participants. Its approval or favourable opinion must be obtained before study activities begin.

A document that describes the objective, design, methodology, statistical considerations, and organisation of a trial. It provides the framework within which the study is planned, executed, and reported.

A written change to or formal clarification of a protocol after initial approval. Substantive amendments generally require ethics committee review and approval before implementation, unless a safety exception applies.

Predefined characteristics that a person must meet to be eligible for enrolment in a trial, such as age range, diagnosis, or disease severity. They help define the population that the results will apply to.

Conditions or characteristics that disqualify a potential participant from enrolling in a trial, often chosen to reduce safety risk or confounding. They are applied together with inclusion criteria during screening.

The process of assessing potential participants against inclusion and exclusion criteria, usually through history, examinations, and tests. Screening occurs only after valid ethics approval and informed consent.

A potential participant who signs consent but does not meet eligibility criteria and is therefore not enrolled. Screen failures are documented and reported, and their data may still require entry.

The ongoing process by which a person voluntarily confirms willingness to participate after receiving and understanding information about the trial. It is documented by a signed and dated consent form.

The written document, approved by an ethics committee, that presents trial information in understandable language and records a participant's agreement. Participants receive a signed copy and may withdraw at any time.

Agreement to participate given by a minor or a person with limited decision-making capacity, obtained in addition to permission from a legally authorised representative. It uses language suited to the person's understanding.

An individual permitted by law to consent on behalf of a participant who cannot give consent themselves. The representative's relationship and authority must be documented in the study records.

Groups whose willingness to volunteer may be unduly influenced or who may lack capacity to consent, such as prisoners, children, or economically disadvantaged persons. They require additional safeguards and justification for inclusion.

The drug, biologic, or other agent being tested or used as a reference in a trial. The sponsor supplies it, and sites must store, dispense, and account for it according to the protocol.

A record tracking the receipt, dispensing, return, and destruction of investigational product at a site. Quantities must reconcile at all times and discrepancies must be investigated and explained.

A period when investigational product is held outside its required temperature range. Excursions must be documented, reported to the sponsor, and assessed for impact before affected product is used.

A process that assigns participants to treatment groups by chance to reduce bias and balance known and unknown factors. Allocation is usually generated centrally and concealed until assignment.

Concealment of treatment assignment from participants, investigators, assessors, or analysts to reduce bias. Unblinding should follow documented procedures and be recorded with the reason.

Revealing a participant's treatment assignment before the planned end of blinding. Emergency unblinding is permitted for safety reasons and must be documented and reported to the sponsor.

Any untoward medical occurrence in a participant given an investigational product, whether or not related to it. AEs are recorded, assessed for severity and causality, and followed until resolution.

An adverse event that results in death, is life-threatening, requires hospitalisation, causes disability, or is a congenital anomaly. SAEs must be reported to the sponsor within defined, usually short, timeframes.

A suspected unexpected serious adverse reaction: a serious event judged possibly related to the investigational product whose nature or severity is not described in the reference safety information. It triggers expedited regulatory reporting.

The investigator's judgement of how likely an adverse event is to have been caused by the investigational product, often recorded as related or not related. It drives reporting decisions and safety evaluation.

The original record, such as a medical chart, laboratory report, or diary, where participant data are first captured. Source documents support the data entered into the trial database and are reviewed during monitoring.

A printed, optical, or electronic document designed to record protocol-required data for each participant. The CRF should capture data consistent with source documents and be controlled for version changes.

The monitor's comparison of data in the CRF or database against original source documents to confirm accuracy and completeness. Findings are documented in monitoring reports and followed up for resolution.

Data quality principles requiring records to be attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available. These principles apply to paper and electronic source records alike.

A secure, computer-generated record showing who created, changed, or deleted electronic data and when, with the reason for each change. It must be retained and reviewable for the life of the record.

A formal request raised by data management or monitoring for clarification or correction of data that appear incomplete, inconsistent, or implausible. Responses must be documented and the resolution retained.

A person appointed by the sponsor to oversee the trial at a site and verify that it is conducted according to the protocol and regulations. The monitor communicates findings and supports corrective actions.

A document describing the monitoring strategy, methods, responsibilities, and frequency for a trial. It may include on-site, central, or risk-based approaches proportionate to the risks identified.

A monitoring approach that focuses effort on the sites, data, and processes posing the greatest risk to participant safety and data quality. It often combines central statistical review with targeted on-site visits.

Any departure from the approved protocol, GCP, or applicable regulations that is not a planned change. Deviations are documented, assessed for participant impact, and reported according to sponsor and ethics requirements.

A structured process for eliminating the cause of a detected problem and preventing its recurrence. CAPAs are tracked to completion and their effectiveness verified, often after audits or serious deviations.

An independent, systematic examination of trial-related activities and documents to determine whether they were performed and recorded as planned. Audits are distinct from routine monitoring and from regulatory inspections.

A regulatory authority's official review of trial sites, sponsors, or contractors to verify compliance with applicable laws and GCP. Inspectors may examine records, facilities, and staff and can take enforcement action.

A record listing study staff and the specific trial tasks each is authorised to perform, with start and end dates. It demonstrates that duties were assigned to qualified personnel and supports accountability.

A computerised system used to collect trial data in place of paper forms. It must include validation, audit trails, access controls, and backup to ensure data integrity and confidentiality.

A document that details the statistical methods and analyses planned for a trial, finalised before database lock. It supports pre-specification and helps prevent selective or post hoc reporting.

The formal point at which the trial database is frozen and no further changes are permitted without documented approval. It follows resolution of outstanding queries and precedes final statistical analysis.