RBQM & GCP Glossary

Any unfavourable medical occurrence in a trial participant administered the investigational product, whether or not considered related to the treatment. An adverse event can be any unfavourable and un...

Metadata records that capture details on actions (manual or automated) performed relating to information and data collection. The audit trail shows who performed an action, when it was performed, what...

A data acquisition tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial participant. CRFs may be paper-based or electronic (eCRF). Elec...

A remote evaluation of accumulating data performed in a timely manner by qualified and trained persons using statistical and analytical methods to identify data trends, patterns, and signals that requ...

A central statistical monitoring and RBQM analytics platform that uses advanced statistical methods to detect data anomalies, site-level risks, and potential fraud in clinical trial data. CluePoints i...

A risk-based approach to assuring that computer software used in clinical trials and regulated environments is fit for its intended purpose. CSA represents a shift from traditional Computerised System...

A process of establishing and documenting that the specified requirements of a computerised system can be consistently fulfilled from design until decommissioning. Under ICH E6(R3), the approach to va...

An organization contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. ICH E6(R3) uses the broader term 'Service Provider' to encompass CROs and other enti...

Data that are essential to the evaluation of the quality of the trial results and the protection of trial participants. Critical data should be identified prospectively during trial design and receive...

Trial processes that, if performed inadequately, could affect the quality of critical data or the protection of trial participants. Critical processes are identified during the Quality by Design phase...

A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial. The data originator may be a human (participant or trial staff), a machine (wear...

The degree to which data fulfil key criteria of being Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA), plus Complete, Consistent, Enduring, and Available (ALCOA+). Data integrit...

A clinical trial in which some or all trial-related activities occur at locations other than a traditional clinical trial site. DCT elements may include remote consent, telemedicine visits, direct-to-...

An electronic system designed for the collection, management, and storage of clinical trial data. EDC systems replace paper-based CRFs and provide real-time data access, built-in edit checks, and audi...

An international ethical and scientific quality standard for the planning, initiating, performing, recording, oversight, evaluation, analysis, and reporting of clinical trials. GCP provides assurance ...

The third major revision of the International Council for Harmonisation's Guideline for Good Clinical Practice, finalized in January 2025. E6(R3) represents a fundamental shift from prescriptive monit...

An independent committee established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and relevant efficacy data, and to recommend to the sponsor whether to con...

A process by which a participant or their legally acceptable representative voluntarily confirms their willingness to participate in a trial after having been informed of all aspects relevant to their...

A comprehensive, trial-specific plan that documents the quality management strategy, including identified risks, risk categorization, mitigation strategies, monitoring approach, KRI definitions, thres...

A measurable variable used to detect potential risks to data quality, participant safety, or protocol compliance during a clinical trial. KRIs are monitored centrally and compared against pre-defined ...

A centralized monitoring and RBQM analytics platform developed by Medidata Solutions (a Dassault Systemes company). Detect provides KRI dashboards, statistical signal detection, site risk scoring, and...

Monitoring activities conducted remotely, without physical presence at the investigator site. Off-site monitoring may include remote review of site documents, teleconferences with site staff, and elec...

Monitoring activities conducted at the investigator site by a clinical research associate (CRA) or monitor. Under RBQM, on-site monitoring is targeted and risk-based rather than routine, focusing on i...

A monitoring approach where the type, frequency, and intensity of monitoring activities are proportionate to the risks identified for the trial, the site, or specific data points. High-risk areas rece...

A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. The protocol also provides the background and rationale for the trial. ...

A proactive approach where quality is built into the clinical trial from the design phase, emphasizing prevention rather than detection of quality issues. QbD involves identifying critical-to-quality ...

Pre-specified limits for quality parameters that, when exceeded, indicate a potential systematic issue requiring investigation and corrective action. QTLs are established during trial design as part o...

A systematic process of identifying hazards and evaluating the probability and impact of risks associated with a clinical trial. Risk assessment is performed during trial design (using tools like the ...

A structured tool used during trial planning to systematically identify, assess, and categorize risks associated with a clinical trial. The RACT process typically involves cross-functional teams evalu...

A data pattern or trend identified through centralized monitoring or KRI analysis that indicates a potential quality, safety, or compliance concern requiring further investigation. Risk signals may be...

A monitoring approach that focuses monitoring activities on the risks most likely to affect participant safety and data quality, rather than applying uniform monitoring across all sites and data point...

A systematic, proactive approach to clinical trial quality that integrates risk identification, assessment, control, communication, and review throughout the trial lifecycle. RBQM shifts the paradigm ...

Any unfavourable medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant dis...

The process of reviewing source data for completeness, accuracy, and consistency. Unlike SDV, which focuses on transcription accuracy, SDR evaluates whether the source data themselves are logical, com...

The process of comparing data recorded in the Case Report Form (CRF) or other data acquisition tools with the corresponding source documents to confirm that the data were accurately transcribed. Under...

A set of statistical methods used to monitor and control a process by analyzing variation in key metrics over time. In RBQM, SPC techniques such as control charts, funnel plots, and CUSUM analysis are...

An adverse reaction that meets three criteria: suspected (reasonable possibility the drug caused it), unexpected (nature or severity not consistent with applicable product information such as the Inve...

Pre-defined limits or boundaries set for KRIs and other quality metrics that, when breached, trigger a risk signal requiring investigation. Thresholds may be absolute (fixed values), relative (compare...