Study ConductGlossary Term
ICH E6(R3) Section 1.38
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
The clinical research associate serves as the sponsor's primary representative in overseeing trial conduct at investigational sites. This role, sometimes referred to as a clinical monitor, requires a unique combination of scientific knowledge, regulatory expertise, and interpersonal skills to effectively evaluate site performance, identify issues requiring corrective action, and maintain productive relationships with site personnel. CRAs typically hold degrees in life sciences or nursing and receive specialized training in GCP, therapeutic areas, and monitoring practices.
Monitoring activities performed by CRAs serve multiple purposes: verifying that participant rights and safety are protected, confirming that reported trial data are accurate, complete, and verifiable from source documents, and ensuring that the trial is conducted in compliance with the protocol, GCP, and applicable regulations. These objectives are accomplished through a combination of on-site visits, remote monitoring activities, and centralized review of data patterns and trends.
The evolution of monitoring practices has significantly affected the CRA role. Traditional monitoring emphasized complete source document verification during frequent on-site visits. Current approaches, as reflected in ICH E6(R3), emphasize risk-based monitoring that allocates monitoring resources based on the specific risks associated with each trial and site. This evolution requires CRAs to exercise greater judgment in identifying sites and data requiring focused attention, while leveraging technology and centralized monitoring to supplement their direct observations.
Monitoring visit
"During her routine monitoring visit, the CRA verified that all informed consent forms were properly signed and dated, compared laboratory values in the CRF against source documents, and reviewed the investigational product accountability log."
Issue identification
"The CRA identified a pattern of protocol deviations related to timing of study assessments and worked with the site coordinator to implement corrective actions and retraining."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.
ICH E6(R3) Section 1.38
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
The clinical research associate serves as the sponsor's primary representative in overseeing trial conduct at investigational sites. This role, sometimes referred to as a clinical monitor, requires a unique combination of scientific knowledge, regulatory expertise, and interpersonal skills to effectively evaluate site performance, identify issues requiring corrective action, and maintain productive relationships with site personnel. CRAs typically hold degrees in life sciences or nursing and receive specialized training in GCP, therapeutic areas, and monitoring practices.
Monitoring activities performed by CRAs serve multiple purposes: verifying that participant rights and safety are protected, confirming that reported trial data are accurate, complete, and verifiable from source documents, and ensuring that the trial is conducted in compliance with the protocol, GCP, and applicable regulations. These objectives are accomplished through a combination of on-site visits, remote monitoring activities, and centralized review of data patterns and trends.
The evolution of monitoring practices has significantly affected the CRA role. Traditional monitoring emphasized complete source document verification during frequent on-site visits. Current approaches, as reflected in ICH E6(R3), emphasize risk-based monitoring that allocates monitoring resources based on the specific risks associated with each trial and site. This evolution requires CRAs to exercise greater judgment in identifying sites and data requiring focused attention, while leveraging technology and centralized monitoring to supplement their direct observations.
Monitoring visit
"During her routine monitoring visit, the CRA verified that all informed consent forms were properly signed and dated, compared laboratory values in the CRF against source documents, and reviewed the investigational product accountability log."
Issue identification
"The CRA identified a pattern of protocol deviations related to timing of study assessments and worked with the site coordinator to implement corrective actions and retraining."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.