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Potential protocol deviations

A protocol deviation is any change, divergence, or departure from the study design and procedures originally approved and defined in the protocol, consent document, or other study materials.

The potential protocol deviation is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred. It represents a risk or near miss—something that, if left uncorrected, might result in an actual deviation from the protocol requirements.

These risks must be recorded for optimal prevention and efficient handling of the potential protocol deviation—if it ever actually occurs. These deviations are usually recorded by a clinical research associate or data manager using a predefined template that is associated and selected for a study, site, or subject prior to documentation.

In CTMS, the potential protocol deviations are captured in the following ways:

In this section:

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.