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Protocol deviation

A protocol deviation is an unintended and unexpected divergence from the expected or Institutional Review Board (IRB)-approved protocol. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion or exclusion criteria, failing to perform a required lab test, and so on.

When a deviation occurs, it is the responsibility of designated personnel (usually a clinical research associate or data manager) to record the details of the protocol deviation. This is necessary to ensure compliance with the study protocol and to avoid such divergence in the future to guarantee the welfare of the research subjects.

The following sections discuss various features available in CTMS for you to easily manage and assess the protocol deviations:

In this section:

Also known as an Independent Ethics Committee (IEC) in the European Union, the Institutional Review Board is a group that is formulated and formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

A participant who is enrolled in a clinical trial and assigned to the site.

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.