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Protocol deviation record

The protocol deviation (PD) occurs when there 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/exclusion criteria, failing to perform a required lab test, and so on.

After you have created and associated the protocol deviation template with a study, site, or subject, you can start recording and managing the records of the deviations. Recording a deviation can be a requirement of the sponsor and is also necessary to avoid such deviations in the future to ensure compliance with the study protocol and the safety of subjects. The protocol deviation records are usually added by a clinical research associate (CRA) or data manager (DM) and reviewed by a medical monitor (MM).

Record page
Figure 1. Record page

The columns of the table may differ based on the selected deviation template. Yet, there are columns present in any case, for instance, SN, which is a sequence number of a record, or Record ID, which is a unique code assigned to a record for identification purposes.

Under the Protocol Deviation > Record functionality of CTMS, you can add and manage the records of the protocol deviation as explained in the following sections:

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.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

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.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).