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Protocol deviation setting

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 deviations or actual deviations that have occurred in a clinical trial must be recorded to ensure compliance with the study protocol and to avoid such divergence in the future to guarantee the welfare of the research subjects. Usually, it is the responsibility of a clinical research associate or data manager to document the protocol deviations. It is possible that a sponsor includes in their agreement or requires the deviation report in their own provided template.

In CTMS > LIBRARY > Protocol Deviation Template, you create such a template that acquires the details of the occurrence of protocol deviation, like date of occurrence, deviation description, action taken by the site, whether the occurrence is reported to IRB, details of the reviewer, and others.

Once a template is prepared, using the PD Setting functionality, you can associate a template with a study, site, or subject. This way, whenever a divergence related to a study, site, or subject is suspected or occurs, you can record it using the corresponding template.

Protocol deviation setting
Figure 1. Protocol deviation setting

Examples of the study, site, and subject-related protocol deviations are as follows:

  • Study-related divergence. This includes non-compliance with the study protocol, failing to perform a required lab test, performing a study procedure not approved by the IRB, failing to follow a safety monitoring plan, and so on.

  • Site-related divergence. This includes failing to maintain the temperature required to ensure drug efficacy, a shortage of staff at the site, a large number of subjects enrolled at a site, and others.

  • Subject-level divergence. This includes enrolling a participant who did not meet all the inclusion/exclusion criteria, subjects missing their visit window, recruiting a large number of subjects, and so forth.

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.