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Email report

In CTMS, the Email Report feature is designed for users to track the most up-to-date list of letters sent or pending sending to confirm or follow up the corresponding monitoring visits.

A monitoring visit refers to an activity when a monitor, usually a clinical research associate (CRA), visits the sites to review and verify study-related activities, including data collection, patient safety, and adherence to the study protocol. The monitor also verifies that the study is conducted in compliance with relevant regulatory requirements and GCP guidelines.

When the monitoring visit is to occur or has already occurred, letters are sent to the site of the monitoring visit to confirm the visit or follow-up on its occurrence.

In CTMS, you can track the letters pertinent to all your study monitoring visits from the two comprehensive reports:

See also
In this section:

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).

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.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

An international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects.