Protocol And Version Control Module

Managing the study throughout its lifecycle is critical. Ensuring that everyone involved in the study has access to the latest protocol and the newest amendment has always been a challenge. Prelude EDC provides a solution – a protocol management module.

The Prelude EDC protocol management module consists of several forms. At the study level, Prelude EDC has a protocol and amendment form that allows the latest protocol to be uploaded into Prelude EDC by simply selecting the file and saving it to the system (see screenshot below). The Amendments section also allows a file to be uploaded for each amendment as well as information that would be useful in quickly understanding the changes. After the first amendment is saved, an additional row appears for subsequent amendments.

Ensuring that everyone has access to the amendment and protocol doesn’t only mean, make it available in a central location, it also means, ensuring there is an audit trail of when it was made available, who made it available and who has viewed it. Prelude EDC keeps a full audit trail of these events.

In addition to ensuring the protocol and amendments are available, it is important to track any protocol deviations that have occurred. Prelude EDC enables this by providing deviation forms at the patient, site and study level. Below is an example of a study level deviation form.

All deviation forms are automatically masked to ensure that masked staff is not accidentally unveiled. Protocol deviations entered by project managers, monitors, and treatment dispensers as well as other roles that are unmasked are automatically masked from everyone else participating in the study. If any of these roles chooses to share the deviation with others, clicking the “share with all” check box prior to saving the deviation will unmask it.

Below is an example of a patient level deviation form that shows a masked deviation as well as three test deviations that were either entered by the role viewing them or shared with all.

A full audit trail of who entered the data is available. Note: If a role is unable to see a particular deviation, they will not be able to see the audit trail for that deviation either.