Why Sites Prefer Prelude EDC – Part 1 – Integrated Audit Trail

By Editorial Team on December 15, 2021

We consistently get feedback from our clients that their sites prefer working with Prelude EDC. When sites know they will be using a preferred EDC, they are more likely to participate in a study, are better at meeting enrollment objectives, and are more likely to adhere to protocol requirements. This three-part series explores some of the reasons sites prefer Prelude EDC.

We all know that compliance with 21 CFR Part 11 is essential for regulators, but one aspect of such compliance – the audit trail – is also invaluable to site and study personnel. How does Prelude EDC’s audit trail best the competition?

The Audit Trail is on the Form – There’s no need to dig through other pages or files in search of audit trail information. The audit trail is viewable directly on the same form as the clinical data and includes the form’s lock and unlock history. This makes it easier for sites to know when data was entered (and by whom) when queries from study personnel arise. Monitors and regulators also appreciate the easy access.

The Audit Trail Includes Metadata – What is Metadata? Metadata is data about data. In the context of Prelude EDC, this includes change reasons, queries, comments, review history, etc. That’s a lot of information! It’s presented in a way that makes it easy to understand the nature of each entry and who/when the entry or change was made.

The Audit Trail is Sortable – Interested in knowing the order in which data on a form was entered and changed? With Prelude EDC, the audit trail is sortable by field name, date/time, and more. Want to see all entries for a single field grouped together. That’s just a mouse-click away! Want to see the order of all entries/changes? Done!

The Audit Trail Includes Hidden Fields – Hidden fields are used to hold intermediate values for calculations as well as other information such as when notifications were sent and to whom. Want to confirm that a notification about an adverse event was sent to a Monitor? Look in the audit trail. Want to know when a notification was sent to an investigator about a protocol update? Look in the audit trail.

Audit Trail Info can be Included on Reports – Prelude EDC can generate reports that include audit trail information such as the name of the user who entered the data, the date/time of the entry, and the previous value of fields that have changed. This gives study personnel insight into the contemporaneous nature of data entry and the nature of field changes and helps them troubleshoot issues.

The Audit Trail is Viewable when Entering Reasons for Change – Audit trail entries assist in formulating change reasons. When prompting users for reasons for change, Prelude EDC also displays the previous entry for reference. When site personnel can see explicit field changes, it’s easier for them to differentiate between a simple typo and a revision to a clinical observation.

The Audit Trail can be Hidden – Sometimes it’s helpful to “conceal” audit trail information from one or more user roles. For instance, if subjects/owners are logging in to record observations it might be a good idea to “dumb it down” so they don’t see details like the audit trail. Or let’s say there’s a summary image form for a radiologist to log analysis findings. There are hidden fields on the form containing information about the subject/visit each image is associated with. But the radiologist shouldn’t have access to any “context” about individual images (e.g., subject or visit number) that can be found in the audit trail.

The Audit Trail Preserves Blinding – This should be obvious. When fields are masked/blinded to certain roles, users with those roles cannot see any information about the field in the audit trail (or in reports!).

The Audit Trail Info is Included in the Native XML Export and HTML Archive – The metadata for each field on a form is included in the Native XML Export for that form. This information is “human readable”, and since it’s embedded directly with the field definition the association between a field and its’ metadata is easy to see. The audit trail is also included in the HTML archive. This is an excellent reference resource for sites undergoing audits, and for future data reviews.

Field-By-Field Audit Trail – Prelude EDC also supports the ability to update the audit trail as each separate field is entered (as opposed to logging all changed fields when a form is saved). When studies use this capability, sites are better prepared for transitioning when this field-by-field capability is required by regulators in the future.

Stay tuned for Part 2 where we explore the reasons why sites prefer electronic forms that resemble paper forms.

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