Introducing the Prelude EDC SOP Manager

Why use two different systems to manage clinical data and SOPs?

Organizations who use Prelude EDC will be interested to know that Prelude Dynamics offers an out-of-the-box SOP Management tool.  This flexible tool is implemented using Prelude EDC and supports all the familiar tools and features our user community is familiar with. The SOP Manager fosters compliance by providing notifications in advance of required SOP review dates and is 21 CFR Part 11 Compliant.

The concept of Sites and Subjects is overloaded in the Prelude EDC SOP Manager. Sites are SOP Sections and Subjects are SOPs. Two key areas of functionality are supported: SOP Management and SOP Training Records.

SOP Management

SOPs are authored using any standard text editor (i.e., Microsoft Word) that supports change tracking, and a description of revisions is contained within each document. The following process is used to revise an SOP.

1. With change tracking turned on, a subject matter expert authors/edits the content to comply with current best practices.
2. The edited source document along with a PDF is uploaded to the SOP’s form.
3. A different subject matter expert performs a content review of the SOP and electronically signs off on the SOP’s form.
4. A QA staff member performs a QC review of the SOP and electronically signs off on the SOP’s form.
5. Once the reviews are done, the SOP is finalized.

The SOP List page contains columns that show the effective date, last review date and next required review date for each SOP. These columns can be used to sort the list page and quickly see which SOPs are due for review in the near future. This helps the quality department stay on top of SOP update deadlines.

There is also a feature that allows users to view all the SOPs that were effective on a certain date. This is especially useful when regulators are interested in knowing the state of the organization’s SOPs when a particular clinical trial was conducted. We use the Prelude EDC SOP Manager internally and have noted that auditors find it easy to navigate.

As a bonus, we have an “SOP Management” SOP that we can provide as a template. This template can be used as a baseline and adapted to suit your organization’s process.

SOP Training Records

An important aspect of any organization’s Quality System Management Plan is to record and track staff SOP training. This is done in the context of study users, who each have a demographics form and an annual training form group. This form group contains on-demand forms that can be created for each training session. These on-demand forms are automatically populated with the list of SOPs and are used to record when training on each SOP was completed.

The system supports multiple types of training including “self study”, “group training”, “annual training” and “new employee training”. It also supports an annual training summary for each staff member that facilitates compliance assessment.

Customization Options

While the SOP Management tool can be used “out-of-the-box”, it is natural for organizations to request customizations. Because the tool is implemented in Prelude EDC, these can be accommodated in a fast, cost-effective manner. Some popular customization options include:

• Setting up user roles to match your organization structure.
• Review cycle requirements (e.g., Annual, Biennial, etc.). Internally, we use Biennial – but this can easily be modified.
• Custom summaries.

Conclusion

The Prelude EDC SOP Management tool is an intuitive and flexible system that is already familiar to Prelude EDC users – reducing the training requirements associated with migrating to a new SOP Management tool. It allows organizations to migrate completely away from binders of paper documents and seamlessly integrates staff training – helping to assure compliance.