Over the past decade, we’ve gained direct experience from our SimpleCTMS clients who utilize electronic visit reports (EVRs) every day for their study needs. Our clients have managed more than 30,000 EVRs directly in CTMS in over 40 countries around the globe. Additionally, our Client Managers, Product Managers and Support team members are experienced Clinical Trial Managers and former monitors with direct experience creating and reviewing EVRs and trending metrics for their study teams. Finally, our development team knows how to build clean, smart and purposeful CTMS products with the life sciences end user in mind.

We know that utilizing EVRs vastly improves workflow, facilitates compliance with on-time authoring and approving and enables teams to assess critical information quickly and easily. We’ve taken our industry experience and client experiences into consideration, along with a fresh perspective, as we developed EVRs for our on-demand SimpleTrials CTMS solution.

Here are some of the client needs and how we address them in SimpleTrials:

1. Study teams need study-specific EVRs that conform to their SOPs but are also flexible enough to assess critical study needs and regional or local nuances.
   
   In SimpleTrials, report templates can be easily created with standard Q&A or text field responses. Questions can be defined to require a comment or an attachment. Tables can be included to assess common items (e.g. documents collected, action items, consent form review, SAE review, protocol deviations, and Investigational Product accountability). Subtext and instructions can be defined in the template to provide further guidance to the author about study specific nuances or how to interpret an SOP requirement. CROs can utilize sponsor templates for some studies, their templates for other studies.
    
2. From time to time, EVR templates need to be updated. The related activities should be straightforward, quickly available and reasonably priced. Examples include changes in questions, sections, utilization of content from other templates, updates per revised SOPs, or as dictated by sponsor-CRO relationships.
   
   In SimpleTrials, users can create new templates, create new templates based on existing templates or revise existing templates Questions may be revised, instructions revised, and the behavior for required commenting adjusted. Tables can be added or removed and columns may be selected for inclusion. There are no programming fees or waiting for technical assistance—all of this is included in your subscription plan.
    
3. A typical author and reviewer EVR workflow includes emails, alerts and attachments.
   
   With SimpleTrials, EVRs are authored, reviewed and approved directly in the CTMS. Integrated in-app notifications such as due and overdue reports and email alerts come standard. Collaboration of comments and suggestions are easily done. When an EVR is complete, the author designates the approver; this person immediately receives an email alert. Attachments that are associated with the visit report are directly accessible by the reviewer and approver with the EVR. Reports targeted for completion, revision and/or approval are immediately obvious within the visit tracking area of the CTMS.
    
4. Study leads need real-time views of EVRs in progress, sent for review and approved and posted.
   
   In SimpleTrials, the site visit tracking view provides user based views of associated sites and progress of reports. Reports that are in development are easily identified. Reports that have been sent for review or returned for changes include the submission and return dates as well as associated reviewer or approver. Approved reports are noted in the tracking grid with filtering and sorting options available for high volume studies.
    
5. Study teams need to collaborate on template development and user acceptance testing, train team members on features and quickly associate templates to studies for immediate team use.
   
   With SimpleTrials, templates can be previewed at the portfolio level. Teams can see how the template looks and directly enable the template for study use when ready.  Templates can be revised or copied for re-use. Users can associate a template to the Sandbox study or a Training study to learn the functionality.
    
6. Study teams transitioning from externally created visit reports to utilization of EVRs use need ONE place to go to track everything.
   
   The site visit tracking area of SimpleTrials is where users can access visit records associated with a given study. If the report is being manually tracked to completion, users can indicate the appropriate dates from drafting to approval as well as the person serving as the approver. If an EVR template is associated with the study, authors and approvers can manage the development and approval of the EVR directly within the same grid view. Filtering, sorting and exporting help users find what they need quickly.
    
7. Study teams need to have final approved EVRs and attachments automatically available in the eTMF without the need to manually post.
   
   Approved electronically signed EVRs and associated attachments are automatically posted and available in the appropriate site-specific folder in the eTMF Documents area. Users with access to site based folders are able to download and view EVR and related attachments with ease.
    
8. Study teams need action item integration with EVRs and the ability to view and manage action items in between site visits. 
   
   Site and team member action items are displayed cumulatively within the CRA lounge of the given study. Users can specify in the EVR template settings whether to include all non-closed Action Items at the next visit report. Action items that are populated into electronic visit reports for monitor and site resolution can be updated and resolved. Study Managers can easily see action items that originate from visit reports and other sources directly within the SimpleTrials application.
    
9. Study Teams and Sponsors utilize metrics reports to trend compliance to visit report authoring and approval, identify regions or persons that are delayed in their EVRs and assess resourcing across the study.
   
   Exports and metrics reports are available in SimpleTrials to assess report completion compliance against the monitoring plan completion definitions. Individual report progress and percentage on time and late trending reports by person are available standard reports.

All of these Electronic Visit Report features are available via the SimpleTrials Premium Subscription Plans, which start at $99/month with no startup costs and no long term obligation.

Reach out to us if you’d like to learn more or participate in a webinar to see these features for yourself!