There are plenty of reasons it might be necessary to make a change to an Electronic Data Capture system after data collection has begun for a study. These range from simple to complex and may stem from a protocol amendment. Some examples include:
- Modifications to eCRF labels or instructions to increase usability,
- Addition of new data entry elements to a form, and
- Introduction of a whole new form for collection of a new set of data.
Let’s examine some ways to make these updates as smooth as possible for study personnel, site personnel, and for regulators.
Planning, Planning, Planning
Everyone knows the adage “measure twice, cut once” (and has experienced “measure once, cut nine times”). Planning for mid-study updates is no exception to this rule.
- Characterize the risk. This assessment will drive testing and deployment plans. Making a label change is low risk and can be easily verified. Adding a whole new form to a study, on the other hand, will require more thorough testing and will also necessitate personnel training.
- Thoroughly document the update. Include defining the change and the reason for it. Describe how the update will be implemented and tested. Outline the training materials that will be needed and how training will be administered and confirmed. Regulators will appreciate this documentation and study personnel won’t be challenged to remember how the change was done once the study is ready for submission.
We have found the use of eCRF versions is a tried-and-true strategy for the implementation of mid-study updates. A database field can be used to hold the version of the eCRF at the time the form is first used. Logic can be implemented that changes the look and feel of the eCRF based on the value of that field. This is a very effective way to handle the addition of new data entry fields to a form.
Don’t assume the mid-study update will work the first time it is used! This is almost never the case. Follow these steps to make sure your mid-study update won’t “break” the study.
- Create a test environment. Perhaps this is a separate test database, or maybe it’s a test site. It’s important not to intermix test data with real data in the study database.
- Document the test plan and results. If it isn’t documented, it didn’t happen! The level of testing done should be commensurate with the risk of the mid-study update. The test plan should be detailed enough to demonstrate to regulators that test efforts were well thought through and comprehensive.
- Include a Biostatistician and study personnel in the testing. It’s important to verify any changes to the study database used during analysis. Study personnel can make good recommendations on how training should be conducted.
Training of site and study personnel is critical to the success of the mid-study update. Even the smallest change to a study can cause questions and confusion when staff don’t know about the change in advance. Make sure the level of training is appropriate for the scope and risk associated with the update.
Once a mid-study update has been planned, implemented, tested, and staff have been trained – it’s time to migrate the update to the live study database.
- Plan the deployment during a low activity period. This is especially true if the system will need to be “down” for the change to take effect. It’s never a good idea to make the EDC unavailable when clinicians have subjects in their clinics.
- Announce when the deployment will be made, and then make it clear to all users when the deployment has been completed. This can be done via a log in message or automated notification.
Mid-study updates are a fact of life and shouldn’t be scary. When good planning, implementation, testing, training, and deployment are exercised, Sponsors and CROs will have confidence that their EDC update efforts will be successful and smooth.
We hope you found these best practices practical and helpful! Read the previous article.