Technology in Registries and Observational Studies - What You Should be Considering (Part I)

Technology in Registries and Observational Studies - What You Should be Considering (Part I)

Many sponsors utilize registries and observational studies when gathering real-world evidence in the post-marketing environment. When designing and implementing these effectively, the technological platforms supporting should not go unnoticed. There are a number of considerations that can help ensure success with your implementation. To help you navigate, we put together a two-part blog detailing what sponsors should keep in mind when designing platforms for their registries and observational studies.

Are your sites and/or investigators familiar with industry terminology or platforms? Are they seasoned vets or just being introduced?

How much burden is being placed on the site? Will advanced technology lighten an already heavy load on existing staff in terms of data collection? Some items to consider include:

  • Simplicity in design that allows quick access to patient information and forms
  • Ability to save partial information
  • Allowing a user to return to access at a later time
  • Displays consistent with paper form layout
  • Allowing the patient direct access to the platform for data entry

Data Cleaning
In a registry study, the chance of receiving a data correction form is minimal, making it critical to collect data as completely and cleanly as possible up front. To do this, the platform used needs to support edit checks that execute against each data collection field, compare data to fields on other pages, and compare data to fields on other forms from other visits. This will provide quicker feedback on fields that are out of range and minimize data entry time.

The platform used should also have the ability to hide fields, pages or forms that are not relevant. This will ensure data that does not apply is not collected and will not have to be queried later for a resolution.

Supporting documentation is sometimes needed for these types of programs, ranging from simple lab results to MRI images. The platform should support the ability to upload a variety of documents that can then be reviewed either together with the patient records or anonymously across all patients by an adjudicator.

Notifications / Compliance
The longer patients are followed, the more risk for non-compliance and decreased data collection. Follow-up notifications to patients and portals for call center personnel should be utilized. The most common methods of communication should be supported: e-mail, fax, text messaging, and automated calls.

The list above should provide a great jumping off point for your platform design. If you have any questions or could benefit from technology consultation from industry experts, our team is happy to help! Please do not hesitate to contact us.

Check back with us for Part II, where we will discuss dashboards, customization and flexibility, size and length, and reporting.