Problems

Some of the EDC challenges that needed to be overcome included:

• Tracking alternative methods of conducting visits

• Enabling workflow to accommodate alternative visits

Solution

For one study, the CRO used Calyx’s EDC Design Tool to create a COVID Impact page which captured the details of how COVID impacted study participation. Questions were created to capture the occasions where a scheduled visit or treatment was missed or delayed due to a COVID related issue. If the visit was conducted as scheduled, a data point was created to capture whether it occurred via telephone, video, or a health practitioner’s visit to the patient’s home.

Depending on the method in which the visit took place, specific CRFs were triggered for data entry. For example, if the visit was conducted in the clinic, the Vital Signs and Physical Exam forms would publish, but not in the case of a telephone visit. If the visit was conducted via telephone, the telephone contact form would publish. Implementing these conditional forms simplified processes for site personnel, sparing them from having to identify forms that were not applicable and having to take the extra step of marking those CRFs not collected in the system.

To assist with workflow, queries were configured based on how the visit was conducted. For example, if the visit was conducted via telephone, a query was issued to remind the site to complete the Adverse Event and Concomitant Medication forms. These reminders prevented missing or incomplete data and forms.

These changes to the Calyx EDC configuration demonstrate the system’s flexibility in adapting to the needs of clinical trials in the COVID era.

Result

The flexibility of Calyx’s EDC system allowed the sponsor to adapt to a hybrid decentralized trial model, giving them traceability of how data points were collected to support the validity of the data.