by Rob Sims
Our projects with global clinical operations teams have revealed some compelling requirements for an eClinical qualification system.
What sponsors are demanding is to gain assurances that clinical researchers around the world have been qualified on all operational and protocol-specific knowledge.
Based on our conversations and projects, we have gathered seven criteria of the eClinical Site Qualification system:
1. Cloud Technology: this enables simultaneous global distribution and convenient “anywhere” access for sites, regardless of their location.
2. High Security: The system must include a secure, validated infrastructure that enables electronic communication with study personnel, overcoming the challenge of opening up a sponsor’s internal firewall to a myriad of external parties; for data integrity purposes, the system should meet the stringent computer validation requirements of the FDA;
3. Ability to Host Content: Rather than have a site manager or clinical researcher review documents that reside on an internal network server, sponsors need to store critical protocols, amendments, patient recruitment criteria, conflicts of interest forms and other documents on a secure server, reducing multiple network sign-ins. A secure content hosting option, then, improves the user experience while eliminating the strain on the company’s IT support team.
4. Integration with Key CTMS and EDC: The site qualification system must easily integrate with the existing clinical ecosystem, which may include the clinical trial management system, document management system, or EDC, enabling a seamless process that presents a researchers’s qualification on the CTMS directly. With integration, site personnel are automatically added to the site qualification system, and protocol amendments automatically trigger new qualification assignments.
5. “Testing Out” of Training: The eClinical qualification solution should enable experienced employees and personnel to “test out” of specific training content, especially if training is an annual requirement, such as core GCP principles. For example, UL can build courses that enable site personnel to “test out” of specific topics, based on an automated “pre-test” that covers the entire course.6. Deliver Flexible Reporting: The eClinical qualification solution should help the sponsor company identify the training status of investigators and other site personnel for future recruitment.
7. Ability to Grant Third-Party Credits: The eClinical qualification solution should enable site managers to “grant” credit to GCP educational activities taken by site personnel, enabling individuals to upload certificates from GCP education activities they have completed.