Clinical Research Subject Verification Program

clinicalRSVP is a de-identified clearinghouse used by the clinical trials industry to authenticate that study volunteers do not participate in more than one clinical trial at a time.

clinicalRSVP utilizes a simple and secured approach that allows investigators to objectively authenticate study participant eligibility prior to enrollment by:

• Utilizing biometric fingerprint technology
• Maintaining a secured and blinded database validated according to 21 CFR
  Part 11
• Authorizing access to data according to the needs and rights of stakeholders
• Deploying expert administrator capabilities and clinical support

The goal of clinicalRSVP is to improve the clinical trials landscape for all stakeholders by preventing dual enrollment. The prevention of dual enrollment leads to increased accuracy of clinical trial study data and improvement of participant safety.

What it accomplishes

Specifically, clinicalRSVP works to definitively prevent:

• Enrollment of a participant in multiple concurrent clinical trials across various research sites
• Enrollment of a participant in a clinical trial before meeting previous study washout criteria or other protocol inclusion and exclusion requirements related to previous study participation
• Enrollment of a participant in the same trial that they completed at another site

How it works

Potential study participants are authenticated at screening via biometric fingerprint identification. From here clinicalRSVP provides investigators with an informational report on any recent study participation for that participant. Investigators use this information to exclude any participants who have not completed a previous clinical trial or do not meet current trial inclusion criteria.

Upon enrollment, basic eligibility data for enrolled participants is synced to a central blinded database maintained by clinicalRSVP. This data is de-identified and does not include study data.