Tuesday, November 12, 2024

Dual Enrollment

Can a subject participate in multiple clinical trials simultaneously?

Though not prohibited, but subjects are not allowed to participate in multiple clinical trials simultaneously. This is not a preferred approach, as it can have a detrimental effect on the safety and reliability on the research study (one medicinal product can interfere with the working of another).

How to avoid duplicate enrollment?

To avoid dual enrollment in clinical trials, researchers can utilize centralized subject registries like Verified Clinical Trials or clinicalRSVP.

Verified Clinical Trials: Incepted by experts on clinical field, VCT is a worldwide clinical trials database registry to prevent dual enrollment in clinical trials. It allows the research team to input participant data into the VCT database and then compare this information against the current trial’s inclusion and exclusion criteria. This system can instantly identify if a participant is already enrolled in another trial, has been part of a previous trial, is attempting to enroll in multiple trials simultaneously, or is violating other protocol criteria like washout periods. It’s a straightforward yet highly effective tool that tackles the problem of dual enrollment head-on. As of Feb2024, VCT is the process of developing a facial recognition app to enhance exacting participant verification, which is useful in decentralized and remote trials.

clinicalRSVP: Is a web-based system, accepts subject's fingerprint as input and validates subject's eligibility prior to enrollment. clinicalRSVP utilizes fingerprint scan in order to confirm participant identity. The fingerprint images are not stored in the database. Each fingerprint generates a unique code, and only those codes are stored. This allows clinicalRSVP to house participant eligibility data without collecting or storing the names of participants. clinicalRSVP houses and stores a series of safety and eligibility dates which inform research sites about when a study volunteer is eligible to participate in a clinical trial.

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