The Curious Case of Re-Screened Subjects

CALIFORNIA CITY, Calif. - Feb. 21, 2022 - PRLog -- In clinical trials, re-screening is allowed wherein subjects are permitted for rescreening if an individual has failed in an earlier attempt. Meanwhile, some subjects fail the screening process due to not meeting inclusion/exclusion criteria. Such individuals who fail screenings will be screened again upon completion of a specific time or meeting a specific criterion as per the protocols and regulatory guidelines. Re-screening is beneficial for both the individual and the sponsor. In case of rare diseases, it becomes beneficial where patient population is limited and hard to recruit. Also, when the clinical trial opts for re-screening, some intriguing questions arise, making the re-screening procedure a curious case.

• What should be the subject identifier (USUBJID) for the re-screened subject?
• How do we trace a subject who has passed screening after multiple attempts?
• What will be the implications on DM?
• What are the standards (SDTMIG) for re-screening?

Let us have a look into these questions and get a deeper insight.
https://www.acldigital.com/blogs/curious-case-re-screened...