Lack of critical documentation during trial
Discovery:
4 mos after the Site Initiation Visit (SIV) and two months post–First Patient In (FPI), we identified serious compliance gaps: Site team were not properly trained, Several sub-investigators(SIs) had not submitted mandatory documentation (CVs, GCP certificates, FDFs), FDA 1572 form was incomplete (without SIs info). 2 pts were already enrolled by these Sis without training or valid documentation, a major GCP violation?
Solution:
Issue was escalated to the sponsor. As part of the corrective actions: The CRA was replaced, the Principal Investigator was retrained and 2 additional oversight visits were conducted at 2 and 6 months post intervention to confirm implementation of changes as recommended by Maieutics. Following these actions, no further compliance issues were reported at the site.
Learning lesson and conclusion:
Need Ensuring Oversight and Compliance BEFORE FPI. Every new CRA undergoes a CV review and an oversight visit to ensure they are fully prepared to + manage the clinical trial. Without our intervention, conflicts with ethical or regulatory bodies potentially triggered, site credibility could have been compromised and subject rights placed at risk, Maieutics will start real time documentation for critical documents before protocol submission and during clinal conduct at each site to prevent compliance issues before or immediately after they occur.