07/05/2022
Photo by Ryoji Iwata on Unsplash
A recently posted investigator warning letter cited three separate findings. The first was issues with improperly randomizing participants to treatment arms. Participants received the investigational product (IP) instead of the protocol specified ‘other’ drug (which is redacted, so it could be an active marketed drug or possibly a placebo) as was required per protocol. The site’s response is that it was human error, and their corrective action was to remove the unblinded pharmacist, remove the unblinded coordinator, and retrain the staff on IP preparation, dispensation, administration, and documentation.
Another finding was that the independent assessors did not follow procedures required by the protocol to reduce bias. One example was that the sub investigator performed assessments but also reviewed source documents of the same participant as evident by dated signatures. The site’s response was that the unblinding was accidental and due to the investigator and sub investigators’ lack of understanding of their roles. The corrective action was to retrain the coordinator on delegation of responsibilities and the sub investigator on maintaining their role.
A third finding was that a blinded assessor was required per protocol, but the unblinded investigator performed quantitative endpoint assessments. The response from the site stated that the coordinator offered the assessment record to the investigator as an “honest mistake.” Again, the corrective action provided was retraining of staff.
These findings are concerning for the validity and quality of the data and the safety of the participants. The investigator is responsible for the conduct of the study per protocol and should be aware they were not delegated or appropriate to make blinded assessments. The investigator’s responses indicate they may not have a thorough understanding of their roles and responsibilities as an investigator for oversight of the study. The corrective actions do not address how the investigator will prevent further issues at their site but focus on the staff.
Stating that human error is the cause of issues is not specific enough, and retraining may not help if the root cause was not lack of understanding of the training in the first place.
Do you need to learn from issues and reduce the risk of them repeating?
Want to go beyond “retraining” and better meet the spirit and letter of the regulations?
Many times teams default to retraining without truly understanding the root causes of the poor performance.
DIGR-ACT® is a process developed by industry experts to improve critical thinking skills in clinical trials. It helps clinical trial team members manage issues and risks that matter, to dig through and map information to the root cause, then to come to valid conclusions on how to act effectively. Learn more HERE.
- The Clinical Pathways Team
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