Recently, TransPerfect’s Trial Interactive E-Clinical Innovation EU team attended the GCP and Inspection Readiness Conference in Brussels. The focus of this conference is critical: Sponsors must be ready to reconstruct the entire “story” of a clinical trial through timely and comprehensive reporting and documentation.
As per ICH, “Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected…This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.”
GCP and inspection readiness are fast friends. The more an organization is committed to a culture of inspection readiness, the better they are able to demonstrate their care for the patients who have volunteered for treatment. In today’s digital climate, regulatory agencies can expect to not only find the appropriate documentation, but see exactly when a document was archived and the entire detailed audit history of that document. This history sheds light on the efficiency of sponsor processes and the performance of team members contributing to the TMF.
SOPs shed even more light on sponsor processes, as they detail procedures and instructions and are compared against the index and historical actions in the TMF. The space between creating SOPs and execution can pose a compliance challenge and is the source of many inspection findings.
We have witnessed a small biotech fail to review their SOP before beginning work within their electronic system and adding blank and inappropriate documents to the eTMF. These kinds of oversights occur more frequently than we would imagine and are often simply due to lack of resources, lack of internal knowledge on TMF management, lack of training, lack of oversight, or all of the above. Regardless of the cause, these lapses in compliance call into question not only the integrity of the TMF, but the research itself. Regulatory agencies will wonder not only about the documentation and data, but about patient well-being.
All of this said, it surprised me during one of the roundtables that one organization declared it would not invest in training, as they felt it was a waste of time for study personnel. Their position was that employees should already know what needs to be done and how. Inspectors would disagree. In fact, they often will ask for training records during an inspection. It provides proof that team members know how to mitigate risks.
Not only should training be a must-have, teams should get refreshers as well, and the training program should be included in SOPs. Organizations distributing learning through an LMS are able to embed training in their operations with greater efficiency. There, personnel can train on GCP, study protocols, and the latest SOPs. Sponsors can also train their CROs.
A compliance approach to learning management helps track and improve training oversight, but, more importantly, reduces compliance risks. It was stated during the conference, and has been reported in annual inspection finding reports, that one of the most common inspection findings is missing documents. Properly trained personnel are more likely to follow processes that enable you to know what you have in the TMF vs. what you should have and to take action.
Thank you to the GCP and Inspection Readiness Conference for generating spirited dialogue on these important topics. It is important to keep the big picture in view. That means that all of our actions during the course of research are indicators of the well-being of patients in any given clinical trial.
For more information on oversight, check out our post titled An Overview of TMF Oversight.
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