Bringing Agility and Scalability to Study Training

As clinical trials involve more data and stakeholders than ever before, the industry is turning to digital technologies to gain agility and prepare for regulatory inspections. However, when it comes to tracking study-specific training and documentation, many sponsors continue to stretch legacy Learning Management Systems (LMS) well beyond their designed capacities.

Industry-agnostic and homegrown LMS technologies worked well in a centralized and paper-based world, but like a typewriter in the digital age, cannot keep pace with the increasing complexity and scale of modern clinical trials. This has become more evident as the industry emphasizes global multi-site trials and explores digital, decentralized operating models.

Over time, fragmented data housed in different repositories and in various forms, including spreadsheets and paper, increases risks and inefficiency. In an environment dependent on accurate data, this slows trial progress and creates compliance and patient safety risks.

Training is one of the first things inspectors look for

Gaining insights into training methodology is especially important since training is one of the first things that regulators zero in on when inspecting research sites. The FDA has recently cited sites and CROs for inadequate protocol and SOP training and documentation^1,2. Sponsors are well advised to ensure that documentation is clear, complete, and contemporaneous³. This is a challenging and costly goal to deliver with outdated methods and disparate technologies.

Although partners provide significant resources to ensure data integrity and timeliness, trials can last for years, during which protocols and staffing may change dramatically. Information can become obsolete quickly, and siloed data offers partners little insight into overall training compliance and visibility to areas where they need to improve.

Manual and paper-based approaches in training documentation and tracking increases the risk of noncompliance. Assigning and completing version-controlled curriculum adds another level of complexity, as finding the right version of training assignments maintained and housed in multiple repositories is difficult. These factors increase the administrative burden of training management and oversight.

Time consuming data reconciliation and manual eTMF filing

Sponsors are responsible for study-specific training and ensuring that the TMF is inspection ready. They often do this at the end of the study – a painstaking process, by which reconciliation of pieces of data in various repositories or paper is conducted. This incurs signficant time and resources, ultimately lengthening trial timelines.

A better approach would be to allow trial sponsors to define training goals, design curriculum, assign cirriculum to the most appropriate stakeholder, and automatically file training completion certificates in the eTMF all in one system. This unified, cross-functional approach would simplify clinical study-specific training management for all clinical trial partners, improving compliance and reducing costs.

Veeva has recently announced a preliminary version of Vault Study Training to streamline and automate training in a platform that sponsors, CROs, and research sites can use to create, assign, and deliver assignments and file evidence into Veeva Vault eTMF. Using this tool, sponsors can distribute assignments and file training certificates automatically into the eTMF, as well as alert study and site teams immediately when protocols or SOPs change. The tool will also enable continuous improvement by offering trial partners visibility into roadblocks that prevent effective training. Additional benefits will include faster training times, data reconciliation, and elimination of duplicate data.

The tool promises to streamline and automate training in a single platform for all trial partners and ensure visibility to training compliance, critical to inspection readiness in TMF. It is time to realize the impact of disparate methods and fragmented data on clinical trials, and ultimately, the patients behind these trials. Recognizing the strategic importance of study-specific training is key in improving trial speed and efficiency, and strengthening links that connect sponsors, CROs and research sites. Vault Study Training serves as a solution to some of the fundamental challenges facing clinical trials today.

For more information about Vault Study Training, please refer to this press release and web page.

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