As the clinical technology stack gets ever more complex and diverse in its offerings, one must not lose focus on the details. You can procure all the ‘best-in-class’ clinical technologies and still end up frustrated and wondering where the promise of simplicity and automation went. We’ve spoken to many successful colleagues and thought leaders across the industry. The majority agree that technology certainly can assist in easing burden and increasing quality, but as is often the case, the devil is still in the details.
Identifying, qualifying, training (and documenting training) of clinical sites / site staff is a perfect example. The outdated approach of relying entirely on in-person investigator meetings and face-to-face site initiation visits has been in a downward trend for years. Leveraging both live virtual meetings and on-demand training platforms has shortened start-up timelines, reduced burden on site staff, and achieved both efficiency and cost savings for study sponsors. The impact of the COVID-19 pandemic has dramatically emphasized the importance of leveraging technology to support these key processes. However, when technology is introduced into these critical site startup workflows, if we do not pay attention to the details, the approach can backfire and cause problems which outweigh the intended benefits.
Examples of such details are the nuanced differences between a traditional LMS (Learning Management System) and a purposely built CQMS (Clinical Qualification Management System).
Before we examine what makes a CQMS different from an LMS, we ought to first clarify what an LMS is, how it is designed, and why it fails to meet the requirements of supporting the clinical research industry. A traditional LMS is essentially an HR system, designed to support a single organization, delivering and documenting training for employees over time. The user base is entirely internal, working in a controlled environment (i.e. specific locations, firewalled networks, etc.). At any point in time, each employee has a single set of training requirements assigned to them. The “learnings” being administered are based on a single set of structured content managed by an organization’s HR function and guided by the company’s established SOPs.
Now let’s consider some critical issues related to training and documentation in the clinical research industry, with a focus on investigators, site coordinators and other stakeholders in the conduct of clinical trials. First, we must acknowledge that much of the “training” being administered is not really training at all – it’s more about Qualification and Documentation. For example, the vast majority of investigators and site staff conducting trials are thoroughly trained on Good Clinical Practices. Yet this must be documented at the study level, which has given rise to redundant training – a major (and unnecessary) burden on site staff. A traditional LMS cannot track training status for something like GCP across multiple studies. However, a CQMS can manage training documentation for non protocol-specific topics, such as GCP training, across multiple studies or even across multiple study sponsors, eliminating redundant training for site staff. Furthermore, a CQMS, unlike a traditional LMS, has the ability to track training documentation across various training environments, including F2F investigator meetings, virtual investigator meetings, in-person site initiation visits, and of course on-demand training via the CQMS portal.
This increase in speed that clintech enables, also opens the door to easily miss the small things. Countless times we’ve seen sponsors and their vendors clash on how to complete what seems like a simple task, such as working from the same investigator site list. Many clintech applications offer integration options to solve this issue but often fall short of solving the problem, due to the complexity, cost, and timeline of the integration to establish proper connections. This results in more manual labor, having to keep multiple site records up to date including site equipment paperwork, site staff records, training and rater certifications, staff roles and responsibilities, etc.
What does that mean to the bottom line?
The use of a CQMS can drive impact in a number of ways:
- Reduces complexity for sites – provides a single platform for sites to record all their training and qualification documentation quickly and easily.
- Eliminates redundancy of training and information sharing, sponsors will easily know which sites already have the required and certified training for specific rater assessment scales, regulatory training and more.
- Creates a Perpetual State of Inspection ReadinessTM, for both sites and study sponsors.