Making the Most of Site Training: Lessons from the Pandemic

The investigator meeting and site initiation visit (SIV) are two critical milestones marking the beginning of a clinical trial for members of the site team.

Traditionally, investigator meetings involve the principal investigator and study coordinator traveling to large conference venues or hotels to view multiple presentations over the course of a few days. Often, the investigator meeting falls well in advance of the site’s target date to enroll a patient, and while these meetings are excellent networking and learning opportunities, learnings may be outdated by the time the site initiates. The SIV follows weeks or months later when the clinical research associate (CRA) arrives at the site. The CRA often arrives with a sizable amount of study-related information to disseminate to the site team. This challenging process is replicated by different CRAs across site teams in other regions or countries.

In some cases, PowerPoint is the best option to present information. When used effectively, it’s easy to use, easy to share, and cost-effective. Also, it is good for well-structured and concise presentations that are less than 10 minutes. If a presentation goes longer than 10 minutes, even the best speakers will start to lose impact.

In particular, SIVs do not lend themselves well to the PowerPoint approach because these meetings are lengthy and involve vast amounts of information. The challenge of presenting engaging and impactful information is compounded in a virtual setting.

Additionally, PowerPoint presentations vary widely between presenters and meetings, which potentially introduces misunderstandings and errors before the study begins. A CRA might present the material perfectly, and attendees may absorb all the information completely, but PowerPoint consistency is not likely.

Ensuring the Remote Investigator Meeting or SIV Meeting is Productive and Useful

Now more than ever, organizations prefer to virtually attend meetings rather than travel to a physical location. While some stakeholders may not view virtual formats as ideal, they still must ensure sites are well prepared and educated to enroll patients into clinical trials. Without gathering staff in person for a meeting or observe their engagement, it may be harder to gauge how much they have learned and how likely they will be to retain it. In this remote world, communicating in an uninteresting or disorganized manner can be disastrous.

To maintain an audience’s attention, look at an alternative approach. Try introducing variety to break up the training formats for the different SIV agenda items. For example, animated video is a well-recognized, impactful format and is very well suited in conveying study designs, disease overview, and IP mechanisms of action. Other sections may be better suited for simply reading and acknowledging a document similar to the narrative approach outlined above (e.g., a discussion around recruitment strategy). Additionally, a concise and well-delivered PowerPoint may suffice (e.g., a study introduction from your respected key opinion leader (KOL).

An added benefit of utilizing different training formats for different items means deploying information online through a site study portal for attendees to complete or view beforehand, allowing for shorter online meetings and more practical and audience-friendly interactions.

Since most informational meetings are currently conducted remotely, relying on a blend of video and other appropriate formats is a more productive way to disseminate information.

Using a site study portal to get information out to sites at the trial outset (as well as through the entire duration of study conduct) provides additional benefits. Deploying and tracking material through a validated 21 CFR Part 11 environment supports inspection readiness. And a portal can also provide analytics to assess engagement, and any presentations can be recorded and deployed as training modules for site staff who join the site team later in the study.

Advarra offers the solution to provide these benefits, reduce variability from presentation content, and offer sponsors and CROs the ability to know exactly how well site staff understands critical content and how prepared they are to operate a successful clinical trial.

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