As a former CRA, I have spent the better part of my career mentoring, teaching, and helping CRAs become competent at monitoring clinical trials to ensure compliance with protocol and GCP. In light of this experience, I urge all CRAs and monitors to STOP THE MADNESS of having CRAs reconduct site training at site initiation visits (SIVs). Instead of retraining sites across all topics, I propose that SIVs focus on retraining sites in their weakest areas.
A focus on evaluating protocol-specific training already conducted at a research site could hold a key to better focusing site initiation visits (SIVs) on critical factors and reducing the amount of time spend on these meetings.
The SIV is used to confirm that a site has hit several milestones needed to be ready to start enrolling patients. These milestones include:
- All staff have been property trained and qualified;
- Any necessary equipment—from e-diaries and electronic data capture (EDC) systems to special equipment like ECGs—is in place and working properly;
- Staff that must use the equipment has appropriate access and is able to use it correctly; and
- The study drug is on-site, properly documented and stored, and in sufficient numbers for the expected number of patients.
The process of evaluating these areas—often including both completion of a feasibility questionnaire and an on-site qualification visit—can eat up as much as 30% of a clinical trial’s timeline, according to a March 2021 blog by Clinical Research IO (CRIO).
Traditionally, all of these areas have been reviewed during an in-person meeting, the SIV. And often, this meeting, in order to check off all of the above boxes, has included long lectures about how to conduct the trial in accordance with the protocol. However, sites, along with some sponsors and CROs, have recently begun to question whether this approach is the most effective and efficient method of confirming a site’s readiness to begin a clinical trial.
And this is spurring some sponsors to question the value of the SIV in its traditional form. A better approach, many sites, sponsors and CROs agree, could be to replace the rote SIV with a more targeted and customized approach.
Why re-conduct training?
A particular area of focus has been in the training of clinical trial staff. Some research sites are pushing back against long, drawn-out SIVs that include a repeat of training their staff have already completed. Many sites believe they gain nothing from this process; rather, it is a box that is being mindlessly checked off.
In theory, if the staff have already been to the investigator meeting and already done online training, this should not need to be re-done. No site staff should need training in the protocol at this point.
And the training provided at the SIV—typically a lecture-type presentation with a slide deck—may not add anything of value to staff capabilities and understanding. A one-size-fits-all lecture by a CRA who is not a trainer is unlikely to correctly target any site-, protocol- or job-specific areas where weaknesses may legitimately exist.
A better approach would be to provide site-specific training only as needed for identified knowledge gaps. The goal must be to make sure that any problems are addressed before a site begins enrolling patients for a new clinical trial. And rote checking off items on a broad, overly generalized to-do list is probably not the best way to accomplish that goal.
Insight available from training metrics
Training systems that use simulation can offer a great tool for sponsors and CRAs to streamline the SIV. For instance, Pro-ficiency’s training approach generates metrics that show how well each participant did during the training and highlights weak areas that may warrant addressing in an SIV. Because the training walks staff through actual protocol scenarios, the metrics can easily flag areas where the protocol may not be well-understood, or where certain staff skills need to be upgraded.
For instance, if the metrics provided show that the PI didn’t understand or struggled with something during training, or that no-one at a given site understood some aspect of the simulation, this information can be used to develop highly targeted training as part of the SIV. In such cases, the SIV could offer an opportunity to run through any specific problematic scenarios again, narrowly targeting only training gaps.
Conversely, if all staff at a site passed their training simulations with flying colors, the sponsor or CRA could correctly conclude that no additional training needs to be included in an SIV.
Metrics like this can act as valuable inputs for creating a customized SIV for an individual site. Anyone with administrator privileges can run reports on Pro-ficiency training results and review the metrics to see who did or did not do well in the training, and where they had difficulty. A CRA can request that information to help determine whether training should be part of a SIV. And if sponsors or CROs have any training concerns, they can ask the CRA to discuss those concerns.
Another approach could be to change the training portion of an SIV from the usual lecture to an opportunity for the site to ask questions based on their experience with the already-completed training. Savvy sites are already doing this, developing lists of questions based on “day-in-the-life” mock runs through the protocol for each position. Many sites may reach out to the sponsor or CRA independently with these questions.
The point is that the focus shifts from the sponsor to the site. This is appropriate, because under GCP requirements, the PI—not the sponsor—is responsible for the quality of the trial, including staff oversight, competency and training.
Focus on site-specific needs
An important consideration is what an SIV is intended to accomplish. In many cases, some of these goals can be achieved using other mechanisms. If that is the case, it makes sense for these things to be done outside of an SIV.
When developing SIVs for individual sites, sponsors and CRAs should strive to do away with anything perfunctory and anything that can be verified otherwise. If a particular site has unique needs, such as specialized equipment, customized program planning or another need, addressing that in an SIV could have value. However, even in those cases, much of that work could be done remotely.
Outside of training, SIVs are used to confirm equipment readiness and correct supply and handling of the investigational drug. If a site is proven to have all of the equipment and drug supplies needed and is ready to start enrollment, it might even be possible to eliminate the SIV altogether and allow that site to begin. And since much of this should have been addressed in training already, the training metrics can be used to identify gaps in these areas.
Both the training portion and the SIV are more effective and valuable if they involve a conversation, rather than someone talking at site staff. This is more easily accomplished by discussing identified problems from previous training in the protocol or on equipment versus subjecting staff to a PowerPoint presentation and lecture that may cover things in which they already are competent, and could also miss areas where confusion does exist.
Even when a formal SIV is warranted, sponsors and sites need to consider whether an in-person meeting is necessary. Many things, even demonstration of equipment availability and staff competency in using it, can be done remotely and involving only the specific personnel necessary.
Another advantage to the selectively targeted SIV approach is how well the process lends itself to being done virtually. For instance, access to systems can be confirmed by checking as an administrator that the necessary people are logged in; this demonstrates the ability to access the necessary systems for data entry and management, communications and other purposes. Similarly, a virtual call via Zoom or other approved platform can be used to view the pharmacy and confirm the presence of necessary equipment.
And the industry seems to be shifting in that direction to some degree. The CRIO blog also indicated that many sponsors and CRAs are increasingly moving to technology to allow more aspects of the SIV process to be conducted remotely.
Virtual meetings can even be used to demonstrate that equipment turns on and functions properly, and to troubleshoot any problems noted. Personnel can even demonstrate proficiency in use of equipment via a virtual call.
Ultimately, it’s important that the SIV process change from a rote, one-way, box-checking approach to a more conversational, interactive, focused and targeted approach that sets sites up for success.
Beth Harper, Chief Learning Officer at Pro-ficiency, is on a mission to eliminate protocol deviations. Beth brings 35-plus years of experience in clinical research operations to Pro-ficiency, utilizing this knowledge along with her years of creating live protocol simulation training to create cutting-edge simulation training programs at Pro-ficiency. Beth has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, protocol optimization, sponsor/site relationship management and clinical research professional competencies. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.