Practical Site Perspective on IRT and Wider eClinical Systems
Joel Jerome, Pharmacist, Investigational Drug Services, Boston Children's Hospital at Boston Children's Hospital; Michael Scoville, IDS Technician Supervisor, Investigational Drug Services at Boston Children's Hospital; Samuel Bliss, Pharmacy Manager, Investigational Pharmacy Services at Boston Medical Center; Michelle Coughlin, Clinical Research Assistant II, Study Coordinator at Boston Children's Hospital
Samuel Bliss, Pharmacy Manager at Boston Medical Centre; Michelle Coughlin, Study Coordinator at Boston Children’s Hospital; Joel Jerome, Pharmacist at Boston Children’s Hospital; and Michael Scoville, IDS Technical Supervisor at Boston Children’s Hospital, engaged in a fireside chat at the 2023 Interactive Response Technologies (IRT) conference in October in Boston. The conversation focused on the achievements and challenges within IRT and eClinical systems.
How Investigational Products Are Processed in IRT
Bliss began the discussion by providing an overview of the standard workflow for processing investigational products, noting that it is a collaborative effort involving key team members and specialized systems. The study coordinator uses the IRT system to manage patient randomization based on specific inclusion and exclusion criteria. Bliss emphasised that this step is crucial for ensuring precise patient selection. Once randomized, the coordinator alerts the pharmacy manager who accesses the IRT system to gather necessary documents. This initiates the process for dispensing investigational products.
Then, process execution was explained, starting with a meticulous review of the informed consent form to ensure accuracy. Epic, Boston Medical School’s electronic medical record system, is used to place an order for the medication. Following this, Vestigo, a system that specializes in compliance with state and federal labelling requirements, is used for dispensing the medication. Bliss said this system helps with accountability by ensuring adherence to regulatory standards throughout the dispensing process.
Returns are not handled by pharmacy staff but instead managed by a study coordinator like Coughlin, who manages returns by entering relevant information into a IRT system to maintain accurate tracking and documentation.
Coughlin explained this process to the audience from her perspective as a study coordinator, describing the role as an “interface between the patient and the pharmacy.” While some studies require the coordinator to manually log information into IRT, others have patient questionnaires that communicate directly with the system.
Jerome described this workflow as standard, stating that “the processes at Boston Children’s Hospital are very similar.” He shared that Boston Children’s Hospital has an additional safety step that requires the authorized prescriber to personally approve the IRT dispense to ensure dosage and quantity of the medication is correct.
Navigating eClinical Systems
Bliss said site staff have several clinical systems they must navigate between, including regulatory systems, electronic medical records, Vestigo, access to passwords, sponsor specific protocols, and others. All staff have individual access to systems rather than general access, which can often cause delays, impacting a patient’s overall experience at the clinical site. Giving an example, Coughlin stated when working with children in developmental medicine, minimizing the time spent on site is crucial. Delays due to access can quickly escalate and impact a child’s wellbeing, transitioning from a manageable situation to a difficult one for staff. All speakers agreed that clear communication is essential when accessing eClinical systems, with Coughlin stating, “Study coordinators need to be notified beforehand to communicate with the pharmacy team effectively.”
Several challenges were highlighted during the fireside chat regarding balancing potential sponsor needs with site processes for critical data in the IRT system. Bliss said that many staff experience issues with access and navigation within the IRT system and having a “comprehensive reference guide” could improve user experience. Also, managing entry of receipt data for different shipments can become difficult, with Bliss suggesting having a feature that allows staff to see specific delivery dates in the system.
Scoville, who spoke about usernames and access management, said that it can be “overwhelming at times.” As an example, he said, “I’ve got 14 active protocols using one system, and every protocol has its own username. So that’s one system with roughly 275 active protocols.” Having a single sign-on feature or unified account protocols could streamline access, especially when managing multiple protocols and systems simultaneously.
Scoville also discussed instances where power shutdowns affect refrigerators and freezers, leading to temperature excursions and disrupted operations. He proposed that an IRT system should be able to facilitate the handling of these situations by allowing streamlined documentation, quarantine management, and direct communication with sponsors. This would ease the burden and workload on study coordinators and improve overall clinical site operations, he stated.
CPAP Order Bills Alongside IRT systems
The panel also focused on the integration and alignment between CPAP order bills, IRT dispensing calculations, and treatment allocation.
Jerome outlined the process used at Boston Children’s Hospital, who’s “goal is to get everything on CPAP.” This is to ensure accurate prescriptions and avoid discrepancies that could impact patient treatment and billing processes. Differences in dispense quantities or doses calculated in IRT — not matching with the CPAP prescription — can result in delays and inaccuracies in the processing. Jerome emphasised that communication between pharmacy staff is essential when comparing the IRT printout to the CPAP prescription. “We can’t move forward until we all agree,” he said. Real-time coordination and early knowledge of IRT outputs are essential to streamline prescription processing and avoid last-minute adjustments or delays.
Optimizing IRT System Training
The speakers also discussed training for IRT systems, and the ways in which it can be improved for clinical site staff. Challenges associated with IRT system training include time-consuming sessions, access requirements, and the need for more role-specific training modules. The panel suggested streamlining the process by implementing standard operating procedures where only one person undergoes extensive training and then trains others.
Scoville expressed the need for self-paced training modules and creating tailored content for specific departments. Clinical site staff are often inundated with their day-to-day role, so saving time and improving efficiency with training is a priority, he said.
Additionally, Coughlin proposed improvements to certification access. Enabling easy access to training certificates within the IRT system for users or administrators would ease the process of providing necessary documentation directly, she said.
Overall, the fireside chat provided a comprehensive overview of the IRT system from the perspective of clinical site staff. This included expert insights into the successes of implementing IRT and eClinical systems, as well as site staff challenges and potential solutions that could enhance patient experience.
