6 Ways to Reduce Protocol Deviations in Clinical Trials with StudyTeam Technology

Protocol deviations are a common challenge in clinical trials. One study by Tufts Center for the Study of Drug Development reported an average of about 75 protocol deviations per Phase II trial and an average of about 119 protocol deviations per Phase III trial. It’s paramount that site teams adhere to – and are empowered to easily adhere to – clinical trial protocols. Protocol deviations in clinical trials compromise data integrity and study results while also jeopardizing participant safety and regulatory compliance. 

Sponsors can help reduce the chance of a protocol deviation by writing site-friendly protocol amendments and by improving clarity in each protocol’s Schedule of Activities. However, technology can have one of the biggest impacts in assisting sites across their clinical trial workflows to support better adherence to protocols. Here are 6 ways StudyTeam technology does this:

• Digital data collection during pre-screening
• Centralized management of trial activities in one system
• Visit schedules with built-in visit window tolerances
• Automated sponsor reporting with real-time data access
• Electronic source data collection post-enrollment with centralized monitoring
• Online learning portal for pre-screening platform

(1) Digital data collection during pre-screening

Digital data collection during pre-screening offers several benefits including easy-to-check-off pre-screening checklists based on I/E criteria, as well as automated alerts that can flag missing information or the fact that a patient has not met the I/E criteria and cannot move into the next phase of enrollment. This increases the accuracy of sites in identifying suitable candidates as early in the enrollment process as possible.

(2) Centralized management of trial activities in one system

When all members of the site team can track participant enrollment statuses in real time, monitor visit schedules, and manage pre-screening data input in one system, they can efficiently coordinate assignments while quickly identifying and resolving any issues such as incomplete tasks. Automated reminders for upcoming visits can also improve timeline adherence – StudyTeam users can easily set email reminders for themselves and their team members when scheduling patient visits.

(3) Visit schedules with built-in visit window tolerances

Errors can crop up when research teams need to manually calculate visit windows per protocol, especially when protocols are complex or go through multiple amendments. With technology like StudyTeam, customized visit window tolerances can be programmed to match protocol specifications, even when sites are managing multiple protocols or amended protocols. In StudyTeam’s Visit Schedule, site staff can effortlessly see the target date, visit window, and a target tolerance for a specific patient’s visit when they are scheduling that visit in the system. Alerts prevent staff from setting a visit time outside of the correct range.

(4) Automated sponsor reporting with real-time data access

Because under-enrollment and over-enrollment can both cause protocol deviations, it’s important for sponsors to be able to see real-time enrollment progress across all of their sites. Not only does this allow them to keep an eye on enrollment numbers and whether participant demographics align with study goals, but it helps them identify barriers to enrollment, such as certain eligibility criteria that are disproportionately impacting patients or specific subsets of patients. It’s a burden for site teams to de-identify patient information and email the sponsor with log updates; that’s why StudyTeam automatically de-identifies patient information input into the system during pre-screening and makes that data visible to the connected sponsor. Sponsors are updated with no extra effort or communication by site staff.

(5) Electronic source data collection post-enrollment with centralized monitoring

Human error during source data entry can cause protocol deviations, which is why eSource solutions are on the rise. eSource in StudyTeam equips sites with pre-made templates that increase legibility while also ensuring all of the necessary data points are collected at the right time in the trial. Additionally, validation settings can flag certain data-entry errors based on preset ranges of numbers.

To accelerate oversight processes, eSource allows remote access so principal investigators can easily provide oversight from anywhere. Not only does this improve workflow flexibility, but PIs can access and review the most up-to-date data across multiple site team members and multiple trials to address any inconsistencies or concerns before protocol deviations become an issue.

(6) Online learning portal for pre-screening platform

Inadequate training on the technology platform designated for managing recruitment, enrollment, and pre-screening data entry can lead to protocol deviations. Online learning portals reduce the burden placed on site staff of having to learn new technology because they can learn at their own pace and on their own time, instead of adding extra calls and meetings into already tight schedules. The StudyTeam Learning Center (STLC) is an online, self-paced training and education portal that quickly walks sites through ways to effectively start using StudyTeam within their clinical trial workflow. No live sessions are necessary and bite-sized content makes learning sessions quick and focused.

Use StudyTeam to prevent protocol deviations in clinical trials 

Every protocol deviation increases workload and therefore site burden. Clinical trial protocol deviations increase patient follow-ups to make corrections, and therefore increase patient burden. They throw off recruitment, enrollment, and treatment phase timelines. And while they’re bound to happen, protocol deviations can be reduced with the use of intuitive technology.