Protocol staff training is a vital, yet not-often-discussed component of clinical research. When an institution and principal investigator receive a new protocol document, the task of updating protocol staff training typically falls on the regulatory staff. This can be a frustrating, drawn-out process that takes valuable time from key team members at your institution. Getting protocol staff members in one location to conduct training is often impossible, and chasing them down individually is an inefficient, challenging process for regulatory staff.
Here are a few best practices to reduce the time it takes to get all necessary staff members trained on the new protocol version:
1. Clearly communicate tasks and deadlines
Upon receipt of the new protocol, send the notification with clearly outlined due dates and requirements of the new protocol training to applicable staff members. This should include dates for review and what specifically needs to be done, along with dates when you will be following up to check in.
2. Closely track staff training progress
Keep a detailed log of who needs to complete a protocol training. This log should include:
- Staff names
- Their roles on the protocol
- Dates the training was sent to them
- Dates they will be reminded of the training
- Dates they completed the training and signed the applicable documentation
3. Develop a comprehensive, yet unobtrusive notification schedule
Ensure you’re sending reminders to your protocol staff at a pre-defined, consistent and reasonable schedule. It’s important your team trusts they’ll be notified for every task that needs to be completed, however, sending out too many reminders can result in staff ignoring the notifications altogether.
4. Make communication a two-way street
In some cases, even if staff have completed training, they don’t alert regulatory staff. Create a process that makes it easy for staff to notify you when they’ve completed the new protocol training, and ensure the process is being implemented across all teams.
5. Identify trends and take action
As discussed above, you should closely track the dates you originally sent out the protocol for training, sent reminders and sent past-due alerts. With this information, you can identify groups that typically complete the training ahead of time, on time or are frequently late. This will allow for additional processes to be put in place for those that frequently miss protocol training deadlines.
Developing a clear plan, and holding your regulatory and protocol staff accountable, will put your protocol training efforts on a path to success. In addition to the steps outlined above, an eRegulatory system can provide efficiencies that centralize and standardize your protocol training process. Solutions such as Forte’s eRegulatory Management System (eReg) let you automatically notify protocol staff of new tasks, and allow staff to electronically sign off that those tasks have been completed, enhancing your workflows and boosting regulatory compliance. To learn more about how eReg can streamline your regulatory processes and sign up for a demo, click here.