Are you pulling your hair out trying to engage and manage your clinical study safety committee members? If you struggle to coordinate meeting logistics with busy physicians located across the globe, suffer through lengthy and unproductive meetings, or have difficulty interpreting committee records, we have solutions. In this blog post, BRIGHT’s “Safety Sisters,” Joan Hazen and Mary Ovick are real-life sisters who keep the hair pulling to a minimum and share their tips on how to keep these essential study contributors engaged and effective.
Overview of Safety Committees
Comprised of independent, non-investigator physicians, safety committees play an essential role in your clinical study. Depending on the specific type of committee (e.g., Clinical Events Committee, Data and Safety Monitoring Board), they may systematically review and adjudicate adverse events or provide overarching recommendations for study continuation.
Safety committees function throughout the study, and effective management requires both thoughtful planning and ongoing attention to detail. From establishing expectations to keeping members informed, as well as managing all of the meeting logistics, we hope the numerous tips below will prove as beneficial to you as they have been to us.
1. Establish clear expectations in written documents
Expectations for committee members should be clearly defined in writing, and two levels of documentation are usually required. First, execute an individual written agreement or statement of work with each member. Next, create a committee-level adjudication guideline or charter. While this is not a regulatory requirement, we recommend getting approval on this committee document from each member as their signature is an attestation that expectations have been communicated.
The guideline or charter serves as a standard operating procedure for the committee. As such, it should describe membership composition, roles and responsibilities, the specific type of safety data that will be reviewed by the committee, and procedures for meeting logistics and the creation of records. Remember that the committee chair will often have additional responsibilities, so ensure these expectations are clearly documented in the appropriate contract or charter.
2. Use proactive and robust communication tactics
Safety committees are typically established when final regulatory or site approvals are received (i.e., FDA, IRB, CMS) and the first study sites are activated. Rather than scrambling at the last minute, proactively establish your committee and prepare members for action by training them on the guidelines or charter, as well as the study protocol and case report forms prior to the first enrollment. If a study database will be used, provide adequate training and reference tools.
One of our best Safety Sisters communications tips is to request contact information for each committee member’s administrative assistant and ask if it is okay to copy this person on study communications and requests. These wise support staffers have insight into physician’s clinic and personal schedule, and they can be a huge help in securing a meeting appointment or a signature.
Depending on how quickly sites can begin enrollment, some time may pass between training and committee activities. In the meantime, share timely updates about approval status, bursts of activation and enrollment activity, and estimates about when you expect safety data to be available for their review. This communication keeps the members engaged with your study and at-the-ready when it’s time to schedule their review.
3. Provide thorough and well-organized meeting materials
Your safety committees may require different meeting materials, depending on their responsibility. Whether they need to review individual adverse events or trend data, all meeting materials should meet these criteria:
- Complete (e.g., no pages or subjects/adverse events missing, all expected data tables, validated reports, and redacted source documents provided)
- Accessible (e.g., email attachments are in a format that all members can open, database or server log-ins are operable)
- Logical (e.g., review binders include a Table of Contents with sections separated by tabs or digital bookmarks, subjects are presented in numerical order, adverse events are presented in chronological order along with corresponding CRFs and associated source documentation; adjudication processes (especially if electronic) are optimized for efficiency).
We Safety Sisters have preferences in our work styles, and we’ve found that busy physicians are most efficient when we support their work-style preferences. For example, we ask if they prefer paper vs. electronic review binders. While some like to flip between tabs and keep notes in the margins, others depend on the PDF search functionality. Some like to have both options available. Strive to meet the needs of each member and provide the materials well before the meeting to allow ample time for review and to accommodate scheduling conflicts or technical difficulties.
4. Maximize meeting efficiency
It can be quite a juggling act to facilitate fast-paced, highly technical discussions with physicians. We recommend assigning at least two study members, and preferably three, to support these meetings. The recommended roles are as follows:
- Facilitator – supports member discussions and adherence to the agenda
- Recorder – takes meeting minutes
- Data retriever – navigates reference materials (e.g., protocol, database) to support committee requests for additional information
Remote meetings are common and expected for safety committees, and we have a few tips regarding these logistics. First, support your members by using meeting systems that do not require users to download an app, as this extra step may delay the start of your meeting. If that isn’t possible, tap their trusty admin to square away the technology in advance.
Also, it’s helpful if your chosen meeting system allows recording as this provides a useful tool to ensure accuracy of the meeting minutes. If you use this option, remember to inform attendees that the meeting will be recorded. Another handy tip is to have the minutes recorder regularly jot down the time of each adverse event adjudication. This is especially important when complex or lengthy discussions occur during the meeting, so you can quickly reference select portions of the recording.
While we haven’t tried these recording methods yet to confirm who wins our family “adjudication decisions,” we can assure you the techniques work great for safety committees.
5. Ensure consistent and accurate data and meeting records
Consistency is a critical factor to ensure accurate and meaningful safety data analysis and trending. Leverage your electronic systems to identify and investigate discrepancies and similar scenarios that were adjudicated differently across various subjects or timepoints. When an apparent data inconsistency is discovered, offer the results of this investigation to your safety committee, and provide an appropriate place to record any necessary corrections. Look for critical data points the site has changed after adjudication and re-adjudicate if necessary.
Meeting minutes should accurately summarize the essential discussions and decisions. It’s helpful to have an “action item” section that lists clearly defined action items, the specific person responsible, and a due date. Have the committee chair approve the meeting minutes and use a tracking tool to stay on top of open action items. Consider filing the tracker in a shared location so study team members can have up-to-date knowledge of the safety committee status.
Considering the essential role of your clinical study safety committee, it’s important to ensure it functions efficiently and effectively. Your diligent efforts will not only minimize your own stress, but more importantly, optimize outcomes for patient safety and study success. While we Safety Sisters might have a slight advantage in that we are truly family, we’re confident these tips will help your safety committee feel like a happy, functional work family.