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As clinical research professionals, we rely on the adage, “If it wasn’t documented, it wasn’t done.” This simple concept guides our every effort in creating solid, reproducible scientific progress. However, without effective communication between stakeholders in clinical trials, research sites are doomed to repeat the same (well-documented) mistakes, and study progress can be hindered, shrouded in a fog of confusion and misunderstanding. With that in mind, perhaps the time has come for an addendum: “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!” The flow of communication, from investigative sites through monitors to clients (study sponsors) and to regulatory authorities, must be clearly defined and maintained in order to assure the success of a trial.
Each trial stakeholder owns separate responsibilities, described in federal regulation and international guidance (Figure 1). Per 21CFR 312.50, clients are responsible to “provide investigators with the information needed to conduct an investigation properly,” and to ensure that regulatory authorities and investigators are “informed of significant new adverse effects or risks” with regard to the investigational product. Likewise, investigators are responsible for notifying the clients of “any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug.” Investigators also must communicate regular study progress to IRBs and clients to ensure that an investigation is “conducted according to the signed investigator statement, the investigational plan and applicable regulations.” Finally, the monitor is responsible to liaise between the client and investigator by facilitating the distribution of information from the client to investigational sites, as well as communicating site concerns to the client (ICH CGP E6 5.18.4).
Every trial contains countless moving parts to track and verify, and with clients and investigators maintaining participation in multiple trials at once, it can be easy to lose important details in the shuffle. As a trial’s complexity increases, the potential for miscommunication grows exponentially. The development of a communication plan prior to the start of a trial can help identify key stakeholders, mitigate risk, set and meet realistic enrollment targets, and provide a solid foundation for support with regulatory challenges that may arise. While the development of a communication plan does consume valuable non-billable hours in the early planning phase of trial development, it provides an excellent example of why it is sometimes desirable to “slow down to hurry up.” Without the framework of a finely crafted communication plan, study stakeholders face a silo effect, where an inward focus causes a lack of communication of project goals and progress across stakeholders. An information silo poses the risk of duplicating costly mistakes that can hinder effective study progress.
There are many elements to consider including in a communication plan in order to tailor it to fit the specific needs of the study. An introduction helps focus the purpose and need of the plan, while providing background to the study. It is helpful to include a list of key stakeholders and their roles in study management, as well as areas of responsibility and preferred methods of contact. Next, an action plan should be described, including the type, format, timing and frequency of different communication types; as well as stakeholders responsible for dissemination, receipt and storage of communications. Finally, a process for review and updates should be outlined to allow for analysis of the efficacy of the communication plan and the ability to adapt the plan to accommodate shifting project needs (Mahinda 2006).
However, dissemination of communications and updates is not enough to achieve compliance with good clinical practices in clinical research. Proper documentation of study communication and demonstration of study oversight by investigator and client representatives also are necessary factors. In order to provide a complete audit trail, it is important to consider documentation techniques and types of study communication, as demonstrated in Figure 2. Types of communications might include reports on various topics, such as screening/enrollment, study progress, safety and monitoring. Training documents communicate changes in procedure during study progress. Regular study updates might come in the form of newsletters or study summaries. Informal communications might take place via email or individual phone calls, which can be documented in communication tracking logs. Finally, regular study meetings, such as study conference calls, can be documented with agendas and minutes (Bertram et. al. 2013).
These study communication documents should be stored in the trial master file, with the investigator and the client as described by ICH GCP E6, Section 8. It is a good practice for investigators and other key site staff to sign and date important study communications in order to demonstrate training, comprehension and oversight. Important emails should be printed for long-term access, or at the very least backed up in digital form. While physical security of study communication documents is important, and access should be limited to key study staff and regulatory authorities, back-up access also should be considered. It would be unfortunate if the main study coordinator, project manager or some other key study stakeholder were the sole access to communication documentation, but were somehow unavailable to retrieve documentation in a moment of need.
In a regulatory audit situation, it is important to understand that regulators do not expect sites to execute a protocol flawlessly; rather, they expect that non-compliances will be properly identified, appropriately escalated and adequately resolved. In a well-drafted communication plan, the background of the study and its communication needs will be described, and key study stakeholders identified. Expectations regarding communication types, timing and frequency will be pre-determined so that when challenges arise a framework for well-documented resolutions exists. Auditors will be interested to learn how these challenges were identified and resolved, and study communication documents can provide a valuable audit trail that describes study team efforts.
The flow of communication must be clearly defined and maintained in order to assure the success of a trial. Communication plans may be tailored to fit the individual needs of the trial, and should contain study background information and a description of communication needs, identify stakeholders and responsibilities, and describe communication types, timing, frequency and storage. A communication plan is an important tool in audit readiness, as it provides a framework for well-documented resolution of issues. While it may be desirable in the short term to overlook the creation of a communication plan in order to save time during the early planning phase of the study, without an open flow of communication between investigators, monitors and clients each study stakeholder risks a silo effect, creating redundancy in effort and duplication of mistakes. It is important to remember, “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!”
Bertram, Susan; Graham, Deborah; Kurland, Marge; Pace, Wilson; Madison, Suzanne; and Yawn, Barbara. “Communication is the Key to Success in Pragmatic Clinical Trials in Practice-based Research Networks (PBRNs).” The Journal of the American Board of Family Medicine, September-October 2013, Vol. 26 No. 5.
Mahinda, Tania. “Back to Basics: Developing an Effective Communication Plan for Clinical Trial Management.” The Monitor, December 2006.
21 CFR 312: Investigational New Drug Application
ICH GCP E6: Good Clinical Practice
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Rebecca York, MS, CCRA, is a senior clinical research associate with PPD. She has experience in a variety of therapeutic areas including, but not limited to, infectious diseases, urology and cardiology. A frequent speaker and writer, Rebecca lends her passion for research to training efforts within the research community. Contact her at Rebecca.York@ppdi.com.
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