Three Approaches to Addressing Study Management Questions

Beth Bieze

Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Operations Strategy and Training Director, ProTrials Research

What Keeps You Up at Night?  

Questions arise constantly in all areas of clinical research. “It’s tough to keep up with all the queries from staff, sites, and other colleagues,” says Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Operations Strategy and Training Director at ProTrials Research. “Questions come in all the time, on topics as diverse as how to handle a conflict at a particular site, how to find an appropriate site in a specific geography, how to handle adverse events or institutional review board (IRB) reporting, or the loss of original clinical trial records. No single person can answer every question, but we can provide pointers on where to look. And once an answer is found, we can archive that in a searchable library for future use.”

“In fact, each of us can motivate and lead our clinical operations colleagues by being a knowledgeable resource,” states Bieze. “Appropriate use of information communications, knowledge libraries, and leadership tools can take teams to the next level.”

As Bieze explains, information communications use a variety of formats, including “did you know” e-mails, sent out weekly to highlight interesting facts that can help people in their day-to-day work. Recent topics in ProTrials’ communications have included “trial-specific information such as what auditors look for when reviewing IRB communications, as well as more general topics such as the improvement in childhood cancer survival rates,” Bieze notes. “Questions on ‘what would you do’ in given situations are also provided, with multiple-choice answers. We also include surveys on our monthly calls, with participant responses shown on screen as a ‘word garden.’ All these approaches help engage the clinical operations team in a fun way, while expanding everyone’s knowledge.”

Knowledge libraries are developed to archive the answers to questions in an accessible digital notebook. These are available for future teams, helping reduce the likelihood that similar issues will recur, sharing new practices that can enable projects to run more smoothly, improving conformance with budgets and timelines, boosting quality, and reducing “negative surprises” on future projects. Additional resources include links to industry-known and accepted, up-to-date websites including those of the U.S. Food and Drug Administration and Transcelerate.

Leadership tools are also shared, including templates for implementation plans, timelines, Gantt charts, project management, and remote meeting techniques. Information is provided on leadership styles (such as democratic, authoritarian, laissez-faire, servant, situational, transactional, and transformational) and leadership skills (such as creating a vision, inspiring others, listening, taking accountability, being humble, communicating openly, and giving others credit).

Study Management Questions that Keep You Up at Night

Join Beth at ACRP 2023 [April 28 – May 1; Dallas, TX], where she’ll break down how to become an invaluable resource to your colleagues AND a huge motivator and leader. View complete schedule. 

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“Used together, these three approaches can help build organizational knowledge, based on an open culture where everyone is willing to help everyone else find solutions,” concludes Bieze.

Author: Jill Dawson