Coordinating effective contingency training plans
Tuesday, May 30, 2017
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
The call to participate in clinical research is transforming for patients, practitioners and research staff. Effectively executed drug studies can result in life changing therapies that level the playing field of human illness.
A successful clinical trial demands the extreme dedication of the personnel involved. Research patients accept the risk in that a investigational therapy may advance, hinder or stall disease treatment. Research investigators and staff work tirelessly to promote patient safety, regulatory standards and integrity of study conduct. CRAs and data managers scrupulously review the study data to ensure the accuracy of the information that will ultimately comprise part of the FDA submission. Each contribution, no matter how small, is impactful because it influences drug development, reporting credible data regarding the disease state and what is working/not working toward a cure.
There is a particular role in clinical research that is pivotal, yet rarely lauded. This position requires extreme finesse for the level of difficulty presented. I speak of the line manager—those who supervise the CRAs and study coordinators (SCs), who provide behind-the-scenes guidance/support so their staff can continue to operate effectively in-house or in the field. They are the advocates, teachers and protectors. They have the largest workload, the least assistance and often their efforts go unrecognized.
I know a CRA manager, Laura, who embodied the dedication required to manage beyond supervision and truly lead. She gave full support instead of rote direction. She assisted her staff through conflict resolution, and, by her example, taught them personal accountability. She inspired her employees to see above the status quo to their next career milestone and encouraged their ambition.
Laura’s greatest success story, and, conversely, her greatest challenge, was a CRA 1 who was placed in an impossible situation until a forced collaboration saved the project and provided an invaluable learning opportunity.
Travis was a clinical trials associate recently promoted to an entry-level CRA position. Though he had several years of SC experience, he was new to the monitoring role. He was introduced to the frantic pace of clinical operations with a new line manager (Laura) and assigned as the unblinded CRA for a phase II study the same week.
Unfortunately for Travis, the study clinical trials manager (CTM) had been terminated prior to completion of the unblinded pharmacy monitoring plan, and, consequently, Travis’ study training. The project manager was located in another country and was scrambling to fulfill both roles until a CTM replacement was identified. The study CRAs were traveling across the country to activate sites and lacked the time to mentor him. Meanwhile, study enrollment was steadily progressing, as was the deadline for the first unblinded pharmacy monitoring visit. Travis was bereft of the focused study direction his experience level demanded. Laura recognized the near hopelessness in his voice as he informed her of his dilemma. She spent several hours trying to resolve this issue and take the unfair burden off his shoulders. Then Laura realized that SHE was the solution.
- Laura had previous experience as an unblinded monitor.
- Laura had previous experience as a lead CRA.
- Laura had previous experience creating monitoring guidelines and training CRAs.
Laura proposed herself, to the project manager, as the unblinded study CTM until a replacement was found. When the project manager learned of her experience, he heartily agreed to the solution. They collaborated on the unblinded pharmacy monitor training materials and completed the unblinded pharmacy manual. Laura completed Travis’ unblinded CRA training and all elements of drug accountability: drug preparation, dispensation, dosing calculation, drug compliance/counts, study blind and the delineation of responsibilities between blinded and unblinded research roles.
As it was the line manager’s responsibility to evaluate staff monitoring visits, Laura accompanied Travis to his first unblinded pharmacy monitoring visit and was able to approve his ability to independently monitor. The dynamic of their relationship provided the most optimal training environment because a strong bond of trust and transparency was created during the problem-solving process.
Laura’s actions ensured that Travis received the training required for his role, and the project met the unblinded monitoring visit deadline. Travis learned critical thinking skills from the individual with the most influence on his professional development and bore witness to her sacrifice on his behalf. It was the most successful outcome for all parties.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She works in relationship development/study startup. Email firstname.lastname@example.org or tweet @ebwcra.
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