Accountability in Clinical Research “Two Way Street”

imgDavid-Morin“If we hold our employees accountable, we have to hold ourselves accountable,” says industry pathfinder David Morin, MD, RPh, FACP, CPI. As Director of Clinical Research at Holston Medical Group, he’s worked hard with his team to come up with a robust accountability program designed to improve overall performance — not to point fingers.

Working to articulate the difference between “explanation and excuse,” Morin’s three keys to creating accountability stress:

  1. Thorough standard operating procedure (SOP) documents.
  2. Clear delineations of job descriptions.
  3. Computer-verified training of all staff (mentors also play an important role).

Morin, a past winner of ACRP’s “Outstanding Physician Leadership in the Profession Award,” says he devoted 600 hours to training over a two-year period. While it was obviously a heavy time commitment, Morin says it was well worth it. “We have a sponsor audit every month or two,” he explains. “We’ve had sponsors tell us we have the best SOPs they’ve ever seen.” That kind of strong documentation inspires a high level of confidence with sponsors. “Our site visits go well” as a result, Morin adds.

Nearly six years into his program, Morin notes that employee error is the culprit in audit findings “about 95% of the time.” However, he says his aggressive and neutral accountability system finds systemic flaws now and then, because “there might be some wrinkle in a new regulation we missed.” In that instance, training is immediately updated.

Morin’s two-way accountability system leverages handouts, checklists, and decision trees to help employees and management quickly identify and remediate problematic issues. The accountability system is further bolstered by a mentor program–a designated supervisor who ensures and documents that an employee receives the appropriate training. It helps avoid the “no one told me to do that” or “I wasn’t trained for that” excuses, he says.

Morin will be speaking with his colleague, Nichole Skirvin, BA, CCRP, Clinical Research Manager, at the ACRP 2016 Meeting & Expo in Atlanta, Ga., in April.

Learn more about their session, Creating Accountability: A Step by Step Approach.

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