Doctors will tell you that change – any sort of change – is hard on humans. As endocrinologist Hans Selye observed, “Stress, in addition to being itself, is also the cause of itself and the result of itself.” Good changes and bad changes alike elicit stress points on psychological scales.
Most clinical trial Project Managers will say the same thing applies to managing changes in clinical studies – especially those that impact data systems (e.g., EDC, IRT/IVR/IWR, etc.)! This includes configuration changes, protocol changes that require changes in how a technical system functions, data changes, process changes…and more.
“There are five components to any successful system change,” says David Goldston, Managing Director of Veracity Logic, an IRT provider. “First, a clear statement of the change is required. This isn’t as easy as it sounds, interpretive communication being what it is. Spend the time up front to confirm with all stakeholders the correct wording of the change. Misinterpretations can cost more in time and money than the change itself.
“Second, cultivate partners whose project management and technical teams pride themselves on offering creative solutions to study problems – there’s often more than one way to implement a change. A capacity for good dialogue between all members of the study team reaps great rewards.
“Third, ensure that the lines of authorization in the study are clearly established and adhered to by all team members. Obtain written confirmation from the person(s) designated at study startup as authorized to order the change.
“Fourth, ensure that a suite of adequate quality controls are in place for proper implementation of the change and to capture and address any unexpected consequences of the change.
“And five, ensure that technical audit trails and your document repository together constitute a clear, re-claimable information trail pre and post change.”
Veracity Logic’s approach to change management has evolved over more than a decade of deploying global IRT systems, and more than 30 years of clinical trial oversight for major CROs. Be sure to stop back next week for details in The Art of Making Changes Part 2: Focus on Process !
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