![]() We all held our breath when the wolf huffed and puffed. She read to us the story of the ‘Three Little Pigs’. I was first introduced to storyboarding in Grade 4 by Mrs. An approach to do this is by using storyboarding to prepare communications. When and wherever possible, keep the order of information consistent. This is crucial to reduce the potential for misunderstandings by the reviewer. Nomenclature, specific terminology, or abbreviations should be consistent throughout. ![]() Language used in the communication should be precise. When a regulatory professional is writing or speaking to a health authority or auditor during a virtual response to on-line questioning or virtual interview, the focus should always be on consistency and clarity to the interviewer(s). Clear, precise, and consistent communication is one of the best tools in team skills toolbox when dealing with the health authorities or independent auditors in helping to describe or explain site risk mitigations and obstacles. Easing the burden of the inspector or auditor by providing clear, precise, and consistent information throughout the virtual visit or via on-line communication is not only good practice for achieving the desired outcome but may also help avoid unnecessary findings.ĬOVID-19 related Shifts in priorities, funding interruptions, unexpected gaps in study data, missed visits, virtual documentation, IP manufacturing delays or issues, as well as changes to the regulatory and industry landscape are all factors that can complicate the development and conduct story of a study. Today’s research team has even less margin of error for poor communication in interactions with health authorities and independent auditors during virtual interviews and simultaneous supporting document reviews. Accurate and consistent communications from team members is important with the onset of virtual inspections and simultaneous supporting document reviews. It presents a new approach, Storyboarding, for site members to draw on to improve the clarity of such communication. This quarter our regulatory article discusses the critical need for clear, precise, and consistent communication on the part of site team members in interactions with health authorities and independent auditors. ![]() Interactions with health authorities require skillful communication.
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