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When I was in sixth grade, our English teacher made us diagram short stories: exposition, rising action, turning point, and that funny word, denouement. It was a silly exercise, because every child intuitively understands a story's rhythms. Try telling a bedtime story to a small child that lacks one of these elements - you'll get a lot of questions until the child is satisfied that the story has a beginning, middle, and an end.
When I became a sixth-grade English teacher and asked my students to write stories, I discovered something interesting. Sure, everyone can pick out plot holes when they HEAR a story, but when they TELL a story, all bets are off. I graded stories that failed to introduce the main character; stories that rambled; stories with no conflict; stories with no resolution.
I am reminded of those days when I conduct audit interviews. I like to start with a warm-up question, nothing tricky: "What did you do on the study?"
It's sixth grade all over again. Some people forget to name their role; some can't name a single responsibility; some go on for twenty minutes. A few throw in helpful details of significant GCP deviations that occurred.
I've also been in the hot seat. It's hard! Almost everyone needs to practice to deliver an interview response effectively, even to a question as simple as, "What did you do on the study?" This is why I spend so much inspection readiness time coaching people to deliver answers to the simple, expected questions. Interviewees need coaching and practice to hit those story beats that will satisfy the inspector and forestall further questions.
Thus, we view storyboards primarily as a tool to coach interviewees - not supplemental documentation! - and write them at a conversational level.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.