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Several weeks ago on this blog, Denise discussed the use of storyboards as a means of “provid[ing] a narrative arc to a messy series of events.” Meanwhile, in this article in the Clinical Leader, Penelope Przekop notes that storyboards “provide a framework for creating clear messaging that can be consistently communicated by the inspection team.” And Jean Smart of Clinical Trials BC says, “The purpose of a storyboard ... is to act as a quick reference to avoid additional inquiry or the necessity of extrapolation on a topic.”
Given the central role that storyboards have come to play in GCP inspections, Synclinical is pleased to announce full storyboard support in Ready Room! This feature further cements Ready Room’s position as the premier GxP inspection management platform. Here’s a quick overview of the storyboard functionality now available.
Let’s dive in.
Storyboards are associated with an inspection. You can access storyboards via a new button in the upper right hand corner of the main inspection board; the one with the speech balloons icon. From the storyboard index screen you can see all of the inspection's storyboards, as well as create, edit, rehearse, search, convert, and print them.
The New Storyboard dropdown menu lets you create a single storyboard using the template associated with the selected category; one of process, problem, or role or responsibility. For instance, the process template will prompt you for information regarding process triggers and steps, while the problem template will elicit information about the quality cycle for identifying and remediating deviations from a regulatory requirement.
It is with the Initialize with Expected Questions menu item, however, that we are able to bring to bear Synclinical’s deep understanding of the BIMO process and regulatory inspections. From this screen, you are able to import any or all of nearly 100 templates covering the questions you can most likely expect to receive during an inspection and the best way to structure responses. This helps dramatically in making sure you are able to provide a crisp and concise answer that completely addresses the issue at hand.
When creating a storyboard you must provide a title and optionally provide a category, protocol, or site. Of note, Ready Room provides a complete and intuitive rich-text editor for creating the body of the storyboard. Once a storyboard is created or imported, you can upload supporting documentation (exactly as you would with an inspection request), add labels (again, as you would with requests), and assign the board to one or more team members (notifying the assignee by email).
Ready Room offers an intuitive and attractive solution for assignees to practice responding to questions using storyboards: flashcards. Flashcard support renders storyboards as flippable cards that slide in from the left or right. Initially, only the title is shown, but clicking the card will cause it to flip over and expose the description. You can cycle back and forth through the deck using UI elements or the keyboard.
When an inspector asks about a topic covered by a storyboard, it is not necessary to create a new request from scratch and re-upload the supporting documentation. You can instead Create a Request directly from the storyboard. This tight integration with Ready Room’s inspection management component causes a new inspection task to be created and opened for immediate editing. The storyboard’s title, assignee (if there was one and only one), labels, and files are copied over to the request. Note, that file copying happens in the background, if there are many files or if the files are large, you will see them appear as each copy succeeds.
It’s not unusual to have 50, 100, or even more storyboards per inspection. For this reason we have implemented intelligent filtering and search. Using the controls across the top of the main storyboard screen, you can filter storyboards by category, assignees (plural), labels (also plural), and content. (If you use more than one filter, they are joined by an “and” condition.) The content filter is particularly interesting as it implements ranked full text search. Full text search ignores English “stop words” and understands stems, so that searching for “the investigator” will ignore the article “the” and find storyboards containing investigators, investigate, investigation, and other variations, with the most relevant storyboards ranked higher. AND (the default), OR, NOT, and quoted phrases are supported.
Finally, it is of course possible to delete storyboards, print them (one per page), and save them as PDFs.
We are very excited about providing our customers with support for storyboards and believe it goes a long way towards providing a complete inspection readiness solution. If you’d like to see more, please contact us at email@example.com.