clinical trial

As part of a sponsor’s inspection readiness activities, storyboarding is a crucial step that provides a solid framework for addressing challenging or important areas of noncompliance via corrective and preventive actions. With the aid of organizational and risk assessments, sponsor companies should be able to pinpoint issues and utilize storyboards to systematically discuss the implementation of action plans with inspectors as requested during an inspection.

Storyboard Benefits

Utilizing storyboards has various benefits.  The top five benefits include the following:

1. They offer a structure for formulating concise content that the inspection team can convey reliably.
2. They are particularly beneficial in circumstances where an organization has gone through a transition or considerable change, for closing gaps that have already existed, and in other exceptional cases of self-identified compliance.
3. They point out the corrective measures taken to guarantee patient safety and maintain data integrity.
4. They assist in removing ambiguity, potential disagreement, and pressured decision-making while responding to inspection questions about challenging and perplexing clinical trial components.
5. They lessen the possibility of issues occurring during an inspection as a result of several facilitators or SMEs accidentally giving conflicting accounts of what happened, and the steps taken to address associated problems or gaps.

Storyboard Tips

Being proactive and starting development when a problem or situation emerges can save a ton of time and work later on when attempting to put together a summary later. Therefore, it is a recommended practice to generate storyboards as early as possible.

The following are useful tips regarding a storyboard:

• A storyboard should be utilized as a tool to assist the facilitators in making sure that important information is accurately and succinctly communicated, and that those informing inspectors are on the same page.
• The location of pertinent supporting paperwork should be listed on a storyboard so that facilitators can respond to inspection demand swiftly.
• Storyboards should not be lengthy things of the past with background or unnecessary material, but rather brief and to the point. They are designed to contain minimum amount of information necessary to properly respond to an inspection request.
• A storyboard’s content can be discussed verbally with an inspector but storyboards themselves should not be shared or mentioned because they are not meant to be discussed in full during an inspection.
• Storyboards shouldn’t include statements that unintentionally encourage facilitators to disclose information that an inspector might not have otherwise asked, as this could raise further questions and create confusion or ambiguity.

Conclusion

In conclusion, storyboards can offer the foundation required to communicate important information in a clear and simple manner with assurance and in synchronization across all departments of the organization, making the inspection readiness process considerably simpler for all parties involved.

References

Gwizdak , S., & Marshall, M. (2020, December 10). 4 ways to Adapt Your Inspection Readiness Framework in a post Covid-19 World. Halloran Consulting Group. Retrieved August 1, 2022, from https://www.hallorancg.com/2020/06/19/4-ways-to-adapt-your-inspection-readiness-framework-in-a-post-covid-19-world/#:~:text=Storyboarding%20is%20an%20important%20activity,critical%20aspects%20of%20a%20study.

HealthResearchBC. (2020, October 27). Regulatory update: Clinical trial storyboards. Clinical Trials BC. Retrieved August 1, 2022, from https://www.clinicaltrialsbc.ca/regulatory-update-clinical-trial-storyboards/

LifeScienceLeader. (2020). 09.28.20 — bringing clarity to Regulatory Inspection Readiness & Facilitation. 09.28.20 — Bringing Clarity To Regulatory Inspection Readiness & Facilitation. Retrieved August 1, 2022, from https://www.lifescienceleader.com/doc/bringing-clarity-to-regulatory-inspection-readiness-facilitation-0001