Guest Column | June 6, 2024

Storyboarding: The Secret Weapon Of GCP Quality Assurance

By Donatella Ballerini, GCP Consultant

Project Planning-GettyImages-960180834

The first time I heard about storyboarding was during my university days. One of my roommates was studying graphic design and visual communication, and she was often busy drawing extensive storyboards for her exams. I envied artistic exam preparations compared to my lengthy and sometimes dull study books, and I found the concept of storyboarding incredibly enlightening. Although storyboarding is typically associated with visual storytelling in film and advertising, this tool is now gaining traction in clinical trial management.

Years later, of course, I have started to use storyboarding in GCP quality assurance. Some of you might wonder how a tool used in movies can be relevant to clinical trials. Let's start by considering the complexity of clinical trials, where every detail holds immense significance. Ensuring transparency, clarity, accuracy, and consistency in communication is crucial. The journey from drug development to regulatory approval involves numerous events, challenges, and pivotal moments that shape the narrative of each trial. In this intricate context, the art of storyboarding can emerge as a powerful tool for GCP quality assurance.

From Show Biz To ClinOps

Rather than depicting cinematic scenes, storyboards can convey the essence of a trial's development journey, providing clarity when the clinical narrative becomes very complex and difficult to understand and/or share. Clinical trials aim for high quality, but since humans manage them, issues can arise. Some are minor and easy to fix, while others are more significant and require extensive corrective and preventive actions. Additionally, explaining these issues during inspections can be challenging. This is where storyboarding becomes an invaluable tool, facilitating effective communication not only during inspections and audits but also during handovers and among study team members.

Storyboarding also aids in communicating deviations and corrective actions. When unexpected issues occur, the storyboard can highlight these events and outline the steps taken to address them. This transparency builds trust and ensures that stakeholders are fully informed about the trial’s progress and any challenges encountered. Furthermore, storyboarding supports interactive and collaborative discussions. Stakeholders can provide feedback directly on the storyboard, fostering a more engaged and informed dialogue. This collaborative approach ensures that all parties clearly understand the trial history and can contribute to decision-making processes effectively.

In summary, storyboarding enhances the communication of a complex trial by providing a clear narrative that is easy to understand and engage with, ensuring that stakeholders are well-informed and involved in the trial’s progression, to be ready when an inspector from a regulatory body or an auditor knocks at the door.

Making Storyboarding A Part Of The Plan

The genesis of a successful storyboard lies in its narrative architecture. It begins with a statement acknowledging the company's proactive identification of gaps or issues, setting the stage for transparent communication. Succinct summaries of the identified issues, accompanied by timelines and background information, form the backbone of the narrative. In my experience, I have never seen a clinical trial without quality issues or exceptions to be managed. Things happen, and a proactive approach can make a significant difference.

“Quality in clinical trials is not only about the absence of errors but also about developing the most effective corrective and preventive actions to address them when they do happen.”

Quality in clinical trials is not only about the absence of errors but also about developing the most effective corrective and preventive actions to address them when they do happen. Some issues can be just accidents that happen during the complex journey of a trial; some others can be recurring issues that are generated by a lack of knowledge and by missing processes. Performing a root cause analysis is crucial to better define an effective Corrective and Preventive Actions (CAPA) plan, but some issues are more complex than others. In some cases, more than one function is impacted, and the resolution can require effort and input from several stakeholders (both internal and external). And because each stakeholder has its own perspective and approach to the issue, it’s important to ensure that everyone is on the same page and that the final message to auditors and inspectors is equal, avoiding misunderstanding and further investigations.

Storyboarding significantly supports the development of corrective and preventive actions in GCP quality assurance by providing a structured and visual framework to analyze issues and provide solutions. The process begins with identifying deviations or non-compliances, allowing for a clear and immediate understanding of the problem. By mapping out the sequence of events leading to an issue, storyboarding helps in pinpointing the root cause. For example, if a deviation in data collection occurred and was identified, the storyboard can highlight the steps taken during that phase, putting under light where the process failed. This approach makes it easier to analyze and understand the underlying causes of non-compliance.

A very important process in GCP requirements is informed consent. Direct impact on patient rights and data integrity so everything must be very smooth. Unfortunately, because that process occurs at the site level, issues are very common. Some of them are easy to fix and can be done during monitoring visits; some others can be more complex requiring more attention and a better strategy for effectively managing them. Think about a sample or an analysis taken in a country where per local requirement it was not allowed, despite the consent given by the patient. Consider the impact at different levels and from different perspectives, not only GCP but also regulatory requirements, from different stakeholders involved in the resolution, and with the impact assessment. These are all good ingredients for developing a helpful storyboard! (Here’s a sample storyboard to put it into perspective.)

Once the root cause is identified and understood, storyboarding facilitates the development of corrective actions. These actions are developed on the storyboard, detailing the specific steps required to address the issue. This clear depiction ensures that all team members understand their roles and responsibilities in implementing the corrective actions. Moreover, storyboarding is invaluable in planning preventive actions to avoid the recurrence of the issue. By visually mapping out the modified processes and incorporating the lessons learned, it ensures that preventive measures are clearly documented and integrated into the trial’s workflow. The dynamic nature of storyboarding also allows for continuous monitoring and updating of CAPAs. As corrective and preventive actions are implemented, the storyboard is updated to reflect progress and any further adjustments needed. This ongoing process ensures that CAPAs are not only effectively executed but also continuously improved.

Storyboarding For Risk Assessment

Storyboarding is also a valid tool that can be used during the important activity of risk assessment: at the beginning and during the clinical trial, study teams attempt to identify all potential risks that can occur during a clinical trial and develop mitigation actions to prevent disasters. While some risks are predictable, others are not, such as the unforeseen COVID-19 pandemic. In such extraordinary circumstances, teams deviated from standard processes, established new plans, and developed numerous mitigation actions. Years later, providing a rationale or a coherent story for these actions can be challenging or nearly impossible due to personnel changes, differing memories, and fragmented documentation. These situations are ideal for developing a supportive storyboard.

Creating An Effective Storyboard

To tell an accurate and consistent story during an inspection, your storyboard must also be well-crafted. Developing an effective storyboard for clinical trials requires a systematic approach to ensure clarity, consistency, and relevance. Here's a step-by-step guide to creating a comprehensive storyboard:

  • Identify the purpose: Before diving into the storyboard creation process, clearly define its purpose. Consider the multiple potential scopes it could encompass, such as trial milestones, compliance documentation, or key performance indicators. Having a clear purpose will guide the content and structure of the storyboard.
  • Establish a team and facilitator: Assemble a team of stakeholders who will contribute to the storyboard development process. This team should include clinical operations personnel and representatives from other relevant departments when needed, such as pharmacovigilance, regulatory affairs, and quality assurance. Designate a facilitator to lead the storyboard development meetings and ensure all perspectives are considered.
  • Establish the best format: There is no standard template for storyboarding; they can be a PowerPoint presentation, a Word document, or even an Excel spreadsheet. The format depends on the goal of the storyboard and on the type of audience you need to reach. (I always use Word and PowerPoint).
  • Utilize references: Draw upon existing documents and resources to inform the storyboard's content. References to documents such as the Trial Master File plan, study agreements, standard operating procedures, and study plans can provide valuable insights and ensure accuracy and consistency in detailing trial activities and compliance measures.
  • Define the development process: Establish a clear process for developing and maintaining the storyboard to uphold quality and consistency. This process can be outlined in a simple working instruction document, detailing the steps for storyboard creation, review, and updates. Ensure that roles and responsibilities are clearly defined to facilitate efficient collaboration among team members.

By following this step-by-step approach, you can develop a TMF storyboard that effectively communicates trial progress, compliance measures, and key insights to stakeholders across the organization.

Overcoming Challenges In Storyboarding

At this stage, you might think that storyboarding is the tool you were looking for to convey clear messaging to inspectors, facilitated by the sponsor's team. However, even seasoned industry leaders may encounter challenges in developing dynamic and comprehensive storyboards. These challenges often are linked to the complexities inherent in clinical studies and the need to articulate them succinctly, ensuring alignment, understanding, and support across all stakeholders.

Here are some common issues encountered when creating storyboards:

  • variation in approach due to different intended uses
  • lack of standardized types or templates
  • absence of processes and tools described in standard operating procedures (SOPs), as they are considered internal best practices rather than regulatory requirements
  • difficulty in reaching a consensus and articulating the message clearly
  • lack of official guidance on storyboard development
  • insufficient expertise and improper utilization of resources

While developing storyboards may pose challenges, the benefits become evident when the goal is clear. Before embarking on the storyboard process, carefully consider whether it is necessary for achieving quality and inspection readiness. Understanding the specific needs and objectives of the storyboard to be developed will guide the decision-making process and ensure that resources and time are allocated effectively.

Storyboards in GCP quality assurance and in general in clinical trials serve as a framework for crafting clear, consistent messaging that resonates across inspection teams, ensuring that the intricacies of a trial's evolution are conveyed precisely and coherently. In essence, storyboarding transcends its origins in visual storytelling, emerging as a potent tool for GCP quality assurance in clinical trials. By transforming complex narratives into coherent messages, storyboards elevate inspection readiness to an art form, ensuring that the saga of each trial is revealed with clarity, transparency, and compliance.

Download a sample storyboard template developed by Donatella Ballerini here.

About The Author:

With 16 years of experience in the pharma industry, Donatella Ballerini first gained expertise at Chiesi Farmaceutici in the global clinical development department, focusing on clinical studies in rare disease and neonatology. Later, in the global rare disease department, Donnatella served as a document & training manager, where she developed and implemented documentation management processes, leading the transition from paper to eTMF. In 2020, Donnatella became the head of GCP compliance and clinical trial administration unit at Chiesi, ensuring all ClinOps processes complied with ICH-GCP standards and maintained inspection readiness. In 2021, her passion for trial master file (TMF) took her to Montrium to become the head of eTMF services. Donnatella also helps pharmaceutical companies in QMS implementation and process improvement as an independent GCP consultant. Donnatella has been a member of the CDISC TMF Reference Model Education Governance Committee since 2023 and the CDISC Risk White Paper Initiative since 2024.