Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Overview:

Conducting human clinical trials requires strict adherence to government regulatory requirements, including the storage and maintenance of key documents, content, and images related to the trial. Depending on the regulatory jurisdiction, this data may be housed in a Trial Master File (TMF) or an Electronic Trial Master File (eTMF), which must be meticulously organized and available for inspection by regulatory authorities during and after the trial.

The TMF/eTMF serves as a comprehensive record that demonstrates the sponsor's compliance with regulatory obligations, including the proper management of trial data with integrity. With a vast amount of both structured and unstructured data—such as documents, PDFs, Excel spreadsheets, and more—organizing these materials for a clinical TMF/eTMF can be overwhelming. Multiple stakeholders contribute critical data from various systems, often using differing technologies, platforms, and file formats, making cohesive assembly a complex challenge.

To address this, it is crucial for sponsor companies to develop a detailed technology and data roadmap. This roadmap should outline the types of data that must be submitted, the handling procedures, and the systems for receiving, evaluating, and storing this information. Having such a framework in place will streamline the preparation process and ensure efficiency in managing trial documentation.

A key step in this process is auditing the systems used by each stakeholder to ensure that they are fully validated. Understanding the data formats, reviewing, and approving processes is often overlooked, yet it is essential for ensuring data integrity. Many practitioners responsible for maintaining a TMF/eTMF assume that the incoming data and documents will meet the required standards, only to find gaps later in the process.

Business Process Mapping (BPM) offers a solution by visually representing how these processes function both individually and collectively. It highlights the critical areas that need evaluation and helps identify opportunities for improving efficiency. By defining responsibilities, identifying the systems and data in scope, and standardizing procedures, BPM not only ensures compliance but also reduces duplication and streamlines processes. These process maps can then serve as templates for future trials, fostering continuous improvement and greater stakeholder transparency.

Areas will be covered during the Session:

This webinar will cover the following key areas:

• Business Process Mapping (BPM)
• Business Process Re-Engineering (BPR)
• Trial Master File (TMF) and Electronic Trial Master File (eTMF) background and rationale
• Organizing and maintaining a TMF/eTMF
• Standard Operating Procedures required to support TMF/eTMF activities
• Inspection of TMF/eTMF records
• Structured data, unstructured data and computer systems regulated by FDA
• Computer System Validation (CSV)
• The System Development Life Cycle (SDLC) Methodology
• Risk Assessment
• GAMP®5 Software Categorization
• Q&A

Why you should attend?

Anyone involved in a clinical investigation with responsibility for data, documents, and other artifacts that must be created and maintained with integrity must understand how systems interact, how data flows, and how these critical assets are managed through their entire life cycle. In particular, they are regulated by FDA and must meet all Agency requirements, including those for validation, 21 CFR Part 11, the FDA’s guidance for electronic records and electronic signatures, data integrity, and Good Clinical Practice (GCP).

Whether you are working for a Clinical Trial Sponsor, a Contract Research Organization (CRO), a laboratory testing clinical trial samples, or in any way involved in the mechanics of setting up and managing a clinical TMF or eTMF, you will benefit by learning about how to meet compliance, improve the quality of data, documents, and artifacts, and reduce overall costs.

Business process mapping (BPM) is a very powerful and robust tool, and can help those participating in the process flow to better understand how their part of the process fits in with others. It also shines a light on key areas of the process that may be streamlined or otherwise improved.

What industries will benefit from your training?

Manufacturing and testing companies engaged in FDA-regulated clinical trial activities in the following industries will benefit from this webinar:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs), Manufacturing Operations and Testing Laboratories
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

Personnel in the following roles will benefit:

• Business Analysts
• Clinical Data Managers and Personnel
• Clinical Study Managers and Personnel
• Clinical Trial Sponsors
• Clinical Trial Stakeholders
• Information Technology Analysts
• Compliance Managers
• Laboratory Managers and Personnel
• Contract Research Organizations (CROs)
• Automation Analysts
• Manufacturing Managers and Personnel
• Computer System Validation Specialists
• Consultants working in the life sciences industries who are involved in supporting a clinical trial