Business Process Mapping (BPM) – Streamlining Management of Data/Records for Clinical Trial from Variety of Stakeholders/Systems

The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial, including managing data with integrity.

Documents contained in the TMF/eTMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval.

Description:

The plethora of data, both structured database records and unstructured data, such as documents, PDFs, Excel spreadsheets, and other key artifacts makes the assembly of a clinical TMF/eTMF a daunting effort. There are many stakeholders sending in key data about the trial to the sponsor. The many artifacts come from a variety of systems based on differing technologies and platforms, and using differing communication protocols and file formats.

In order to be in a position to assemble these cohesively, once received, the sponsor company should prepare a technology and data roadmap. Knowing what must be submitted, how it should be handled, and where the new clinical trial supporting data and documentation should be received, evaluated and stored can provide a frame of reference that will ultimately streamline efficiency in preparing for the onslaught.

For example, it is important that each stakeholder who will be submitting data been audited to find out if the source systems that will be used by them have been fully validated. The specifics about the data and documents coming in should be understood, including the file format and how they were reviewed and approved by stakeholders. When asked this question, most practitioners involved in establishing and maintaining a TMF/eTMF have admitted they did not think about this aspect of oversight. They typically have not taken such a step, and are working under the assumption the data and/or documents will be fine.

Business process mapping (BPM) provides a visual representation to help understand how the functions included work, both individually and in concert with each other. It also helps practitioners understand what key elements need to be evaluated, and in how much depth. Ultimately, it can help identify ways to streamline and improve the overall process for greater efficiency.

In addition to defining the process, those creating the process map(s) should understand who is responsible for key areas of work, what systems, data and documents are in scope. It will provide key information about how communication and transmission of data and documents will be done, and what factors should be considered when defining the ultimate repository for all these artifacts.

Standardizing procedures can provide consistency across all clinical trial processes and help to meet audit requirements. Those procedures or processes within the map(s) that are repeated can be evaluated in order to remove any duplication of effort. There also may be further automation opportunities that have not yet been explored.

Furthermore, the process map(s) can become templates for future trials, tweaking them as necessary. This would provide stakeholders a better view into how their contribution to the trial will be received, used and stored. This might even lead to further suggestions for improvement by them.

Why Should You 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.

Areas Covered in the Webinar:

This webinar will cover the following key areas:

• Business Process Mapping (BPM)
• GxP Data and Computer Systems Regulated by FDA
• Computer System Validation (CSV)
• The System Development Life Cycle (SDLC) Methodology
• Risk Assessment
• GAMP®5, 2nd Edition and Software Categorization
• Validation Strategy and Planning
• Functional Requirements Specification (FRS)
• Design/Configuration Specifications
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• System Acceptance and Notification of Release into Production
• Maintenance and Operational Support of FDA-Regulated Computer Systems
• Policies and Procedures to Support CSV
• Training and Organizational Change Management (OCM) Supporting CSV Activities
• Trial Master File (TMF) background and rationale
• The essential documents to include in a TMF
• Organizing and maintaining a TMF
• Standard Operating Procedure required to support TMF
• Inspection of TMF records
• Electronic TMF (eTMF)
• Q&A

Who Will Benefit:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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