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
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
Enrollment Options
Tags: Business Process Mapping (BPM), Trial Master File (TMF), Electronic Trial Master File (eTMF), FDA Compliance, Clinical Trials, Regulatory Inspections, Data Integrity, FDA Guidelines, Document Control Systems, Process Efficiency, Carolyn, Troiano, September 2024, Webinar