Regulated Clinical Documentation And Content – Purpose, Proper Handling, And Metadata

Date: February 28, 2017
Time: 1:00pm-2:30pm, EDT US
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Training Session 1: The first session of this three-part Clinical Regulatory Document Management Compliance Professional (CRDMCP) certificate program will spell out Trial Master Files, electronic Trial Master Files, and the importance of inspection readiness for these critical documents, plus outline regulatory requirements and best practices.

Register now for the entire program at a significant discount!

Learning objectives, key drivers and pain points associated with this session topic: 

  • Overview of the Trial Master File (TMF) Reference Model – an industry best practice
  • eTMF (electronic Trial Master File) implementation considerations
  • Important aspects of inspection readiness – preparing for any eventuality

Part A - Documents: What are they good for?

Clinical trials are a critical element of drug development. Introducing the investigational products to consenting trial participants under Good Clinical Practices (GCPs) and using the resulting data to support the marketing of a trial are crucial to the study ever happening. The documentation directly related to a clinical trial must be accurate, readable, and appropriately handled. If successful, your trial could result in a Clinical Study Report published as a component of an eCTD (electronic Common Technical Document) with many other documents. For human (patient) protection, this content is regulated. We will review mandates, guidelines, standards and best practices for good document management.

Part B - Site & Sponsor Essential Documents

The Trial Master File (TMF) is comprised of essential documents that drive the conduct of a clinical trial and validate compliance by all stakeholders. We will discuss the content of the TMF as defined by standards and best practices, plus describe the roles of all involved in their creation, management, and retention. Partnerships including CROs and other functional-sourced roles will be considered.

Part C - Regulatory Information Management

Regulatory Information Management (RIM) encompasses the business practices in the pharmaceutical industry involved in the development, capture, dissemination, control, and management of regulatory-focused content throughout the many stages of the product lifecycle. We will assess the business processes, technology tools, products, and service platforms that assure compliance and efficiency. Regulatory influences driving the increasing amount of data to be collected and provided to the regulatory authorities – and standards like XEVMDP or IDMP – will be discussed.

Part D - Looking Forward: What regulations, standards and industry trends are underway and/or anticipated?

There are a number of recently released and upcoming regulations, regulatory guidelines, standards and industry trends.  We will briefly outline these and what their impact has been and could be going forward.

Examples: ICH GCP E6 Revision 2, Status of IDMP Standard

This session will be valuable to clinical trials and associated/related personnel looking for a foundational understanding of Trial Master Files (TMF), electronic Trial Master Files (eTMF), and inspection readiness.  Anyone who needs or wants to be conversant in these areas will find this course highly useful.

Betsy Fallen is an authority on the business processes and associated use of information technology in drug development. A passionate advocate for moving life sciences business on-line, Betsy is an expert on IT in regulatory and clinical operations, data management, and ancillary supply chain, among other areas.

Betsy recently left Merck after two decades of outstanding contributions. She has participated in many industry initiatives including DIA Communities (including TMF Reference Model) and eRegulatory & Intelligence and Annual Meeting Planning Teams; IRISS Global Submissions Operations Group and FDA-PhUSE Site Selection Working Group.

Currently, Betsy is an Independent Consultant providing expertise to industry. She is an active member of DIA and frequently participates in conferences and meetings as Program Chair, speaker, or session chair. She has also presented globally on diverse topics in clinical and regulatory areas for many conferences.

Daniel F. Orfe is a Leadership professional with 20+ years experience in Regulatory eSubmission production and 30+ years experience in support of the Life Science industry. Presently managing Regulatory eSubmissions LLC, providing subject matter expertise focused on "cloud-based" eCTD and EDMS solutions. Dan is recognized within the industry as an executive level change agent and business process analyst for efficient submission assembly, dossier management and eCTD/eCTD life-cycle production.

He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency. Valued for his experience on the topic of eSubmissions, Dan has presented or chaired sessions at 11 of the past 14 DIA Annual Meetings and was conference co-chair for the DIA Electronic Document Management (EDM) Conference in 2009, 2010 and 2011. Dan presently serves as a program committee member for the DIA Regulatory Submissions, Information, and Document Management Conference (RSIDM).

Dan was responsible for the establishment and management of eSubmission production groups at Merck & Co., Inc. and Datafarm Inc. Areas of expertise include regulatory submissions strategy and business / technology process improvements; uniquely adept at identifying innovations which facilitate the automation of activities for efficiency and error reduction.

Dan established and managed the Electronic Submissions group at Merck. This group of 10 people located in the US, Canada, EU, and Japan produce over 300 eCTD/eSubmission deliverables per month. Merck’s achievements within this field established the team as an industry direction setter and submission delivery record setter. Dan oversaw Datafarm's Regulatory Services Group; directing the company’s electronic submission publishing and management activities; and providing strategic support for the further expansion of Datafarm's Submission Services. At Teva, Dan oversaw the harmonization of worldwide electronic submission publishing and document management. At Radius Inc., Dan was responsible for eCTD and EDMS activities, processes and tools.