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
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