Archiving clinical trial data throughout its lifecycle is crucial for maintaining long-term data integrity and meeting regulatory requirements. However, achieving this integrity poses significant risks and challenges, particularly for eTMF records. Effective digital preservation practices are essential for ensuring compliance and enabling future data reuse.
In this session, Matthew Addis and James Markley will provide comprehensive insights into the best practices for archiving eTMF data. As an attendee, you'll learn about the preparation strategies necessary for effective archiving throughout the data lifecycle. We'll discuss the common risks and challenges encountered in maintaining data integrity over the long term. Additionally, we'll be exploring how good digital preservation practices can be applied to clinical data to support both regulatory requirements and the potential for data reuse.
What you'll learn:
- Strategies for better preparation for archiving throughout the entire data lifecycle.
- Risks and challenges of achieving long-term data integrity when archiving eTMF.
- Application of digital preservation best practices to clinical data for regulatory compliance and data reuse.
CHAPTERS
00:00 TMF Week welcome
01:52 Session topic and speaker intros
03:21 Common clinical trial data questions
08:40 Determining a RBA & Example
11:19 the basis of a robust TMF strat & oversight reviews
16:54 Regulations and guidelines
17:48 Long term Retention and use of eTMF / Digital preservation
20:42 A way to think about risk
28:38 TMF and Study Data Standards
32:36 Q/A
44:15 Closing remarks
