Examining the data retention requirements of EU Reg 536/2014
Watch the recording of the session below
As we approached the first anniversary of EU regulation 536/2014 coming into effect, Arkivum hosted a webinar breaking down the key long-term data retention requirements…and most importantly, what they mean for clinical trial sponsors and partners.
Tom Lynam (Marketing Director) was joined by Arkivum CTO and digital preservation expert Matthew Addis to provide answers to important questions such as:
- How long must the trial master file be retained for?
- Should I have a dedicated digital archive?
- Who is responsible for archiving the data?
- How do you ensure that data is readily available and accessible?
- What must I do to guarantee long-term legibility?