According to our research less than one third of sponsors think that they are archiving their eTMF in adherence to archiving regulations. The complex regulatory landscape has led to misconceptions and uncertainty among sponsors on how best to approach compliant archiving and preservation.
As a sponsor, you are accountable for the effective archival of the eTMF. If mistakes are made, then it is your organisation who will be liable for fines, delays to the drug development process and any related reputational damage.
Our new eTMF Archiving and Preservation Guide has been designed to provide an introduction for professionals involved in clinical trials to the basics of the long-term preservation of the eTMF.
Throughout the eBook we’ll guide you through the eTMF archiving and preservation process, covering topics such as;
- Why digital preservation differs to a normal backup
- Misconceptions on eTMF archiving
- eTMF archiving regulations
- Best practice approaches to data management
- When to start planning for the archival of your eTMF
- Considerations when outsourcing archival to a third party
- The value of eTMF archiving beyond compliance.
Essentially, we outline how to achieve an inspection ready eTMF, the questions you need to ask and the considerations you need to make to ensure compliance with both regulations and data management best practice approaches.
You can download the full eBook for free by completing the below form.
23 Sep, 2020
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