Receiving your Data
Now, how do you get the data from your CRO?
Your CRO will have been recording and storing these in a validated system.
Because of these requirements, your CRO will also be providing you with comprehensive audit trails and instant access.
Now they need to pass this data back to you – but in what format and medium?
We’ve seen many times that the thought of how the eTMF data will be transferred from the CRO back to the sponsor is often left until the time comes at the end of the trial when it’s required.
But there are several challenges to overcome for a successful transfer to take place...
Firstly, you need to move the data from its original location under the ownership of the CRO and move it to its final location so that you can accept accountability.
Secondly, you need to do this whilst retaining data integrity and providing evidence of chain of custody.
Thirdly, is to do the above whilst balancing preparations for you next, or ongoing clinical studies.
…this is where having a migration plan comes in useful.
What should your TMF data contain?
Content
The content we are talking about is all the files that were uploaded and stored in the eTMF (think about all those PDFs, Word documents, Excel spreadsheets and emails etc).
You may also receive a second file per piece of content. Why? Most systems convert each file to PDF where it can enable you to view the document in the system, perform OCR and load content as fast as possible. To note, some systems will export both the native file as well as the PDF.
Audit Trails
Each piece of content uploaded should have an audit trail and these should contain all actions carried out on each file:
- When it was uploaded
- When it was viewed
- Who viewed it
- Changes made to the content or the information attached to it.
Every single file should have an audit trail (if you have the native and PDF you will have one audit trail to cover both files as they are treated the same within the system).
Metadata
What is all this content without the metadata assigned to it? Metadata allows us to filter, search, identify and categorise at a level impossible without it.
You’ll usually get a single metadata file that contains everything important from the system with a link to each piece of content so identification is possible.