How to plan for a successful end of study transfer

This is it. Part three of the epic trilogy concerning data transfers at the end of your study. If you have stayed tuned and read this series then thank you. If this is your first time reading this collection make sure you check out Blog One and Blog Two.

In this final post, I wanted to cover the overall planning for end of study transfers, rather than the intricate details of migration plans which we covered in part 2. If I were to ask you ‘when should you start planning for an end of study transfer,’ what would you say?

When you hit a specific ending milestone, such as last patient last visit?

How about data base lock?

Maybe even when your contact calls you and says we have everything zipped and ready to go?

My personal opinion is if you wait for any of these triggers then you’ve missed your mark. ‘Success by design’ is a comment we hear a lot and is wholly suitable here.

What to consider when choosing a CRO

CRO selection is hugely important with many factors to be taken into account.

For example, experience of indication (e.g. headaches, insomnia), countries they have worked in before, knowledge of sites, location of team, price for the service etc. Some CROs specialise in indications – or even types of drug.  The list goes on.

But have you ever asked about end deliverables? Enquiring into this at the start removes surprise further into the future.

What should you ask your CRO?

• What systems are they using in-house?
• Which of these systems will make up that end of study transfer?
• What does data look like when it comes out of the system, file types, audit trails, metadata etc.?
• How will they prepare the data?
  • Will it be exported?
  • Zipped and put on a DVD?
  • Will they give you access to the system directly to extract what you need, or do they offer additional services and solutions?
• Will they remove data from their systems after transfer or does the CRO keep a copy?
• What checks will be done on the data before making it available to you?

 
Let’s take the eTMF as an example.

Before data is even provided it would not be unreasonable to get assurances from the CRO that all documents and content have been successfully uploaded to the eTMF and that completion is now at 100%.

You would also expect that any outstanding quality checks or issues have been resolved and that all the content is final. You also need to understand how this will be recorded and what assurances you have that the data has been through these processes.

What should your eTMF data contain?

1- 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.

2- Audit trail

• • 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).

3- 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.

Receiving your eTMF transfer

This stage is often the most challenging.

You’re confident that checks have been performed on the data being transferred. You know what to expect…now you need to understand how you’ll receive that data. And perhaps more importantly, what are you going to do with it?

Without repeating the previous blog posts, you must think about the transfer method.

How can you ensure it remains secure? What should you avoid and what is the most secure, avoid things that leave your control and could easily be lost or compromised like DVDs and USB sticks and try to use direct transfer methods like File Transfers.

Storage of this data should meet the requirements set out in regulations such as the “Clinical trials Regulation EU 536/2014” from the EU, and guidelines such as “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)” from the EMA.

When you are comfortable you know what you need to accept the data what should you expect? Normally this is split into three categories; content, audit trail and metadata.

In conclusion…

There is a lot to think about here and no one expects you to know all the answers upfront.

The most important considerations are:

• To reduce the number of surprises
• Plan for success
• Prevent unnecessary complications.

 
By simply including in the contract that transfer at the end will be made to either you directly or a nominated supplier can give you enough freedom to establish processes as you go. I have heard of some people refusing to transfer data to an archiving solution directly because the contract, signed years ago, said data would go to the Clinical Project Manager. Things like this just add stress to an already stressful time.

I hope you have enjoyed these blog posts, if you want to know anything more about any of these topics, perhaps talk about how to plan for a successful migration or solutions we provide regarding Archive and Preservation of your data please get in touch via our contact form.

Thank you again and take care.