Migrating your TMF data into an archive
When to start planning for archiving and best approaches for migrating data at the end of the study.
When should you plan to archive your eTMF and clinical trial data?
Diagram 1: When do you start planning your eTMF archiving?
Source: Arkivum's TMF Futures 2020 report
One of the most common questions we’re asked is when the most effective time is to start archiving clinical trial data.
Recent findings from the Arkivum TMF Futures survey show that there are a range of approaches when deciding at which stage of a clinical trial you should start planning the archival of the eTMF (see Diagram 1).
This varied approach is most likely driven by the fact that up until registration it is still possible to plan to archive your eTMF. Additionally, given the relatively recent changes to regulations, many sponsors are still unsure of the most appropriate time to start the archiving process.
From our experience, we would highly recommend planning your preservation strategy from the ground up at phase 1 or even earlier.
Having the right strategy and resulting systems in place as early as possible, ensures that you stay in control and manage your data more effectively from the beginning and throughout each phase of the trial. Early planning can also assist individuals on planning for the long-term management of documents once the study has closed.
Migrating your TMF and clinical trial data
Before you begin benefitting from a digital archiving and preservation solution, you must first migrate your clinical data from your TMF which can be tricky.
First and foremost you need to move the data whilst maintaining its integrity.
To combat comprising your data, having a plan in place to prepare for its migration is essential.
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