Planning your TMF Migration
Before we discuss the steps of the migration plan, the first and foremost aspect to plan for is choosing your CRO in the first place.
CRO selection is hugely important and with many factors, you need to think about, such as:
- Experience of indication (e.g. headaches, insomnia)
- Countries they have worked in before
- Knowledge of sites
- Location of team
- Price for the service
- And so on...
So, what questions should you ask your CRO?
A simple 3-step planning process for creating your TMF migration
Step 1.
Have a plan for accepting the TMF before the study ends.
Step 2.
Discuss internally who will be retaining that data and who will be responsible for it.
Step 3.
Research and review any relevant regulations*.
What should your TMF migration plan look like?
Each transfer creates risk.
Having a step-by-step plan will allow you to identify and devise a plan for any risks which may arise.
You should also carry out checks when moving data between each location.
Ask yourself:
- Which areas could cause the biggest risk?
- What checks will you have in place to identify problems before they become too big an issue?
Want to see an example of a basic migration plan?