News
27-Feb-2020
Updated RAMPART CRFs
We are introducing some new and updated CRFs for the RAMPART study - see below for details. Copies of the new versions can be found in the member's area. The CRF Completion Guidelines have also been updated (v3.0) to incorporate these changes. Please file these updated documents in your ISF and the new CRF versions should be used with immediate effect.
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New CRFs |
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Form 11 |
PI Sign-off |
At our recent MHRA inspection, we were asked to demonstrate PI oversight of all data supplied for our studies. We’re therefore introducing a PI Sign-off CRF which requires our PIs to confirm at key events in patient follow-up (randomisation, end of treatment, progression and death) that they are happy with the data provided up to that point. The CRF does not need to be signed at the time of the event – they can be batched up for the PI to sign when they are available. |
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Form 20 |
New Primary Cancer |
We’re introducing a new CRF to capture some basic information about any new primary cancers that are diagnosed during trial follow-up. This is very important data which will contribute to the study outcomes. If you are aware of any diagnoses for patients currently in the study, please complete the CRF retrospectively. |
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Updated CRFs |
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Form 08 |
Post-Treatment |
We have added a new section to collect details of any non-protocol anti-cancer therapy that has been received. This is specifically aimed at patients who have progressed or been diagnosed with another primary malignancy. |
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Form 10 |
Progression |
We have re-written this CRF based on feedback received to help clarify when progression should be reported. The first page is specifically for the first progression. The second page should only be completed for patients who have had a local progression, but then subsequently |
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Form 13 |
SAE |
The only change to this CRF is in the section completed by the MRC CTU team. There is no change in the data being collected by sites. |