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Working with CRF versions

1. About CRF versions

Within one study on edc2go, you can have more than one CRF version. Versions can be created to update a previous CRF version or in case you need to work with different versions because of protocol amendments or country/center specific CRF requirements.

Workflow:

Study and CRF design in edc2go is set up according to this workflow:

  1. Create your study - for more information, checkout this article.
  2. create the initial version of your study CRF.
  3. The workflow in edc2go is set up in such a way that you can easily switch between CRF design and User Acceptance Testing (UAT).
  4. If your CRF is ready, Publish this CRF and start collecting live study data.
  5. In case you need to make updates to your CRF after publishing or if you need another (slightly different) version, you can create a new version after publishing.

Good to know:

  • A study center can only belong to one CRF version.
  • You can move a study center from one version to another. In this case, all patients and
    all patient data will be migrated into the new version.
  • Data exports will indicate for each data row to which study version this data belongs to.
  • The number of CRF versions that can be created depends on your pricing plan.

2. Start CRF design - Edit CRF

You can build your CRF when you are working with the CRF in Design status. When, at a later stage, the CRF has status ‘UAT’ or ‘Published’, it will not be possible to edit your CRF.


➙ For more information about designing your CRF, check out these articles in topic: CRF design.
➙ For more information about the different CRF statuses, check out this article.

3. Create a new version of your CRF

You can create a new version of your CRF as soon as your initial CRF has status 'Published'.

To create e new CRF version, follow these steps:

  • Go to the 'My Studies' tab and click 'CRF'.
  • Click the green 'New version' button.

  1. Enter a name and version number (required).
  2. Enter a description (optional).
  3. Indicate to which CRF version you would like to base your new version on (meaning you will start with a copy of that version).
  4. Click the '+ Create' button.

The new study version will be created and appears in the existing list of CRF versions.
The new version has status 'Design'.

  • Click the 'Edit CRF' button to work on your new version:

  1. You can work directly in the CRF builder or use your Library.
  2. Use the dropdown to switch between your versions.
  3. Click 'Manage CRF versions' to see the list of CRF versions.

If you have finished your Design and User Acceptance Testing (UAT), you can Publish the new version.


For more information about publishing a new CRF version and possible consequences for your study data when migrating study centers, please check out this article.



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