Changes to a live eCRF

As mentioned in the ‘The importance of User Acceptance Testing and what is required from the customer’ blog, thorough UAT is important to ensure minimal changes are required once the eCRF is live, sometimes this cannot be avoided. Protocol amendments are the most common reason for a Post Live Change (PLC) and this is something that is usual throughout the lifespan of a trial. A change to the protocol can ultimately affect the specifications the study was original built to and therefore changes are required.

The following steps will take you through the PLC request process at Datatrial:

  1. A request for a PLC is sent in to the Datatrial helpdesk. The PLC can be in any form, a list of items in an email, a completed PLC document, etc.
  2. Datatrial review the PLC, liaising with the customer to clarify any requested changes, including reviewing specification documents for changes where necessary.
  3. Datatrial produce and issue a quote for the costs of the PLC.
  4. Customer liaises with Datatrial and confirms cost approval.
  5. Datatrial code and test the PLC, including updating Datatrial controlled study documents and specifications, if required.
  6. Once Datatrial testing is complete, a UAT system is released to the customer for review.
  7. The customer reviews the UAT system and provides a finalised list of issues or further changes required
  8. Datatrial code and test any required changes and release an updated UAT system.
  9. Once the customer confirms that the UAT has passed, Datatrial issue a change control (CC) for customer signature, to authorise making the changes to the live system.
  10. Datatrial review, quality approve and implement the customer approved CC in the live system and up-version any updated Datatrial-controlled study documentation.
  11. Datatrial confirm implementation of the PLC and provide any updated documentation to the customer.