A Process for Successful Mid-study Changes

Change is a constant challenge in the world of clinical studies, and it can cause both stress and delays. In our last blog, we discussed 5 tips for more effective mid-study changes.

Now let’s look at the components of a successful management process for a technical change from an IRT perspective.

  1. The IRT Project Manager (PM) initiates the case and bears primary responsibility for ensuring that all stakeholders have the same interpretation of the request being made. This is vital. Tip for Mid-study Changes

  2. PM obtains the hours required for the change and any concerns/issues, from system developers/configuration managers.

  3. Proposals/Contracts personnel provide a quote for the change to the client.

  4. When all questions are resolved, a Change Order with full descriptive text and associated time and cost is prepared for the client’s written authorization. It is key that the document accurately describes the change(s) required.

  5. The Client signs and returns the Change Order.

  6. The User Requirements Specification (URS) is updated with the requested changes. The URS is approved by the team.

  7. System developers/configuration managers implement the change(s) in accordance with company SOPs.

  8. The Project Specification (PS) is updated with the requested changes. The PS is approved by the team.

  9. Changes undergo Validation quality review, as required by company SOPs. All issues and questions are resolved.

  10. Changes are released for User Acceptance Testing (UAT), as appropriate.

  11. Issues and questions raised during UAT are resolved, retested, and finalized.

  12. The Client provides written authorization for the new version of the system to be moved into the production environment and the system is made available to end-users.

  13. The issue tracking system is updated to indicate the change is finalized and in production. The Issue is closed in the issue tracking system.

  14. Finance is notified for invoicing.


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