The Art of Making Changes Part 2: Focus on Process

Case Studies, IRT Essentials

Change is a constant in the world of clinical study planning.  In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the components of a successful management process for technical change.

  1. Use an issue tracking system for all requested changes. This enables you to assign and re-assign the issue to different staff as clarifications occur and questions arise between the initial change request and resolution, and to designate closure when all is done.
  2. 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 a key
  3. PM obtains from system developers/configuration managers the hours required for the change, by various personnel, and any concerns/issues.
  4. Proposals/Contracts personnel provide a quote for the change to the client.
  5. When all questions are resolved, a Change Order with full descriptive text and associated time and cost is prepared for client’s written authorization. Here again it is key that the document accurately describe the change(s) required.
  6. Client signs and returns the Change Order.
  7. System developers/configuration managers implement change in accordance with company SOPs.
  8. Changes undergo appropriate testing and quality review, as required by company SOPs. All issues and questions are resolved.
  9. Changes are released for User Acceptance Testing (UAT), as appropriate.
  10. Issues and questions raised during UAT are resolved, retested, finalized.
  11. Client provides written authorization for the new version of the system to be moved into the production environment and the system made available to end-users.
  12. Issue tracking system is updated to indicate the change is finalized and in production. system. Issue is closed in issue tracking system.
  13. Finance personnel are notified for invoicing.
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