Process Change in Clinical Research

The adoption of new software presents a valuable opportunity to improve internal processes and workflows. It also means asking a large number of people to change their individual work patterns, especially if they are making a transition to paperless processing at the same time. The following tips can help smooth any significant process change.

  • Plan for the primary business users to own implementation, testing and refinement of the new software application.

Front-line staff should be involved in every phase of the project, from scoping to completion. Ideally, the person responsible for configuring the new system will be a business expert who understands the needs of these users and interacts regularly with them.

If another department will be responsible for technical support, the business owners need to work closely with them and maintain a collaborative relationship. There should also be a clear process for escalating user support issues from front-line staff to a technical resource.

  • Get the right people involved early – and take their input seriously.

To be successful, the implementation plan must meet the needs of the primary business users. Who else will spend a significant amount of time in the new system? Include a representative sample of those users in configuring, implementing, testing and refining the new system.

Don’t forget users (such principal investigators and department heads) who may use the system only occasionally. The process steps they will be asked to complete should be as transparent and simple as possible.

  • Recognize that new doesn’t automatically mean better.

Lessons learned from the implementation of various electronic health record systems can be instructive for IRBs as well as clinical trials offices. An article on the American Medical News website notes that electronic recordkeeping can improve the quality and thoroughness of documentation. One significant downside is that efficiency is not necessarily improved, and added steps and complexities can be a source of frustration.

Avoid the temptation to make new technology match an existing process, or to limit the scope of change to the software being implemented. Entire processes might need to be redesigned for maximum usability and efficiency going forward. Look at the entire workflow, consider past experience and plan for continual improvements as business needs change.

  • Don’t skimp on training.

Plan for training before implementation begins, and budget for sufficient time and resources to get key users ready. Remember that not all users will have the same level of comfort with the new system, especially at the beginning. It’s also important to anticipate ongoing training needs due to employee turnover as well as future process change.

  • Keep the implementation phase as brief as possible.

Test software in conjunction with the process it supports to ensure a good fit. Start small and roll out changes in quick cycles. The planning process should include the development of SMART (specific, measurable, attainable, relevant and timely) goals and metrics that support ongoing system evaluation.

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