Five Tips for Minimizing Mid-study Change Delays

According to a survey published in Applied Clinical Trials, study changes and their associated delays topped the list of challenges faced while conducting a clinical trial.

Mid-study changes and the need to update RTSM design are often inevitable, especially in adaptive trials. However, there are ways to minimize the impact and even embrace this need for change.


1) Begin with a clear statement of the required change. It’s important to confirm with all stakeholders that the wording of the change is clear and correct. Misinterpretations can cost more in time and money than the change itself.

2) Remember that there is often more than one way to implement a change. Implementation approaches often affect the time and effort (and cost!) of any given change; a clear understanding of the overall goal is a must.

Cultivate partners whose project management and technical teams offer creative solutions to study problems. Team members that foster good dialogue between all members of the study team can facilitate effective solutions.

3) Confirm that the lines of authorization in the study are clearly established and adhered to by all team members. Obtain written confirmation from the person(s) designated at the study startup as authorized to order a change.

4) Check to make sure that a suite of quality controls is in place for proper implementation of the change and to capture and address any unexpected consequences that might result.

5) Ensure that technical audit trails and your document repository together constitute a clear information trail pre- and post-change.


The Veeva RTSM system is designed to expedite clinical trials and any mid-study changes – it’s modular and quick to configure, so we can meet tight deployment timelines. It offers complete functionality; so you will never risk beginning a trial, encountering a mid-study change and finding out that your solution no longer supports your needs.


To learn more about how Veeva RTSM can support your next clinical trial, contact us to schedule a conversation or demo.