In today’s post, the sixth in the series on the TransCelerate Shared Investigator Platform (SIP), we offer guidance and best practices for early adopters of the SIP. For more background information on TransCelreate or the SIP, or for guidance directed toward companies that have not joined TransCelerate or adopted the SIP, see the previous posts.
For those of you who are members of TransCelerate and are committed to tackling the challenges that come with the SIP to make life easier on your investigators, here are some ideas to consider:
Establish a formal SIP Program with a formal governance board. The board should include representatives from all internal stakeholder groups, and potentially a neutral third party (a trusted advisor) to help facilitate discussion and decision making.
Implement a standardized, objective decision-making process for the board to follow.
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Ask your site users what they think and how they feel about working on your studies. Ask them about their tolerance for change, how much advance notice they need, the type of training they prefer, etc. And keep asking over time.
Implement a standardized release schedule for all site-facing applications and processes, including the SIP, that balances your business needs with your users’ tolerance for change. The board should collectively decide which changes to include in each standardized release.
Establish working committees to tackle specific challenges related to the SIP. Pull in technical experts, as needed, to help tease these out and identify the best path forward. Once the path forward is agreed upon, weave the related changes into the standardized release schedule.
Implement a standardized change management approach that includes communication with and training for site users, based on their feedback.
In our next and final post in this series, we’ll provide links back to all of the posts in this series, as a reference, as well as offer additional resources for you. In the meantime, check out this brief video that describes a project we completed for one of the TransCelerate member companies, and fill out the form below to download our related guide, Perspectives on the TransCelerate Shared Investigator Platform.