Ask Me Anything – Hitting the Target with Good Study Design
Mary Brenner, MSN MArch RN, is CRIO’s Study Design Manager and brings deep-rooted expertise as a registered nurse to CRIO’s in-house study design team. In this quick Q&A, Mary shares the benefits of good study design for sponsors and sites, the downstream effects of standardized study designs, and gives tips for designing it on your own.
What are the benefits of good study design for sponsors and sites?
Think of the study design as a blueprint for a clinical trial. As a registered nurse, I understand workflows, how assessments should be ordered, the requirements for lab procedures, and the kinds of healthcare verbiage presented in a protocol. With a thorough mastery of the terminologies that describe study designs, our in-house study design team can move even faster to deliver different study design builds. I’ve been with CRIO since 2017 and by now, I’ve been involved in over 500 studies, so my team and I are adept at working with protocols and building studies. Having this knowledge base is a huge benefit to our sponsor and site clients. Each study designer knows how studies should be conducted, how the workflows should be ordered, and best practices to help our clients achieve the best outcomes.
What are the downstream effects of standardized study designs for sites and sponsors?
CRIO Publisher (master templating), built directly into CRIO eSource, has a standardized template that is published to a master site. When it is ready to be published, subsequent versions are pushed out to all the other participating trial sites. All the sites are working from one template, or the same foundation. These sites can further customize the template by adding questions or forms to enhance their workflow, which gives sites the ability to tailor eSource templates as needed. Utilizing the CRIO model, with one template, allows sites and sponsors to stay compliant, keep everything in one place, and stay organized.
Tips for success for DIY study design?
Master CRIO’s functionality, and learn what the system can and can’t do. The next tip is to really read and understand the protocol. By doing so, you’ll understand the background of the drug, prior studies, why it is being created, and expectations for endpoints. You can’t train for all unique situations. You have to just dive in, dig in, and work on it. The more you do, the faster you can master the system’s functionality, and will then be capable of applying it to any special nuisance that a study may present. If you hit any roadblocks, find a workaround. On top of our highly responsive customer support, CRIO offer various other channels to get the answers you need, fast. I always encourage CRIO clients to check out the CRIO Forum, located inside our advanced Help Center. The forum allows CRIO users to directly interact and learn best practices from each other. I also recommend that clients explore our Study Design Marketplace, CRIO’s product hub for hundreds of customizable eSource study design templates, curated by our study design experts.
If you have a unique situation with a build, please reach out to studydesigns@clinicalresearch.
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