Study Start Up

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2023 Agenda

Saturday, September 30th at  1:40 to 2:25                                                                                                                       Track: Study Start-up

Compliance in Regulatory Start Up: Tips and Tricks to Expedite Study Start Up (from a site perspective)

Everyone wants study start up to be both accurate and speedy. Ms. Gruetzmacher will go over essential areas of study start up from a site perspective, and how to quickly and accurately get trials ready for enrollment. Some of the items to be discussed include what needs to go on a 1572, which documents to ask staff for, tips and tricks gleaned from HHS emails/FAQs, delegation logs, what trainings are needed and how to document training, what is needed for an IRB submission, what should be submitted, scheduling site initiation visits, investigator meetings, and so much more. 525
Presenter: Crystal Gruetzmacher, CCRC, CHRC, Clinical Research Coordinator, Monument Health Clinical Research 

Saturday, September 30th at 2:30 to 3:15                                                                                                                                     Track: Study Start-Up 

Tips and Tricks: Improving Study Success Through Comprehensive Internal Feasibility Considerations

Feasibility considerations are fundamental for both sponsors and sites conducting clinical research. Yet, sometimes study protocol specific areas are not explored sufficiently on the front end leading to delayed study start-up, poor enrollment, and protocol noncompliance. This session will cover how to conduct thorough and consistent internal feasibility reviews including special considerations such as cybersecurity. 527
Presenter: Cynthia Dunn, MSN, CCRP, RN, CCRA, Clinical Research Consultant, Crescent City Research Consulting LLC
Presenter: Wendy Portier, MSN, RN, CHRC, CHC, Consultant, Portier & Associates, LLC