On Research - with CITI Program CITI Program

Access to research is a complicated but essential area of growing concern in the research industry. As technology advances, many smaller research sites and rural areas can’t compete or keep up. By narrowing the field of eligible research participants, we lose important patient populations. Jessica Rowe, the Director of Quality and Education at the Yale Cancer Center and the current President of the Society of Clinical Research Professionals (SOCRA), joins me in discussing this fascinating top...

Research security is about protecting the means, know-how, and products of U.S. research and development until they are ready to be shared. In 2021, the government issued a national presidential memorandum with updated requirements for institutions around research. Emily Bradford joins us to explain these new research security requirements and suggests how to grow or build a program to meet these updated requirements. Additional Resources: - The original National Security Presidential M...

A growing area of research involves exception from informed consent. In an emergency setting, participants can be enrolled in a trial without their consent. Mike Linke joins On Research to discuss the regulations and ethical considerations around this important area of research. Additional Resources: FDA Guidance Document for EFIC studies - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research...

A discussion about research site operations. We talk about the different types of sites, different recruitment strategies, how DCTs impact dedicated research sites, and the financial impact technology brings to sites. Adam Roth, the Vice President of Site Services at CTI, shares his experience and insights into the site world. Guest Bio: Adam Roth has been in the clinical research industry for over 25 years. He started out as a research coordinator, then manager. He moved into project m...

Our guest this month is Kate Cohen, the Chief Compliance Officer at SIU Medicine in Illinois. Kate breaks down the concept of research compliance, sharing best practices and practical guidance. We dive into essential elements of a compliance research program, as well as how someone new to this side of the industry can take steps to break in and learn more.  Additional Resources:  Updated OIG Guidance with 7 Elements https://oig.hhs.gov/compliance/compliance-guidance/ HCCA Conf...

This is a special edition of On Research with CITI Program. Guest hosted by Margaret Rankovic, Director of Content and Education at CITI Program, this podcast provides a recap, insights, and key takeaways from the recently concluded PRIM&R 2023 conference. The panel includes the following from CITI Program leadership team: Bharat Krishna, SVP & Managing Director; Jaime Arango, Vice President of Content and Education; Cid Gomes, Senior Director of Information Technology; and Gina Sulli...