National Capital

SOCRA National Capital Area Chapter

Baltimore and National Capital Area Chapter Joint Meeting 2024

Friday 12/6/2024
10:00AM - 4:30PM EST
Location: The Belmont / Hockley Room, Elkridge Library
6540 Washington Blvd, Elkridge, MD 21075

RSVP Here: https://forms.gle/jFq6VpUjTjHyieSw6

You must RSVP at the link above to secure your spot. Spaces are limited. No fees are associated with meeting attendance. This is a full day in person event. For issues with registration or questions, contact SOCRABaltimore@gmail.com .

Drinks and food will be provided onsite for a cost of $15-$30 per person, depending on what you order. Once you RSVP, a link will be sent to you about a week before the event to order and pay for food online IN ADVANCE. Vegetarian and gluten free options will be available. The food you have ordered in advance will be delivered to the library the day of the event. You are always welcome to bring your own lunch.

Agenda:

10:00am:
Presenters: Sharon Flynn, Director, Patient Safety and Education, NHLBI and Deborah Grady, MS, BSN, CCRC, Quality Management Coordinator, NCI
Title: Quality Management in Clinical Research
Learning Objectives:
• Define components of quality management.
• Describe three examples of quality control activities that the team can perform involving the informed consent process.
• Determine two corrective and preventive actions if a research participant is found to be ineligible after enrolling.

11:10am:
Presenters: Saraf Salim and Michael Stidham, HHS Office for Human Research Protections
Title: Considerations for Providing Key Information for Participant-Centered Informed Consent
Learning Objectives:
• Understand the Common Rule requirements for Informed Consent and the regulatory requirement for Key Information sections for human subjects research.
• Provide an overview of OHRP and FDA’s joint draft guidance on Key Information and OHRP's Participant-Centered Informed Consent Training.
• Provide resources for formulating a Participant-Centered Key Information section for informed consent.

12:20pm – 1:50pm: Lunch and Networking
Food will be provided onsite for a cost of around $15-$30 per person. You have the option to order in advance or bring your own lunch. Details for ordering in advance provided above.

2:00pm:
Presenter: Casey Jackson, Director of Research Quality Improvement and Compliance, UMSON
Title: GCP Principles of Priority (in an Age of Rapid Change and Emerging Technology)
Learning Objectives:
• Discuss Changes in key GCP principles.
• Heighten awareness of emerging technology.
• Consider effect of emerging tech on key GCP principles.

3:10pm:
Presenter: Scott Wehage
Title: Medical Devices in Clinical Trials
Learning Objectives:
• Device Definitions.
• Device Classifications.
• Medical Device Regulations.

Credits Available: Up to 6 CE credits for SOCRA members

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