This orientation provides a general overview of the National COVID Cohort Collaborative (N3C), including goals, organization, and community resources.

Topics include:

• Introducing the 3 data tiers available and important considerations for research driven by the data harmonization process
• Discussing resources for training and help, as well as the Data Use Request (DUR) process required for researcher access

Note: This orientation continues with Part B on February 9.

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TraCS Regulatory invites academic researchers, scientists, study coordinators, and students engaged in clinical research/clinical trials to the Clinical Protocol Development Workshop. This two-day workshop will provide attendees with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. There will be time for questions at the end of each presentation.

Day 2 Topics:

• Clinical Protocol Study Design - aims, objectives, endpoints, and outcomes
• Statistical Analysis, sample size considerations, data management
• Clinicaltrials.gov - outcome measure reporting
• Protocol problem spots and ways to improve protocols

ACRP Contact Hours: 4.0 Contact Hours of clinical research education on application for maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees

Presenter
Amanda Wood, CCRP, RAC, IND/IDE Program Coordinator
NC TraCS Institute

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