Clinical Protocol Development Series

The goal of this two-day series is to provide researchers with the knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9:00 AM and a question-and-answer session will follow each presentation.

The first day of the series will provide an introduction and focus on the following key points:
- Who needs a clinical protocol and why it is important
- UNC Scientific Review Committee processes
- Types of clinical protocols, and content expectations for sections of the protocol
- Resources and tools available at UNC to support clinical protocol development

Audience: academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.

ACRP Contact Hours: 2.0 Contact Hours of clinical research education on the application for maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees

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Modular design and automated testing in R

This 2-part, 6-hour course will be split over 2 days and offered via Zoom. Attendance is required as the course will not be recorded.

Research is relying on increasingly complex code. However, most academics have not received formal training in software development. This course will introduce participants to some of the best practices of professional software development. Participants will learn to structure their R code into reusable functions and store those functions as separate scripts and/or packages. Participants will learn to write automated tests for their functions, to help confirm that results are as expected and to ensure that future changes to code do not cause unexpected changes to results.

In this course, participants will also learn how to create reproducible “environments” that record package versions in use to help avoid package version incompatibilities and ensure that results can be replicated even months or years after the original analysis.

Many R users code using the R markdown or Quarto systems that allow integrating text with code. In this course, participants will learn how these useful tools can affect modular design, and how to use them together. No previous R Markdown or Quarto experience is required. Modular design is best paired with a version control system and integrates with Git and Github.

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Why Do We Have IRBs?

Please join Charlote Coley, MACT, CIP, from the UNC Office of Human Research Ethics, and the UNC Network of Research Professionals for a discussion about Institutional Review Boards (IRBs) and why we have them.

Research that includes human subjects must be reviewed and approved by an Institutional Review Board prior to enrolling subjects. Why is this both a Federal regulatory and ethical requirement? What prompted this legislation and process?

Objectives:
- Historic background that prompted the need for these national and international statements/declarations about research involving human subjects
- What more recent events have prompted re-examination and interpretation of these regulations and guidelines
- How these events have shaped the purpose and function of the IRB

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