Good Research Practices (12/7/21)

Slides 12/7/21

Full Recording 12/7/21

Recording Index:

  • GCP and the NIH Adoption of GCPs - Kelly Dornin-Koss (start)
  • PI Responsibilities - Deb Montrose (8:27)
  • Protocol Development, Waivers of Informed Consent, and PittPRO - Melissa Miklos (30:40)
  • Informed Consent - Maggie Soncini (1:15)
  • Study Documentation - Kelly Dornin-Koss (1:59)

Description:

Overseeing a research study can be challenging, especially if you are new to the research environment. This workshop will provide an overview of the various components of Good Research Practices. This program is strongly encouraged for new investigators and coordinators as they start their clinical research careers as well as those with research experience.

Topics to be discussed include: Federal Regulations Governing Human Subject Research,  Protocol Development, Tips for Protocol Adherence, Investigator Responsibilities, Informed Consent and Waivers of Consent, Study Documentation, and Regulatory File Maintenance.

Note: This program was performed for UPMC Western Psychiatric Hospital and occasionally contains items specific to psychiatric research.  However, most of the session is applicable to all types of research

Instructor(s)

  • Kelly Dornin-Koss, MPPM, RN, CCRC, CIP; Debra Montrose, PhD; Maggie Soncini, BSN, ADN