Introduction to REDCap 21 CFR Part 11 Validated System
IND and IDE Support (IIS) and Health Science Information Technology (HSIT)
April Lehman, MPPM, Program Manager, IIS
Tyler Nicoletti, MBA, PMP, CSM, Technical Project Manager, HSIT
March 4, 2024
Presented by the Division of Education and Compliance Support for Human Subject Research (ECS-HSR) in conjunction with the Health Sciences Information Technology (HSIT). This presentation covers the use of the 21 CFR 11 validated instance of REDCap including the rationale for implementation, a brief overview of the process, and plans for moving forward. The use of the validated instance of REDCap is limited to those conducting research under a faculty-held Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) and is required for new research studies submitted to the FDA after January 1, 2024.
View the program questions and answers
Good Research Practices
Education and Compliance Support (ECS)
Kelly Dornin-Koss, Director, ECS-HSR
Melissa Miklos, Associate Director, HRP
Maggie Soncini, Coordinator, ECS-HSR
University of Pittsburgh, Education and Compliance Support for Human Subject Research
December 14, 2020
Overseeing a research study can be challenging, especially if you are new to the research environment. This webinar 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.
Regulatory File Maintenance
University of Pittsburgh, Education and Compliance Support for Human Subject Research
This training covers the basic principles of maintaining a regulatory documents file for studies that involve human subjects.
Regulatory File Maintenance Training
ClinicalTrials.gov
Clinical Trial Registration & Transparency Support (CTRTS)
Patrick Fawcett, BS, Information Disclosure Administrator, CTRTS
University of Pittsburgh, Education and Compliance Support for Human Subject Research
This training is relevant for anyone working on investigator initiated clinical studies. The training covers the background context of ClinicalTrials.gov, current requirements for submission of clinical study information, and a high-level overview of the submission process.
ClinicalTrials.gov Training
ClinicalTrials.gov: Avoiding Common Errors
Clinical Trial Registration & Transparency Support (CTRTS)
Patrick Fawcett, BS, Information Disclosure Administrator, CTRTS
University of Pittsburgh, Education and Compliance Support for Human Subject Research
This session will cover common errors in submissions to ClinicalTrials.gov, and how to avoid them.
ClinicalTrials.gov: Avoiding Common Errors