Multicenter Research: Investigator-Sponsored IND/IDE
IND and IDE Support (IIS)
April Lehman, MPPM, Regulatory Specialist, IIS
Courtney Wilkes, MA, Coordinator, IIS
University of Pittsburgh, Education and Compliance Support for Human Subject Research
November 20, 2020
Conducting multi-center research under a Sponsor-Investigator held IND or IDE is highly complex and there are several considerations a Sponsor should be aware of before deciding to take responsibility for activities at external sites. This talk provides practical information on Sponsor responsibilities which include, but are not limited to: selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the protocols contained in the IND/IDE, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the investigational product.
Emergency Access to Investigational Products
IND and IDE Support (IIS)
April Lehman, MPPM, Regulatory Specialist, IIS
Courtney Wilkes, MA, Coordinator, IIS
University of Pittsburgh, Education and Compliance Support for Human Subject Research
November 20, 2020
Healthcare professionals are rarely prepared for the need to make a request to FDA for an emergency IND or IDE to gain access to a potentially life-saving or changing investigational drug or medical device. This presentation offers a step-by-step approach on the process for making a request to the FDA. Additional information is provided with respect to providing the necessary follow-up information to the FDA.
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