Does your research portfolio include human subject research and clinical trials? If so, please join us for one of our routinely hosted Coffee Break sessions to learn more about the ECS-HSR support services offered. These sessions are designed to review various topics on Good Research Practices and the Regulations that govern Human Subject Research. Each session is hosted virtually, and we offer dedicated time for open Q&A.
These sessions may be beneficial for the following individuals:
- Investigators new to research,
- Investigators new to the University,
- Research staff new to research, or
- Existing research staff.
Some informational topics which may be discussed at the sessions:
- Federal regulations and NIH policies surrounding GCPs in human subject research,
- Investigator Responsibilities,
- Tips for Protocol Adherence,
- Regulatory File Maintenance,
- ClinicalTrials.gov Registration and Maintenance
- Informed consent documents/consent process notes,
- Eligibility documentation,
- Screening/enrollment/randomization logs,
- Source documentation to substantiate adherence to the protocol, SOPs, applicable regulatory requirements, and Good Clinical Practice,
- Drug and device accountability records, if applicable, and
- Appropriate reporting of unanticipated problems/noncompliance/deviations and adverse events.
To register for the next virtual session visit the Pitt Events Calendar. Please email ECS-HSR@pitt.edu with any questions or ideas for session topics.