Managing an Ongoing Non-Therapeutic Research Project
Study documentation, research oversight, and reporting
Research teams are required to prepare and maintain regulatory documentation demonstrating appropriate study conduct, and comprehensive case histories on each research subject when applicable.
The Principal Investigator has the ultimate responsibility to oversee research conduct at their site and ensure required information is reported to the IRB and other regulatory bodies when applicable.
use of data and specimens
Research information and materials, including previously collected research data and specimens, are considered confidential. Their use and release controlled and governed by DF/HCC policies, IRB requirements, regulations, and contract terms.
Furthermore, any time data or specimens will be shared outside of a DF/HCC institution for research purposes, specific steps must be taken to ensure the subject and the institution is protected.
Changes to Approved Research
There are many types of changes that can occur during an ongoing research project. Many of these changes require approval by the IRB of record.
Please review the sections below for more information on different types of changes and what is required.
Additional Resources for sponsor-investigators
Guidance for adding external sites to an investigator-sponsored study.
Closing a study and sharing data
There are specific requirements when preparing to share and/or publish data or complete a research project. In addition to DF/HCC requirements, there may be study-specific stipulations (e.g., in the protocol or contract) that must be followed.