Managing an Ongoing Clinical Research Project
Maintaining Study Documentation
Research teams are required to prepare and maintain regulatory documentation demonstrating appropriate study conduct, and comprehensive case histories on each research subject
Please review the sections below for more information. Additional documentation requirements related to events or information that requires reporting to the DF/HCC, IRB, regulatory agencies, or other oversight bodies can be found in the Oversight and Reporting tab on this page.
Research Oversight and Required Regulatory Reporting
The Principal Investigator has the ultimate responsibility to oversee research conduct at their site and ensure required information is reported to the IRB, FDA, and other regulatory bodies when applicable.
DF/HCC research is also subject to internal oversight via monitoring, internal audits, and ongoing review by applicable oversight committees such as the SRC, DSMC and DSMB.
Additional resources for sponsor investigators
DF/HCC investigators who sponsor their own research projects have additional responsibilities to ensure appropriate oversight and compliance with reporting requirements.
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.
There are additional requirements for sharing and publishing data as well as responsibilities for completing research at all participating sites for a DF/HCC investigator-sponsored study.