Responsible Research Practices

Standard Operating Procedures for Good Clinical Research Practice

All clinical research investigators and staff are subject to review of their clinical research practices by local, regional and/or federal regulatory authorities as well as sponsors, as appropriate. The documents below contain standards operating procedures (SOPs) for clinical research investigators and research teams. While these SOPs reflect sponsored and FDA regulated research, they can guide or inform processes associated with other types of clinical research (e.g., investigator-initiated). Please read Introduction for additional information.

Introduction to Standard Operating Procedures (SOPs)

Table of Contents, Glossary + References

SOP 01 - Training, Writing and Maintenance of SOPs

SOP 02 - Delegation of Responsibilities

SOP 03 - New Employee Orientation