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

SOP 04 - Protocol Feasibility

SOP 05 - Site Qualification Visit

SOP 06 - Essential Document Management and Retention

SOP 07 - Informed Consent Form Development

SOP 08 - Site Initiation Visits

SOP 09 - Protocol Implementation

SOP 10 - Subject Screening and Recruitment

SOP 11 - Obtaining Informed Consent

SOP 12 - Protocol Compliance

SOP 13 - Adverse Event Reporting

SOP 14 - Research Specimen Management

SOP 15 - Investigational Product Management

SOP 16 - Data Management

SOP 17 - Monitoring Visits

SOP 18 - Clinical Research Audits

SOP 19 - Payments to Human Subjects

SOP 20 - Single and Multi-Site Investigator Initiated Trials