Standard Operating Procedures

Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within a business organization. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances.

Our team is developing a uniform set of SOPs to promote quality performance and ethical conduct of clinical research. It will define our group's routine processes in accordance to Good Clinical Practice (GCP), FDA regulations and UCSF guidelines.

The anticipated SOPs that we would like to use for the department are listed below. If there is one that is not on the list that you would like to see implemented, please contact the Department's Clinical Research Coordinator, Veronica Andaya [email protected]; Ph: (415) 502-6314.

Common SOPs

GCP Training
Authority and Delegations of Responsibilities of Research Staff
Subject Screening and Recruitment
Informed Consent Process and Documentation
Eligibility Confirmation
Source Documentation
Data Management
Protocol Deviations
Adverse Events and Serious Adverse Events Reporting
Confidentiality of Information
Drug/Device Storage, Accountability and ManagementRegulatory Document Submission Process (Initial Submissions, Amendments and Continuing Reviews)
Sample Processing and Shipping Training
Monitoring Visits
Sponsor, CRO and Internal Audits
FDA Audits (Please see FDA Audit Section)
Writing SOPs
Record Organization and Retention
Sub-Site Management

Orthopaedic Research Administration

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Common SOPs