Standard Operating Procedures
Our team has developed a uniform set of Standard Operating Procedures (SOPs) to promote quality performance and ethical conduct of clinical research. They define our group's routine processes in accordance to Good Clinical Practice (GCP), FDA regulations and UCSF guidelines.
Research staff are trained on departmental SOPs and deemed competent before any research procedures begin. To ensure our SOPs are in line or exceed industry standards, they are reviewed annually.
The current SOPs used by our department are listed below. If there is one that is not on the list that you would like to see implemented, please email Maya Aslam.
- 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
- Data Transfer
- Protocol Deviations
- Adverse Events and Serious Adverse Events Reporting
- Confidentiality of Information
- Drug/Device Storage, Accountability and Management
- Regulatory 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