SOPs

These documents are for outlining how a process is to be completed. Most of the SOPs in this section are for OIA; however, SOPs for research teams are listed in this section as well.

Investigators

013 Legally Authorized Representatives, Children, and Guardians

090 Informed Consent Process for Research

091 Written Documentation of Consent

092 Assent Process for Research

093 Written Documentation of Assent

094 Human Research Internet Recruitment

095 Clinical Research Volunteer Registry Recruitment

103 IRB Handbook

Administrative Review

020 Incoming Items Directed to the Office of IRB Administration

021 Pre-Review

023 Emergency Use Review

024 Reportable Events

026 Suspension or Termination of IRB Approval

Non-Committee Review

031 Non-Committee Review Preparation

032 Non-Committee Review Conduct

063 Expiration of IRB Approval

Committee Review

040 IRB Meeting Preparation

041 IRB Meeting Conduct

042 IRB Meeting Attendance Monitoring

043 IRB Meeting Minutes

Review Addenda

051 Consultation to the IRB

052 Post-Review

055 Financial Conflicts of Interest

Reliances and sIRBs

058 UCSD Relying on an External IRB

059 UCSD Serving as the IRB of Record

085 Establishing Reliance Agreements

OIA Operations

001 Definitions

012 Observation of the Consent Process

071 Standard Operating Procedures

Previous SOPPs and SOPs

Previous SOPPs/SOPs which are no longer in effect but may still be needed by researchers to aid in audits by Sponsors or Regulatory Agencies can be found on our Previous SOPPs/SOPs webpage.