SOPs

HRP-012 – SOP Observation of the Consent Process

HRP-013 – SOP Legally Authorized Representatives, Children, and Guardians

HRP-020 – SOP Incoming Items

HRP-021 – SOP Pre-Review

HRP-023 – SOP Emergency Use

HRP-024 – SOP Reportable New Information

HRP-026 – SOP Suspension or Termination Issued Outside of Convened IRB

HRP-027 – SOP Compassionate Use (Device Only), and IRB Waiver for Individual Patient Expanded Access (Drug Only)

HRP-029 – SOP Suspension or Termination of IRB Approval by Convened Panel

HRP-030 – SOP Designated Reviewers

HRP-031 – SOP Non-Committee Review Preparation

HRP-032 – SOP Non-Committee Review Conduct

HRP-033 – SOP Determining and Processing When Continuing Review is Required

HRP-040 – SOP IRB Meeting Preparation

HRP-041 – SOP IRB Meeting Conduct

HRP-042 – SOP IRB Meeting Attendance Monitoring

HRP-043 – SOP IRB Meeting Minutes

HRP-044 – SOP Not Otherwise Approvable Research, Not Federally Funded

HRP-045 – SOP Not Otherwise Approvable Research, Federally Funded

HRP-050 – SOP Conflicting Interests of IRB Members

HRP-051 – SOP Consultation

HRP-052 – SOP Post-Review

HRP-056 – SOP IRB Review of Conflict of Interest

HRP-060 – SOP Annual HRPP Evaluations

HRP-061 – SOP Ongoing HRPP Evaluations

HRP-063 – SOP Lapse (Expiration) of IRB Approval (Continuation of Current Participants)

HRP-064 – SOP NIH GDS Institutional Certification

HRP-070 – SOP IRB Records

HRP-071 – SOP Standard Operating Procedures

HRP-072 – SOP Document Management and Record Retention of Institutional Review Board Records

HRP-080 – SOP IRB Formation

HRP-081 – SOP IRB Removal

HRP-082 – SOP IRB Membership Addition (Appointment and Re-Appointment)

HRP-083 – SOP IRB Membership Removal

HRP-084 – SOP IRB Meeting Scheduling and Notification

HRP-090 – SOP Informed Consent Process for Research

HRP-091 – SOP Written Documentation of Consent and Assent

HRP-092 – SOP External IRBs

HRP-093 – SOP IRB of Record for Multi-Site Research

HRP-094 – SOP External Reporting Process

HRP-095 – SOP Handling Complaints & Allegations of Non-Compliance

HRP-096 – SOP Principal Investigator (PI) Permission

HRP-801 – SOP Establishing Authorization Agreements

HRP-802 – SOP Institutional Profile Management

Post-Approval Monitoring SOPs

HRP-025 – SOP Directed Review (For Cause) Audits

HRP-028 – SOP Post-Approval Monitoring

HRP-097 – SOP Post Approval Monitoring – Recruitment Materials and Process

HRP-098 – SOP Corrective and Preventive Action (CAPA) Plan Assessments