OPRS/IRB SOPs

Standard Revised Policy Date
OPRS SOP 101: Policies and Procedures Management
OPRS SOP 102: Training and Education
OPRS SOP 103: Management of OPRS Personnel
OPRS SOP 104: IRB Authority and Signatory Authority
OPRS SOP 201: Management and Composition of the IRB
OPRS SOP 202: Duties of IRB Members
OPRS SOP 203: OPRS Advisory Committee
OPRS SOP 301: Research Submission Requirements
OPRS SOP 302: Administrative Review and Distribution of Materials
OPRS SOP 303: IRB Review of Submissions
OPRS SOP 304: Convened IRB Meeting Administration
OPRS SOP 305: Documentation of IRB Discussions, Decisions and Findings
OPRS SOP 306: AD HOC Consultant Reviewers
OPRS SOP 307: Approval Period and Determination of Expiration
OPRS SOP 308: Document Management
OPRS SOP 401: Definition of Research Involving Human Subjects
OPRS SOP 402: Research Activities Exempt From IRB Review
OPRS SOP 403: Expedited Review
OPRS SOP 404: Initial Review – Criteria for IRB Approval
OPRS SOP 405: Continuing Review
OPRS SOP 406: Review of Amendments to Research Studies
OPRS SOP 407: Final Project Reports
OPRS SOP 408: IRB Actions to Approve or Disapprove Research
OPRS SOP 409: Medical Case Reports
OPRS SOP 410: Alternative IRB Review Arrangements and Agreements
OPRS SOP 411: Appeal of IRB Decisions
OPRS SOP 501: Vulnerable Populations in Research
OPRS SOP 502: Clinical Research Involving Investigational Drugs and Devices
OPRS SOP 601: Screening, Recruiting, and Advertising for Participant Enrollment
OPRS SOP 602: Payment for Participation in Research Studies
OPRS SOP 701: General Requirements Of Informed Consent
OPRS SOP 702: General Requirements Of Documentation Of Consent
OPRS SOP 703: Waiver Or Alteration Of Consent
OPRS SOP 704: Assent
OPRS SOP 802: Privacy And Confidentiality
OPRS SOP 901: Unanticipated Problems Involving Risks To Participants Or Others
OPRS SOP 902: Deviations
OPRS SOP 903: HRPP and Non-compliance
OPRS SOP 904: Administrative Hold, Suspension And Termination Of Research
OPRS SOP 905: Institutional Reporting Procedures
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