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