SOPs and Forms

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Introduction

  1. Standard Operating Procedures (Introduction)

SOP I

  1. Standard Operating Procedures I (Structure and Composition)
  2. UPMREB FORM 1(A)2014 UPMREB Panel-Based Personnel Nomination and Appointment
  3. UPMREB FORM 1(C)2012 Confidentiality Agreement and Conflict of Interest Disclosure
  4. UPMREB FORM 1(B)2012 Curriculum Vitae
  5. UPMREB FORM 1(D)2012 Training Record
  6. UPMREB FORM 1(E)2012 Training Request Form
  7. UPMREB FORM 1(F)2012 Service Agreement for Independent Consultants
  8. UPMREB FORM 1(G)2014 UPMREB Non-Panel-Based Personnel Nomination and Appointment

SOP II

  1. Standard Operating Procedures II (Protocol Review)
  2. UPMREB FORM 2(A)2012 Review Checklist
  3. UPMREB FORM 2(B)2012 Registration and Application Form
  4. UPMREB FORM 2(C)2012 Study Protocol Assessment Form
  5. UPMREB FORM 2(D)2012 Informed Consent Assessment Form
  6. UPMREB FORM 2(E)2012 Site Resources Checklist for Clinical Trials Outside UP PGH by UPM Personnel
  7. UPMREB FORM 2(F)2012 Site Resources Checklist for Clinical Trials Outside UPM PGH By Non-UPM Personnel
  8. UPMREB FORM 2(G)2012 Meeting Agenda
  9. UPMREB FORM 2(H)2012 Review of Resubmitted Protocol Form
  10. UPMREB FORM 2(I)2012 Confidentiality Agreement for Guests Observers
  11. UPMREB FORM 2(J)2014 Notice of Review
  12. UPMREB FORM 2(K)2012 Acknowledgement Letter
  13. Checklist for Exemption from Ethical Review

SOP III

  1. Standard Operating Procedures III (Post-Approval Review)
  2. UPMREB FORM 3(A)2012 Study Protocol Amendment Submission Form
  3. UPMREB FORM 3(B)2012 Continuing Review Application Form
  4. UPMREB FORM 3(C)2012 Final Report Form
  5. UPMREB FORM 3(D)2012 Study Non-Compliance Report
  6. UPMREB FORM 3(E)2012 Early Study Termination Report Form
  7. UPMREB FORM 3(F)2012 Site Visit Report Form
  8. UPMREB FORM 3(G)2012 Suspected Unexpected Serious Adverse Events Report
  9. UPMREB FORM 3(H)2012 Notice of Site Visit
  10. UPMREB FORM 3(I)2012 Queries, Notification and Complaints
  11. UPMREB FORM 3(J)2012 SAE SUSAR Summary Report
  12. UPMREB FORM 3(K)2018 SAE and SUSAR Protocol-specific Summary of Reviews

SOP IV

  1. Standard Operating Procedures IV (Documentation and Archiving)
  2. UPMREB FORM 4(A)2012 Format of the Minutes of the Meeting
  3. UPMREB FORM 4(B)2019 Certification of Approval
  4. UPMREB FORM 4(C)2019 Notice of Panel Action to Study Protocol Submissions
  5. UPMREB FORM 4(D)2012 Letter for Clarificatory Interview
  6. UPMREB FORM 4(F)2012 Notification Letter (Request Information) To Continuing Review Application, Final Report, Deviation, SAE, Site VIsit
  7. UPMREB FORM 4(G)2012 Archiving Notification
  8. UPMREB FORM 4(H)2012 Borrowers Log
  9. UPMREB FORM 4(I)2012 Confidentiality Agreement for Non-Members
  10. UPMREB FORM 4(J)2012 Log of Request for Copies of Documents
  11. UPMREB FORM 4(M)2012 Submissions Log
  12. UPMREB FORM 4(N)2012 Reminder Letter for Continuing Review or Final Report
  13. UPMREB FORM 4(P) 2013 Index of Protocol Folder Contents
  14. UPMREB FORM 4(Q)2019 Request for UPMREB Certification of Exemption from Ethical Review

SOP V

  1. Standard Operating Procedures V (Preparing Standard Operating Procedures (SOPs) and Guidelines)
  2. UPMREB FORM 5(A)2012 SOP or Guideline Template
  3. UPMREB FORM 5(B)2012 SOP or Guideline Cover Page
  4. UPMREB FORM 5(C)2012 Request for Revision of SOP or Guideline
  5. UPMREB FORM 5(D)2012 Document History

SOPs

  1. General Policies and Guidelines
  2. Guideline on Reporting Serious Adverse Events
  3. Glossary
  4. Appendices
  1. Memorandum No. CCDP 2019-152
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