Read here: SOP I- Structure and Composition

SECTIONS

     1: Objectives

     2: Scope

     3: Responsibilities

     4: Regular Constitution and Functions

5. Workflow: Appointment of the UPD REB Chair 

6. Workflow: Appointment of Panel Members 

7. Workflow: Appointment of UPD REB Personnel

8. Workflow: Selection and Appointment of Independent Reviewers

9. Workflow: Confidentiality and Conflict of Interest Agreement

10. Workflow: Training of UPD REB Members

11. Workflow: Compensation for UPD REB Reviewers       

SOP FORMS

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     1(A): UPD REB Personnel Nomination and Appointment

     1(B): UPD REB Panel Member Nomination

     1(C): UPD REB Independent Reviewer Nomination

     1(D): Curriculum Vitae

     1(E): Confidentiality and Conflict of Interest Agreement

     1(F): Training Record

     1(G): Training Request Form

Read here: SOP II- Study Protocol Review

SECTIONS

     1: Objectives

     2: Scope

     3: Responsibilities

     4: Initial Protocol Review Workflow

     5: Panel Meeting Workflow

     6: Special Meeting Workflow

     7: Management of Resubmissions

     8: Management of Appeals for Reconsideration

SOP FORMS

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     2(A): Review Checklist

     2(B): Registration and Application Form

     2(C): Study Protocol Assessment Form

     2(D): Informed Consent Assessment Form

     2(E): Meeting Agenda

     2(F): Review of Resubmitted Protocol Form

     2(G): Confidentiality Agreement for Guests Observers

     2(H): Notice of Review

     2(I): Acknowledgement Letter

     2(J): Checklist for Exemption from Ethical Review

     2(K): Changes or Revisions in Protocols Classified as Exempted

     2(L): Appeals for Reconsideration

Read here: SOP III- Post-Approval Review

SECTIONS

     1: Objectives

     2: Scope

     3: Responsibilities

     4: Workflow of Post-Approval Review

          4.1: Continuing Review Application

          4.2: Study Protocol Amendment

          4.3: Noncompliance (Deviation or Violation) Report 

          4.4: Early Study Termination Report 

          4.5: Final Report

5: Management of Reportable Negative Events (RNEs)

     6: Management of Queries and Notifications

     7. Management of Complaints

SOP FORMS

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     3(A): Continuing Review Application

     3(B): Study Protocol Amendment

     3(C): Noncompliance (Deviation or Violation) Report

     3(D): Early Study Termination Report

     3(E): Final Report

     3(F): Reportable Negative Events (RNEs) Report

     3(G): Queries and Notifications

     3(H): Complaints

Read here: SOP IV- Documentation & Archiving

SECTIONS

     1: Objectives

     2: Scope

     3: Responsibilities

     4: Minutes of the Meeting Workflow

     5: Study Protocol Communication Records Workflow

     6: Administrative Records Workflow

     7: Active Files Workflow

     8: Archived (Inactive/Completed/Terminated) Files Workflow

     9: Confidentiality of Study Files and Documents Workflow

SOP FORMS

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     4(A): Format of the Minutes of the Meeting

     4(B): Certification of Approval

     4(C): Notice of Panel Action to Study Protocol Submissions

     4(D): Letter for Clarificatory Interview

     4(E): Notice of Panel Action to Continuing Review Application/Study Protocol Amendment/ Noncompliance Report/ Early Study Termination Report/ Final Report/ Reportable Negative Events/ Communication of Queries and Notifications/ Communication of Complaints

     4(F): Archiving Notification

     4(G): Confidentiality Agreement for Non-Members

     4(H): Log of Request for Access of Documents

     4(I):  Submissions and Issuances Log

     4(J):  Reminder Letter for Continuing Review or Final Report

     4(K): Notice of Protocol Submission Status

     4(L): Index of Protocol Folder Contents

     4(M): Certification of Exemption from Ethical Review

     4(N): Study Protocol Database

     4(O): Administrative Meeting Agenda Template

     4(P): Administrative Meeting Minutes Template

     4(Q): Letter of Exemption from Ethical Review for Case Reports

     4(R): Panel Action for Exemption 

     4(S): Communications

Read here: SOP V- Preparing SOPs & Guidelines 

SECTIONS

     1: Objectives

     2: Scope

     3: Responsibilities

     4: Workflow in the Preparation of the  Standard Operating Procedures (SOPs) and Guidelines

     5: Writing and Review of New SOP or Guideline

     6: Presentation of New/Revised SOP/Guideline to the UPD REB

     7: Decision of UPD REB Action on New/Revised SOP/Guideline

     8: Approval of New/Revised SOP/Guideline for Implementation

     9: Dissemination and Storage of New/Revised SOP/Guideline

SOP FORMS

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     5(A): SOP or Guideline Template

     5(B): SOP or Guideline Cover Page

     5(C): Request for Revision of SOP or Guideline

     5(D): Document History