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SOP & Forms

Standard Operating Procedures and Forms


Introduction
(Click here to download)
Topics

  • Introduction
  • Vision and Mission of the Institution
  • Structure and Mandate
  • Abbreviation Index
  • Glossary

Forms

  • None

Chapter 1 (Click here to download)
Topics

  • Ethical Framework and Constitution of the IRB
  • Appointment of the IRB Members
  • Selection of Independent Consultants
  • Employment of Staff Secretariat

Forms

  • PELI IRB SOP Form 1.1 Confidentiality and Conflict of Interest Agreements 27 June 2017  (Download)
  • PELI IRB SOP Form 1.3 Training Record 27 June 2017 (Download)
  • PELI IRB SOP Form 1.4 Curriculum Vitae 27 June 2017 (Download)

Chapter 2 (Click here to download)
Topics

  • Management of Protocol Submissions
  • Use of Study Assessment Forms
  • Expedited Review
  • Full-Board Review of Submitted Protocols
  • Review of a Medical Device Study
  • Informed Consent Process
  • Assent from Children or Decision-Impaired Individuals
  • General Recruitment Practices and Advertisements

Forms

  • PELI IRB SOP Form 2.1 Application for Protocol Review 25 Oct 2017 (Download)
  • PELI IRB SOP Form 2.2 Protocol Evaluation Form 27 June 2017 (Download)
  • PELI IRB SOP Form 2.2.1 Protocol Evaluation Form For Technical Review 25 Oct 2017 (Download).
  • PELI IRB SOP Form 2.2.2 Protocol Evaluation Form For Ethical Review 25 Oct 2017 (Download).
  • PELI IRB SOP Form 2.3 Informed Consent Evaluation Form 27 June 2017 (Download)
  • PELI IRB SOP Form 2.4 Declaration of Conflict of Interest 27 June 2017 (Download)
  • PELI IRB SOP Form 2.9 Review of Resubmitted Study Protocol Form 27 June 2017 (Download)
  • PELI IRB SOP Form 2.10 Letter of Under Taking 19 Oct 2017 (Download).

Chapter 3 (Click here to download)
Topics

  • Review of Serious Adverse Events
  • Review of Amendments
  • Review of Progress/Final Report
  • Review of Protocol Violation/Deviation
  • Responding to Participant Requests/ Queries
  • Site Visits
  • Review of Early Protocol Termination
  • Suspension or Termination of IRB Approval
  • Continuing Review Application

Forms

  • PELI IRB SOP Form 3.1 Serious Adverse Event Form 25 Oct 2017 (Download)
  • PELI IRB SOP Form 3.2 Protocol Amendment Form 27 June 2017 (Download)
  • PELI IRB SOP Form 3.3 Progress Report Form 1 Feb 2016 (Download)
  • PELI IRB SOP Form 3.4 Final Report Form 1 February 2016 (Download)
  • PELI IRB SOP Form 3.5 Deviation Noncompliance Violation Report Form 25 Oct 2017 (Download)
  • PELI IRB SOP Form 3.6 Request Query Record 27 June 2017 (Download)
  • PELI IRB SOP Form 3.8 Early Study Termination Form 30 Aug 2013 (Download)
  • PELI SOP Form 3.12 Continuing Review Application 1 Feb 2016 (Download)

Chapter 4 (Click here to download)
Topics

  • Meeting Agenda
  • Minutes of the meeting
  • Preparation of Communication Records
  • Management of Active Study Files
  • Archiving of Terminated, Inactive, or Completed Studies
  • Maintenance of Confidentiality of Study Files and IRB Documents

Forms

  • PELI IRB SOP Form 4.3 Confidentiality Agreement Form for Non-Members 27 June 2017 (Download)

Chapter 5 (Click here to download)
Topics

  • Writing SOPs
  • Revising SOPs

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