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SOP & Forms

Introduction 1
SOP 01 – Ethical Framework and Constitution of the IRB.pdf
SOP 02 – Appointment of the IRB Members.pdf
SOP 03 – Selection of Independent Consultants.pdf
SOP 04 – Employment of the Staff Secretary.pdf
SOP 05 – Training of IRB Members and Staff.pdf
SOP 6A – Management of Protocol Submissions.pdf
SOP 6B – Management of Protocol Resubmissions.pdf
SOP 07 – Exemption from Review.pdf
SOP 08 – Use of the Study Assessment Forms.pdf
SOP 09 – Expedited Review.pdf
SOP 10 – Full Board Review.pdf
SOP 11– Review of a Medical Device Study.pdf
SOP 12 – General Recruitment Practices and Advertisements.pdf
SOP 13 – Review of SAEs and SUSARs.pdf
SOP 14 – Review of Amendments.pdf
SOP 15 – Review of Progress/Final Report.pdf
SOP 16 – Review of Protocol Violation/Deviation.pdf
SOP 17 – Responding to Participant Queries and Complaints.pdf
SOP 18 – Management of Appeals.pdf
SOP 19 – Site Visits .pdf
SOP 20 – Early Protocol Termination.pdf
SOP 21 – Suspension or Termination of IRB Approval.pdf
SOP 22 – Application for Continuing Review.pdf
SOP 23 – Preparing for a Meeting.pdf
SOP 24 – Preparation and Distribution of Meeting Agenda.pdf
SOP 25 – Conduct of Meeting.pdf
SOP 26 – Preparation of Minutes of Meeting.pdf
SOP 27 – Preparation of Communication Records.pdf
SOP 28 – Communicating IRB Decisions.pdf
SOP 29 – Management of Active Study Files.pdf
SOP 30 – Archiving of Terminated, Inactive or Completed Studies .pdf
SOP 31 – Maintenance of Confidentiality of Study Files and IRB Documents.pdf
SOP 32 – Writing SOPs.pdf
SOP 33 – Revising SOPs.pdf
Glossary.pdf
PELI-IRB List of Forms
PELI IRB Form 2.1 Application for Protocol Review 28 June 2023.PDF
PELI IRB Form 2.2.1 Protocol Evaluation Form For Technical Review 17 Oct 2017.PDF
PELI IRB Form 2.2.2 Protocol Evaluation Form For Ethical Review 17 Oct 2017.pdf
PELI IRB Form 2.2.3 Study Protocol Assessment form for Exemption from Ethical Review.pdf
PELI IRB Form 2.3 Informed Consent Evaluation Form 28 June 2023.pdf
PELI IRB Form 2.4 Declaration of Conflict of Interest 27 June 2017.pdf
PELI IRB Form 2.5 Notification of IRB Decision 26 January 2016 .pdf
PELI IRB Form 2.6 Approval Letter 26 Janaury 2016.pdf
PELI IRB Form 2.7 Request Information for Post Approval Procedures 26 January 2016.pdf
PELI IRB Form 2.8 Approval Letter for Post Approval Procedure 26 Jan 2016.pdf
PELI IRB Form 2.9 Review of Resubmitted Study Protocol Form 27 June 2017.pdf
PELI IRB Form 2.10 Letter of Under Taking 17 Oct 2017.pdf
PELI IRB Form 2.11 Document Decision Form - Exempted From Ethical Review.pdf
PELI IRB Form 3.1 Serious Adverse Event Form 27 Jun 2017.pdf
PELI IRB Form 3.2 Protocol Amendment Form 28 June 2023.pdf
PELI IRB Form 3.3 Progress Report Form 28 Jan 2023.pdf
PELI IRB Form 3.4 Final Report Form 26 June 2023.pdf
PELI IRB Form 3.5 Deviation Noncompliance Violation Report Form 27 June 2023.pdf
PELI IRB Form 3.6 QUERY COMPLAINT RECORD 27 June 2023.pdf
PELI IRB Form 3.7 Site Visit Form 26 JAN2016.pdf
PELI IRB Form 3.8 Early Study Termination Form 26 Jan 2023.pdf
PELI IRB Form 3.10 Decision Letter-Management of Appeals.pdf
PELI IRB Form 3.11 Reminder Letter for Continuing Review or Final Report 26Jan2016.pdf
PELI IRB Form 4.1 Agenda of the Meeting 27 June 2017.pdf
PELI IRB Form 4.2 Minutes of Meeting Oct 2022.pdf
PELI IRB Form 4.3 Confidentiality Agreement Form for Non-Members 27 June 2017.pdf
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