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About IERB 
LCP-IERB Guidelines
SOP
List of Forms
Organizational Chart

 

The Lung Center of the Philippines – Institutional Ethics Review Board is dedicated in providing quality health care through research.

An independent body crated by the LCP under the Office of the Executive Director, whose scope of work and responsibility is to ensure the protection of rights, safety and well being of human subjects involved in health related research and to provide public assurance of that protection. In accordance with applicable national/international regulations, the LCP-IERB has the authority to approve, require modifications to, or disapprove researches.

The Lung Center of the Philippines- Institutional Ethics Review Board reviews and monitors health researchers that involve LCP patients done within the LCP, or using LCP facilities.

a) initiated by LCP staff (consultants/residents/fellows; nurses and
    other hospital staff

b) pharmaceutically sponsored researches, wherein the Primary
    Investigators are LCP staff

LCP-IERB post fire was re-established in 2003. Historically, approximately 20-25 research protocols are reviewed annually more than half are protocols submitted by trainees (fellows and residents), the rest are pharmaceutically sponsored clinical trials with funding.

The LCP-IERB Standard Operating Procedures (SOP) has adapted the Department of Health SOP. It has incorporated provisions of the existing guidelines of the LCP-IERB and the ICH-GCP. This is a revision made from the February 27, 2009 SOP.

LCP-IERB Guidelines

 

List of Forms

I.  SOP 1 - Standard Operating Procedures (Structure and Composition) 
1. LCPIERB Letter 1 (A) - 2018 Invitation Letter to Regular Member
  2. LCPIERB Letter 1 (A2) - 2018 :   Invitation Letter to Alternate Member
3. LCPIERB Letter 1 (A3) - 2018 Invitation Letter to Independent Consultant
4. LCPIERB Letter 1 (B) - 2018 :  Appointment Letter of Chairman
5. LCPIERB Letter 1 (C) - 2018 :  Appointment Letter of Vice - Chairman
6. LCPIERB Letter 1 (D) - 2018 :  Appointment Letter of Secretary
7. LCPIERB Letter 1 (E) - 2018 :  Appointment Letter of Regular Member
8. LCPIERB Letter 1 (E2) - 2018 :  Appointment Letter of Alternate Member
9. LCPIERB Letter 1 (E3) - 2018 :  Appointment Letter of Independent Consultant
10. LCPIERB Letter 1 (F) - 2018 :  Confidentiality Agreement and Conflict of Interest Disclosure Form
11. LCPIERB Form 1 (G) - 2013 :  Curriculum Vitae
  12. LCPIERB Letter 1 (H) - 2014  Training Record of an IERB Member
  13.  LCPIERB Form 1 (I) - 2014  :  Training Request
II.  SOP 2 - Standard Operating Procedures (Initial Review Procedures) 
1. LCPIERB Form 2 (A) - 2018 :  Document Receipt Form
2. LCPIERB Form 2 (B) - 2018 :  Application Form for Protocol Review
3. LCPIERB Form 2 (C) - 2018 :  Checklist Form
4. LCPIERB Form 2 (D) - 2015 :  Protocol Summary Sheet
5. LCPIERB Form 2 (E) - 2018 :  Protocol Evaluation Form
6. LCPIERB Form 2 (F) - 2015 :  Informed Consent Evaluation Form
7.  LCPIERB Form 2 (G) - 2015  :  Protocol Document Review Form
  8.  LCPIERB Form 2 (H) - 2018  Checklist for Clinical Trial Outside LCP by LCP PI 
  9. LCPIERB Form 2 (I) - 2018 :  Checklist for Clinical Trial Outside LCP by Non-LCP PI
  10.  LCPIERB Form 2 (J) - 2018  Certificate of Exemption from Review 
  11.  LCPIERB Form 2 (K) - 2018  Protocol Resubmission Form 
       
III.  SOP 3 - Standard Operating Procedures (Post Approval Procedures) 
1. LCPIERB Form 3 (A) - 2018 :  Serious Adverse Event Report Form
2. LCPIERB Form 3 (B) - 2018 :  Protocol Amendment Application Form
3. LCPIERB Form 3 (C) - 2018 :  Continuing Review Application / Progress Report Form
4. LCPIERB Form 3 (D) - 2018 :  Study Protocol Non-Compliance Report Form
5. LCPIERB Form 3 (E) - 2018 :  Request/Query/Complaints Report Form
6. LCPIERB Form 3 (F) - 2018 :  Early Study Termination Application Form
7. LCPIERB Form 3 (G) - 2018 :  Site Visit Report Form
8. LCPIERB Form 3 (H) - 2018 :  Final Report Form
IV.  SOP 4 - Standard Operating Procedures (Documentation and Archiving) 
1. LCPIERB Letter 4 (A) - 2018 :  Notice of Review
2. LCPIERB Letter 4 (B) - 2018 :  Acknowledgment Letter
3. LCPIERB Template 4 (C) - 2014 :  Notice of Meeting
4. LCPIERB Template 4 (D) - 2018  :  Minutes of the Meeting
5. LCPIERB Form 4 (E) - 2018 Protocol Document Review Form
6. LCPIERB Form 4 (F) - 2018 :  Informed Consent Evaluation Form
7. LCPIERB Letter 4 (G) - 2018 :  Notification of LCPIERB Decision
8. LCPIERB Letter 4 (H) - 2018 :  Approval Letter to the Study Protocol
9. LCPIERB Letter 4 (I) - 2014 :  Notice of Site Visit
10. LCPIERB Letter 4 (J) - 2018 :  Reminder Letter for Continuing Review/Final Report
11. LCPIERB Letter 4 (K) - 2018 :  Action Letter (Request Information) to Continuing Review Application/Final Report/ Study Protocol Non-compliance Report/SAE Report/Early Study Termination Report/ Site Visit
12. LCPIERB4 Letter (L) - 2018 :  Action Letter to Study Protocol Resubmission/Amendments
13. LCPERB4 Letter (M) - 2018 :  Approval Letter to the Study Protocol Amendment Application
14. LCPIERB4 Letter (N) - 2018 :  Notification Letter for Continuing Review Application / Study Protocol Non-Compliance Report / SAE and SUSAR Report / Site Visit Report
15. LCPIERB Letter 4 (O) - 2014 :  Archiving Notification
16. LCPIERB Form 4 (P) - 2013  :  Borrowers Log
  17. LCPIERB Form 4 (Q) - 2018 Letter of Exemption from Ethical Review
  18. LCPIERB Letter 4 (R) - 2018 Confidentiality Agreement for Guests/Observers Form