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Clinical Trial and Research

The Research Committee was created under Special Order No. 42 s. 1990 due to the need of the Institute for an advisory group who will conduct as well as supervise all research trials and exploratory studies. Since then, the Committee has been continuously upgraded in order to improve the Institute’s research endeavors. The most recent re-organization was under Special Order No. 16 s. 1999 changing the members of the Research Committee.

Objectives

• To coordinate researches being produced by all departments in order to produce relevant and accurate information on the diagnosis and treatment of kidney disease, and renal replacement including dialysis and transplantation, utilizing the clinical and laboratory materials of the Institute

• To ensure that researches conducted by the Institute have direct clinical application on the practice of medicine, especially in the field of renal medicine and transplantation.

Application for Research

• Researches can be conducted at the NKTI, whether single center or multicenter, when the primary investigator/s are current staff members of the Institute.

• The NKTI may enter into collaborative researches conducted outside the Institute after the required procedures for application are complied with.

• All hospital researches shall submit their research protocol to the Institutional Review Board (IRB) for approval prior to initiation of the study.

Guidelines for Submission of Research Protocol

Schedule of NKTI-IRB Meetings

Introduction

1. Standard Operating Procedures (Introduction)

SOP I

1. Standard Operating Procedures I (Research Ethics Committee Structure & Composition)
2. NKTIREC FORM 1.1: Letter of Appointment and Terms of Reference
3. NKTIREC FORM 1.2: Curriculum Vitae
4. NKTIREC FORM 1.3: Confidentiality and Conflict of Interest Agreement
5. NKTIREC FORM 1.4: Training Record of REC Member

SOP II

1. Standard Operating Procedures II (Types of Review)

SOP III

1. Standard Operating Procedures III (Initial Review Procedures)
2. NKTIREC FORM 3.1: Cover Letter for All Submissions to the NKTI REC Office
3. NKTIREC FORM 3.2: Application for Protocol Review
4. NKTIREC FORM 3.3: Protocol Summary Sheet
5. NKTIREC FORM 3.4-A: Protocol Evaluation
6. NKTIREC FORM 3.4-B: Informed Consent Evaluation
7. NKTIREC FORM 3.5: Notification of REC Decision
8. NKTIREC FORM 3.6: Approval Letter
9. NKTIREC FORM 3.7: Letter for Clarificatory Interview
10. NKTIREC FORM 3.8: Review of Resubmitted Protocol
11. NKTIREC FORM 3.9: Waiver of Consent
12. NKTIREC FORM 3.10: Letter Template for Application for Exempt from Ethical Review
13. NKTIREC FORM 3.11: Checklist for Exemption from Ethical Review

SOP IV

1. Standard Operating Procedures IV (Continuing Review)
2. NKTIREC FORM 4.1-A: Serious Adverse Event/s Report
3. NKTIREC FORM 4.1-B: Standard Adverse Drug Event/s Report
4. NKTIREC FORM 4.1-C: SAE Summary Report
5. NKTIREC FORM 4.2: Protocol Amendment Review
6. NKTIREC FORM 4.3: Continuing Review Report
7. NKTIREC FORM 4.4 Final Report
8. NKTIREC FORM 4.5: Protocol Non-Compliance/Violation/Deviation Summary Report
9. NKTIREC FORM 4.6: Early Study Termination
10. NKTIREC FORM 4.7 Reminder Letter for Continuing Review or Final Report

SOP V

1. Standard Operating Procedures V (Meetings)
2. NKTIREC FORM 5.1: Format for the Agenda of the Meeting

SOP VI

1. Standard Operating Procedures VI (Documentation & Management of Files and Archiving
2. NKTIREC FORM 6.1: Minutes of the Meeting
3. NKTIREC FORM 6.2: Submissions Log
4. NKTIREC FORM 6.4: Borrower's Log
5. NKTIREC FORM 6.5-A: Confidentiality Agreement for Guests and Observers
6. NKTIREC FORM 6.5-B: Log of Requests for Copies of Documents
7. NKTIREC FORM 6.5-C: Confidentiality Agreement Form for Non-Members Requesting to Access NKTIREC Documents
8. NKTIREC FORM 6.6: Research Ethics Committee (REC) Tracking Form

SOP VII

1. Standard Operating Procedures VII (Site Monitoring)
2. NKTIREC FORM 7.0: Site Visit Report

SOP VIII

1. Standard Operating Procedures VIII (Management of Requests, Queries, Complaints)
2. NKTIREC FORM 8.0: Requests, Queries, Complaints)

SOP IX

1. Standard Operating Procedures IX (Writing & Revising SOPs)

Abbreviations

Glossary

References

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