Basic Documents (must submit):  1. Printed Registration and Application Form (Form 02. Fill-out all items, put N/A if not applicable).  2. Cover Letter (request letter for review addressed to the IRB Chair signed by the Principal Investigator and noted by the Department Chairman).  3. Study Protocol (attached is the sample content/format).  4. Curriculum Vitae of PI and study team members (Updated resume).  5. Good Clinical Practice (GCP) Training Certificate of PI, Co-I and the study team.  6. Electronic copy of study documents.  7. Study Budget (include honorarium of the investigators, compensation to subjects, operational expenses & no. of subjects for recruitment). Study-specific Documents (submit as needed):  1. Data collection forms / Case Report Forms / Questionnaires / Survey Forms (Any tool (validated) that will be used in the study).  2. Patient Information Form and  3. Informed Consent Form (ICF) in English and Tagalog (for studies with human participants). It should conform w/ the guidelines set by the Phil. National Ethical Guidelines on Health Research 2011.  4. Assent form in English and Tagalog (for studies involving minors and relevant populations deemed incompetent to sign an informed consent form).  5. Investigator’s Brochure (for Phase I, II, III) or Basic Product Information Document (for clinical trials phase IV); Published literature/medical device information (for Drug Trials only).  6. Recruitment advertisements and/or other information or documents for participants (such as diaries, etc. as needed by the study protocol).  7. Memorandum of Agreement (for collaborative studies).  8. List of other sites (local and international) & assigned Principal Investigators (for multicenter global clinical trials (with contact numbers and address).  9. PFDA Approval Letter (certification that study has been approved by the Phils. Food & Drug Adm.).  10. PFDA Certificate of Product Registration (for use of marketed study drug) or PFDA Import Permit (for use of study drug that is not yet Philippines Food & Drug Administration registered).

A. General Policy in Review of Research Protocols and Clinical Trials The JRRMMC IRB-IEC will review all research that will use the name of Jose R. Reyes Memorial Medical Center, its patients, personnel, and facilities. Its main purpose is to “help safeguard the dignity, rights, safety, and well-being of all actual or potential research participants” (WHO, 2000). B. Classifying Protocols for Review Research protocols may be classified/reviewed as (The IRB Chair shall determine the type of review): 1. Full Board Review: The Protocol is discussed fully during the IRB meeting before final action on the protocol is decided. a. if research study involves more than minimal risks to subjects. b. all new/initial submissions will undergo a full board review. 2. Expedited Review – protocol is reviewed within 2 weeks after submission: a. if research study involves no more than minimal risks to subjects and; i. Retrospective and case report studies b. for minor changes in resubmissions and/or in approved research (i.e. chart review, survey of non-confidential nature) c. for chart review, submit a waiver letter for the informed consent, a non-disclosure agreement, and permission to access medical charts/records. C. Schedules: 1. Cut-off date of Submission – every 20th day of each month (for full board) 2. For retrospective and case report studies, every Friday. 3. Schedule for Review - Every 2nd Wednesday of the month during the IRB Meeting. 4. Final Decision – this will be given within 7-14 days after the full board meeting. D. Formatting: All protocols must be submitted in: • A4 bond paper size; Font – Arial 12 pt.; Spacing – double-spacing throughout, except partly in the title page. • Start a new page for each of the main sections. • All pages should be consecutively numbered, beginning with the title page. Type the page number followed by the total number of pages in the lower right corner (e.g. p. 1 of 20). • Include a footer (in all pages) that indicates both the date (creation date) and version number of the protocol; for initial submission it should be zero (e.g. Protocol version 0 Title Date) o For the resubmitted protocol: Ref. No. v1 Title Date. (2018-001 v.1 Retinoblastoma April 12, 2017) E. For initial submission: 1 set – original copy - placed in a black hard binder; 4 sets – evaluation form (p. 4 of the application form). F. For Resubmissions: 1 set of protocol and 3 sets of the Summary of Revision form The modifications required including amendments initiated by the sponsor should be in accordance with the following: 1. Integrate the corrections to the protocol and/or consent forms and related documents. 2. Itemized the modification/s with page number using the Summary of Revision form. Modified part in the revised protocol should be underlined and bold. Submission should in .pdf format following the table of contents. All submission including cover letters should be complete and with signatures and send to This email address is being protected from spambots. You need JavaScript enabled to view it. Addressed your cover letter to: MICHELLE Y. OTAYCO, MD Chairperson, IRB Jose R. Reyes Memorial Medical Center Send all requirements in .pdf format according to this arrangement: IRB Application Form Cover Letter with signature of Principal Investigator and Department Chair TABLE OF CONTENTS Title Page Table of Contents Study Title & Authors Abstract I. Introduction 11. Objectives Ill. Review of Related Literature IV. Research Design V. Methodology VI. Study Subjects a. Inclusion Criteria b. Exclusion Criteria VII. Assessment Instruments VIII. Data Collection IX. Statistical/Data Analysis Plan a. Sample Size Calculation b. Data Analysis X. Limitations of the Study XI. Disclosures XII. Ethical Considerations XIII. Data Protection Plan XIII. Budget Proposal XIV. Schedule of Activities/Gantt Chart XV. Bibliography XVI. Appendices a. APPENDIX A. Database and Data Collection Form b. APPENDIX B: Patient Information Sheet English and Tagalog c. Informed Consent Form English and Tagalog d. APPENDIX D: Curriculum Vitae e. APPENDIX E: Good Clinical Practice Certificate