SOP MHREC 1 Sep 2019

Chapter 4 Meeting conduct, Documentation, and Archiving o Date borrowed o Name of borrower o Signature of borrower upon retrieval o Signature of MHREC Secretariat upon return of document to the file folder o Document copied o Number of copies made o Number of copies received • All requests for access are recorded by the Secretariat Staff in the log before copies of any documents are released. 4.7.5.4. Supervise the use of retrieved confidential document • Access to EC documents is generally for room use only, but requests to make copies can be accommodated on a case to case basis. • The Secretariat makes only the exact number of copies requested. • The recipient signs the MHREC log upon receipt of the copies. 4.7.5.5. Return document to the protocol file folder The EC secretariat Staff is responsible for returning the documents in the protocol file folder in the storage cabinet after making sure that all documents are complete as per Protocol File Index. 101

Chapter 4 Meeting conduct, Documentation, and Archiving Appendix D Documentation and Archiving Forms Form 4.1 Template of Meeting Agenda Form 4.2 Template of Meeting Minutes Form 4.3 MHREC Decision and notification for initial protocol submission, Form 4.4 MHREC Decision and notification for resubmission submission Form 4.5 MHREC Decision and notification for amandment submission Form 4.6 MHREC Decision for Progres report Form 4.7 MHREC Decision for Final report Form 4.8 Notification MHREC Decision (review of progress report) Form 4.9 Notification MHREC Decision (review of final report) Form 4.10 Template of Approval Letter Form 4.11 Template of Exemption Letter Form 4.12 Template of Amendment Approval letter Form 4.13 Template of Continuing Review Approval letter Form 4.14 Template of Document Request Form 4.15 Table of contents of protocol related documents files Form 4.16 Log of Requested MHREC Documents 102

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.1 Template of Meeting Agenda Meeting agenda Agenda number : Panel number : Type of Meeting Date of Meeting : Full-board Meeting Room : Time of Meeting : : MEETING TOPICS: 1. Approved protocols in the Last Meeting Minutes ( see previous meeting minutes) 2. New Protocols Expedited protocols No. Protocol Protocol Title Sponsor Principal Investigator Reviewers Number 1. 2. Full-board protocols Sponsor Principal Investigator Reviewers No. Protocol Protocol Title Number 3. 4. 3. Protocol Resubmission Sponsor Principal Investigator Reviewers No. Protocol Protocol Title 1. Number 2. 4. Protocol Amendment Sponsor Principal Investigator Reviewers No. Protocol Protocol Title 1. Number 2. 5. Continuing Review Sponsor Principal Investigator Reviewers No. Protocol Protocol Title 1. Number 2. 6. Progress Reports Sponsor Principal Investigator Reviewers No. Protocol Protocol Title 1. Number 2. 7. SAE Reports 103

Chapter 4 Meeting conduct, Documentation, and Archiving No. Protocol Protocol Title Sponsor Principal Investigator Reviewers Number 1. 2. 8. Site visit/Monitoring Reports Sponsor Principal Investigator Reviewers No. Protocol Protocol Title 1. Number 2. 9. Final Reports Protocol Title Sponsor Principal Investigator Reviewers No. Protocol 1. Number 2. 10. Protocol Violation/Deviation Report Sponsor Principal Investigator Reviewers No. Protocol Protocol Title 1. Number 2. 11. Other Issues 104

Minutes Number : Chapter 4 Meeting conduct, Documentation, and Archiving Full-board Meeting FORM 4.2 Meeting Room and location : Template of Meeting Minutes Time of Meeting : List of Attendees: Minutes of Meeting 1. Meeting’s Date: 2. 3. Panel number : 4. 5. 6. 7. Quorum (Y/N) 8. 9. 10. Conflict of Interest Addressed and Names 1. Approval of in the Last Meeting Minutes Principal Date of Decisions Investigator Approval No Protocol Protocol Title Sponsor [ ] Expedited Number [ ] Full-board review 2. Report of Expedited Review Sponsor Principal Reviewers Decisions No Protocol Protocol Investigator Number Title 1. o Approved 2. o Minor revision 3. New Protocol o Major revision No Protocol Number o Disapproved o Go to Full-board Protocol Title Sponsor Principal Reviewers Investigator Topics: Discussion: Conclusion Methodology: 1. Study design 105 2. Sample (size, how to acquire, exclusion and inclusion criteria) 3. Site 4. Time of research

Chapter 4 Meeting conduct, Documentation, and Archiving Ethical issues: 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc Decision: 4. Protocol Resubmission No Protocol Protocol Sponsor Principal Reviewers Decision Investigator Number Title o Approved o Minor revision o Major revision o Disapproved o Go to Full-board Topics: Discussion: Conclusion Methodology: 1. Study design 2. Sample (size, how to acquire, exclusion and inclusion criteria) 3. Site 4. Time of research Ethical issues: 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc 106

Chapter 4 Meeting conduct, Documentation, and Archiving 5. Protocol Amendment No Protocol Protocol Sponsor Principal Reviewers Decision Investigator Number Title o Approved o Minor Revision Topics: Discussion: o Major Revision Methodology: o Disapproved 1. Study design o Request additional 2. Sample (size, how to acquire, information exclusion and inclusion criteria) Conclusion 3. Site 4. Time of research Ethical issues: 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc 6. Continuing Review Sponsor Principal Reviewers Decision No Protocol Protocol Investigator Number Title o Renew approval Discussion: o Request additional Topics: Methodology: information 1. Study design o Recommend modification o Suspend: o enrollment of new subjects o research procedures in currently enrolled subjects o entire study o Disapprove renewal Conclusion 107

Chapter 4 Meeting conduct, Documentation, and Archiving 2. Sample (size, how to acquire, exclusion and inclusion criteria) 3. Site 4. Time of research Ethical issues: 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc 7. Progress Reports Sponsor Principal Reviewers Decision No Protocol Protocol Investigator □ Acknowledged/Accepted Number Title □ Request for further information, specify Topics: Discussion: □ Recommend further Methodology: action, specify 1. Study design □ Pending, if major 2. Sample (size, how to acquire, clarifications are required before a decision can be exclusion and inclusion criteria) made 3. Site Conclusion 4. Time of research Ethical issues: 108 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations

Chapter 4 Meeting conduct, Documentation, and Archiving 2. Budget 3. Material transfer etc 8. SAE Report Protocol Sponsor Principal Reviewers Decision No Protocol Title Investigator o Request an amendment to Number the protocol or the consent form Topics: Discussion: Request further Methodology: information 1. Study design o Suspend enrollment of 2. Sample (size, how to acquire, new research participant Suspend all trial-related exclusion and inclusion criteria) procedures 3. Site o Termination of the study 4. Time of research o Take note and continue Ethical issues: monitoring 1. Vulnerable subjects o Conduct study site visit 2. Voluntary o Others 3. Risks and benefits 4. Confidentiality Conclusion 5. Compensation 6. Withdrawal criteria Reviewers Decision 7. Emergency care ICF Conclusion 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc 9. Site Visit/Monitoring Reports Principal No Protocol Protocol Sponsor Investigator Number Title Topics: Discussion: Methodology: 1. Study design 109

Chapter 4 Meeting conduct, Documentation, and Archiving 2. Sample (size, how to acquire, exclusion and inclusion criteria) 3. Site 4. Time of research Ethical issues: 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc 10. Final Report Protocol Sponsor Principal Reviewers Decision No Protocol Title Investigato Conclusion Number r o Acknowledged/Accepted o Request for further information, Discussion: specify o Recommend further action, specify o Pending, if major clarifications are required before a decision can be made Topics: Methodology: 1. Study design 2. Sample (size, how to acquire, exclusion and inclusion criteria) 3. Site 4. Time of research Ethical issues: 1. Vulnerable subjects 2. Voluntary 3. Risks and benefits 4. Confidentiality 5. Compensation 6. Withdrawal criteria 7. Emergency care ICF 1. Complete Information 2. Language and Comprehension 110

Chapter 4 Meeting conduct, Documentation, and Archiving 3. Voluntariness Other issues 1. Compliance with Regulations 2. Budget 3. Material transfer etc 11. Protocol Violation/Deviation Report Principal Reviewers Decision No Protocol Protocol Sponsor Investigator Number Title o Acknowledged– no further Discussion: information or action required Topics: o Additional information required – additional information is needed in order to properly evaluate the violation o Correction and/or corrective actions are required. The MHREC must specify the corrective measures to prevent harm to current and future research participants o Site visit needed Conclusion 12. Other Issues Discussion: Conclusion: No. Topics Reviewed by: Approved by: 1. 2. Prepared by: Date: Panel Secretary Panel Chairperson Date: Date: 111

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.3 MHREC Decision and Notification for initial protocol submission MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of review : automatically assigned Date of Full-board Review of Revised Application  Yes  No Date of Previous review: : automatically assigned Decision of the meeting/ expedited review:  Approved (AP)  Administrative Modification (AM)  Minor revision (MiR)  Major revisions /Full-Board  Request additional information  Disapproved No. MHREC FM UGM - Dr. Sardjito General Hospital members This is to inform you of the MHREC Decision related to the documents you have submitted: Items For Revision Revision/information required from the principal investigator Protocol Informed Consent Others Please submit the revised document within 7 days from receipt of the notice Signature: ………………………..… Panel’s Secretary …………………………………… Date:……………………. Panel’s Chairperson Date:…………………………….. 112

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.4 MHREC Decision and Notification for resubmission submission MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of review : automatically assigned Date of Full-board Review of Revised Application  Yes  No Date of Previous review: : automatically assigned Decision of the meeting/ expedited review:  Approved (AP)  Administrative Modification (AM)  Minor revision (MiR)  Major revisions /Full-Board  Request additional information  Disapproved No. MHREC FM UGM - Dr. Sardjito General Hospital members This is to inform you of the MHREC Decision related to the documents you have submitted: Items For Revision Revision/information required from the principal investigator Protocol Informed Consent Others Please submit the revised document within 7 days from receipt of the notice Signature: ………………………..… …………………………………… Panel’s Secretary Panel’s Chairperson Date:……………………. Date:…………………………….. 113

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.5 MHREC Decision and Notification for amendment submission MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of review : automatically assigned Date of Full-board Review of Revised Application  Yes  No Date of Previous review: : automatically assigned Decision of the meeting/ expedited review:  Approved (AP)  Administrative Modification (AM)  Minor revision (MiR)  Major revisions /Full-Board  Request additional information  Disapproved No. MHREC FM UGM - Dr. Sardjito General Hospital members This is to inform you of the MHREC Decision related to the documents you have submitted: Items For Revision Revision/information required from the principal investigator Protocol Informed Consent Others Please submit the revised document within 7 days from receipt of the notice Signature: ………………………..… …………………………………… Panel’s Secretary Panel’s Chairperson Date:……………………. Date:…………………………….. 114

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.6 MHREC Decision for Progres Report MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of review : automatically assigned Date of Full-board Review of Revised Application  Yes  No Date of Previous review: : automatically assigned Decision of the meeting/ expedited review: □ Renew approval Type of review □ Request additional information □ Recommend modification □ Suspend: □ enrollment of new subjects □ research procedures in currently enrolled subjects □ entire study □ Disapprove renewal Expedited Full Board Exempted No. MHREC FM UGM - Dr. Sardjito General Hospital members Signature: ………………………..… Panel’s Secretary …………………………………… Date:……………………. Panel’s Chairperson Date:…………………………….. 115

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.7 MHREC Decision for Final Report MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of review : automatically assigned Date of Full-board Review of Revised Application  Yes  No Date of Previous review: : automatically assigned Decision of the meeting/ expedited review: □ Acknowledged/Accepted Type of review □ Request for further information, specify □ Recommend further action, specify □ Pending, if major clarifications are required before a decision can be made Expedited Full Board Exempted No. MHREC FM UGM - Dr. Sardjito General Hospital members Signature: ………………………..… …………………………………… Panel’s Secretary Panel’s Chairperson Date:……………………. Date:…………………………….. 116

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.8 Notification MHREC Decision (review of progress report) MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of Submission : Progress Report This is to inform you of the MHREC Decision related to the documents you have submitted: Items For Revision Revision/information required from the principal investigator Protocol Informed Consent Others Please submit the revised document within 7 days from receipt of the notice MHREC Decision □ Renew approval □ Request additional information □ Recommend modification □ Suspend: □ enrollment of new subjects □ research procedures in currently enrolled subjects □ entire study □ Disapprove renewal MHREC Chair Person Name Signature Date 117

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.9 Notification MHREC Decision (Review of Final Report) MHREC Protocol no. : automatically assigned Sponsor Protocol no. (if applicable) : automatically assigned Submission Date : automatically assigned when the secretariat send Document Received Form Date of Initial Approval : automatically assigned Protocol Title : automatically assigned Principle Investigator : automatically assigned Type of Submission : Final Report This is to inform you of the MHREC Decision related to the documents you have submitted: Items For Revision Revision/information required from the principal investigator Protocol Informed Consent Others Please submit the revised document within 7 days from receipt of the notice MHREC Decision □ Acknowledged/Accepted □ Request for further information, specify □ Recommend further action, specify □ Pending, if major clarifications are required before a decision can be made MHREC Chair Person Name Signature Date 118

Chapter 4 Meeting conduct, Documentation, and Archiving Form 4.10 Template of Approval Letter ETHICS COMMITTEE APPROVAL Ref. No. : KE/FK/ /EC/20… Title of the Research Protocol : Document(s) Approved and : version Principle Investigator : Participating investigator(s) : Name of Medically : Responsible Physician(s) (if applicable) Date of Approval : (Valid for one year beginning from the date of approval) Institution(s)/place(s) of : research The Medical and Health Research Ethics Committee (MHREC) states that the document above meets the ethical principle outlined in the International and National Guidelines on ethical standards and procedures for researches with human beings. The Medical and Health Research Ethics Committee (MHREC) has the right to monitor the research activities at any time. The investigator(s) is/are obliged to submit: □ Progress report as a continuing review (state its due time) □ Report of any serious adverse events (SAE) □ Final report upon the completion of the study ……………………………………………………. ..................................................................... Panel’s chairperson Panel’s secretary Recognized by Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) 119

Chapter 4 Meeting conduct, Documentation, and Archiving Form 4.11 Template of Exemption Letter ETHICS COMMITTEE Exemption Letter Ref. No. : KE/FK/ /EC/20.. Title of the Research Protocol : Document(s) and version : Principle Investigator : Participating investigator(s) : Institution(s)/place(s) of : research The Medical and Health Research Ethics Committee (MHREC) states that the document(s) above qualify for exemption from review. ……………………………………………………. ..................................................................... Panel’s Chairperson Panel’s Secretary Recognized by Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) 120

Chapter 4 Meeting conduct, Documentation, and Archiving Form 4.12 Template of Amendment Approval letter AMENDMENT APPROVAL The Ethical Committee of Research in Medical Health, Faculty of Medicine, Public Health, and Nursing, has carefully reviewed the document (s): Title of the Research Protocol : Document(s) Approved and : version Reference Number of Ethical : Approval Letter Name of Principal Investigator : Name of Institution : And approved the submitted amendment of : 1. Name of document Version : Date : Yogyakarta, Panel’s Chairperson Recognized by Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) 121

Chapter 4 Meeting conduct, Documentation, and Archiving Form 4.13 Template of Continuing Review Approval letter CONTINUING REVIEW APPROVAL OF APPROVAL Ref: KE/FK/ /EC/20… Ref : KE/FK/ /EC/20… Title of the Research Protocol : Documents Approved : Principle Investigator : Participating Investigator(s) : 1. Date of Approval : Institution(s)/place(s) of : research The Medical and Health Research Ethics Committee (MHREC) states that the document above meets the ethical principle outlined in the International and National Guidelines on ethical standards and procedures for researches with human beings. The Medical and Health Research Ethics Committee (MHREC) has the right to monitor the research activities at any time. The investigator(s) is/are obliged to submit: □ Progress report as a continuing review : Annually □ Report of any serious adverse events (SAE) □ Final report upon the completion of the study Panel’s Chairperson Panel’s Secretary Recognized by Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) 122

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.14 Template of Document Request Name of Document requested: Code: Requested by: Date:  Chairperson  Secretariat  MHREC FM UGM Member  Secretariat staff  Authority  Others…………….. Purpose of the request: Approval of request by: Date: Retrieved by: Date: Returned by: Date: Archived by: Date: 123

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.15 Table of Contents of Protocol Related Documents Files Template No. CONTENTS CHECK DATE LIST RECEIVED 1 PROTOCOL NUMBER Y/N 2 PROTOCOL TITLE 3 PRINCIPAL INVESTIGATOR 4 CONTACT PERSON/SUPERVISOR 5 SPONSOR 6 REVIEWERS Type of Review  7 APPLICATION FORM  8 PROTOCOL SUMMARY  9 PRINCIPAL  INVESTIGATORS’S CV 10 RESEARCH TEAM AND  ASSIGNMENTS 11 SUPERVISORS APPROVAL SIGNATURE 12 INFORMED CONSENT FORM 13 REVIEWERS ASSESMENT FORM 14 RESUBMISSION LETTER 15 APPROVAL LETTER 16 AMANDMENT LETTER 17 PROGRESS REPORT 18 SAE REPORTS 19 PARTICIPANT QUERY 20 SITE VISIT REPORT 21 FINAL REPORT 124

Chapter 4 Meeting conduct, Documentation, and Archiving FORM 4.16 LOG OF REQUESTED MHREC DOCUMENTS # Document Requester Date Requested Retrieved by Archived by Returned Date 125

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline Supersedes: Previous MHREC SOPs Prepared by: MHREC SOP Team Reviewed by: MHREC Faculty of Medicine, Public Health and Nursing, Approved by: Universitas Gadjah Mada – Dr. Sardjito Hospital Dean of Faculty of Medicine, Public Health and Nursing, Effective date: Universitas Gadjah Mada and Director of Dr. Sardjito Hospital 1 September 2019 5. Writing and Revising SOPs 5.1. Writing SOPs 5.2. Revising SOPs 5.3. Preparation of Guidelines Appendix D Form 5.1. Document History Form 5.2. Log of SOP recipient Form 5.3. Request for revision of an SOP 126

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline 5.1. Writing SOPs 5.1.1. Purpose To describe the procedure for writing, reviewing, and distributing SOPs of the Medical and Health Research Ethic Commitee (MHREC) of Faculty of Medicine, Public Health and Nursing, UGM - Dr. Sardjito General Hospital 5.1.2. Scope This SOP provides instruction on how the SOPs of the MHREC of Faculty of Medicine, Public Health and Nursing UGM - Dr. Sardjito General Hospital are prepared. 5.1.3. Responsibility It is the responsibility of the chair to organize an SOP Team to formulate the SOPs of the EC. The SOP Team is an ad hoc committee composed of designated EC’s members and invited resource persons. The team is responsible for drafting new SOPs and revising existing SOPs when necessary. The team must follow existing institutional procedures when drafting SOPs in consultation with the secretariat and the chair. The team submits the draft of the SOPs to the chair. The chair convenes an EC meeting to review and finalize the SOPs’ draft and submit the final draft to the Dean of Faculty of Medicine, Public Health and Nursing UGM and the Director of Dr. Sardjito General Hospital Hospital for final approval. The secretariat is responsible for keeping all versions of SOPs and ensures that all EC members have access to current versions of SOPs to guide them in the performance of their functions. 5.1.4. Process Flow/Steps PERSON(S) No ACTIVITY RESPONSIBLE Chair 1 Appoint the SOP Team SOP Team 2 List all relevant SOPs SOP Team 3 Identify reference templates with corresponding layout SOP Team 4 Draft new SOPs and submit to chair Chair, members, 5 Review and finalize new SOP in an EC meeting and secretariat Dean and Hospital submit to the Dean/ Hospital Director director 6` Approved and sign the new SOPs Secretariat 7 Distribute approved SOPs and keep copies in the EC files 127

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline 5.1.5. Detailed instructions 5.1.5.1. Appoint an SOP Team  The chair appoints appropriate members who have thorough understanding of ethical review process to be part of the SOPs writing team, and invites resource person if needed.  The SOP Team receives an orientation from the chair regarding its duties and responsibilities.  The chair may organize SOP Team workshops to facilitate the drafting of the SOPs.  The SOP Team will list all relevant SOPs 5.1.5.2. Identify reference templates with corresponding layout  The SOP Team identify reference templates with corresponding layout -- it may be from SOPs of other ECs -- to guide the drafting of the SOPs.  The SOP has several chapter. Every chapter consists of :  Title  Purpose  Scope. The scope defines the extent of coverage of the chapter and its limitations  Responsibility. This part identifies the persons assigned to perform specific tasks during the implementation  Process Flow/Steps  Detailed Instructions which elaborates the steps outlined in the process flow  Standard forms and checklists to be used  Each chapter should be given a number and a title that is self-explanatory and is easily understood.  The SOP Document History describes the different versions of the document by version no., version date, and description of main changes. 5.1.5.3. Draft new SOPs and submit to the Chair. The SOP contain:  Title page  Approval page  Table of contents  Introduction – contains a statement of ethical principles that will guide the EC  Chapter 1 : Structure and Composition of the EC – describes the composition of REC membership with specific review functions  Chapter 2: Initial Review Procedures – describe types of review and initial review procedures  Chapter 3: Monitoring Procedures – describe how the REC monitor implementation of approved protocols  Chapter 4: Management of Meetings, Documentation and Archiving – describe administrative procedures that support the review functions  Chapter 5: Writing and Revising Standard Operating Procedures, and Preparation of Guideline – describes how to draft and revise SOP and guidelines  Document History 128

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline  Glossary and List of Acronyms  References The SOP Team submits completed SOP draft to the chair 5.1.5.4. Review and finalize new SOPs in an EC meeting and submit to the Dean of Faculty of Public Health and Nursing UGM and Director of Dr. Sardjito Hospital  The chair presents the draft SOPs during an EC meeting for the members to discuss and finalize the draft.  The chair submits the approved draft to the Dean of the Faculty Medicine, Public Health and Nursing, UGM and the Director of Dr. Sardjito Hospital 5.1.5.5. Approve and sign new SOPs  The Dean of the Faculty Medicine, Public Health and Nursing, UGM and the Director of Dr. Sardjito Hospital reviews and approves the SOPs by signing in the designated section.  The approved SOPs will be implemented after approval by the Dean of the Faculty Medicine, Public Health and Nursing, UGM and Director of Dr. Sardjito Hospital. 5.1.5.6. Distribute approved SOPs and keep copies in the EC files  The secretariat distributes the new SOPs softcopies to all members and the secretariat staffs.  The secretariat keeps the original signed copy in the office.  The secretariat also keeps master soft-file in the EC’s computers. 5.2. Revising SOPs 5.2.1. Purpose To describe the procedure for revising the SOPs of the Medical and Health Research Ethic Commitee (MHREC) of Faculty of Medicine, Public Health and Nursing, UGM - Dr. Sardjito General Hospital 5.2.2. Scope This SOP provides instructions on how to revise existing SOPs 5.2.3. Responsibility It is the responsibility of the EC members to suggest revisions of the existing SOPs The chair appoints an SOP Team, an ad hoc committee composed of designated EC members and invited resource persons. The team is responsible for revising relevant parts of the existing SOPs. The team must follow existing institutional procedures when drafting or editing SOPs and consult the secretariat and chair about revisions. The team submits the revised sections to the chair. 129

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline The Chair convenes a business meeting to review and finalize revised SOPs and submit the final draft to the Dean of the Faculty Medicine, Public Health and Nursing, UGM and Director of Dr. Sardjito Hospital for final approval. The secretariat is responsible for keeping all versions of SOPs and ensures that all EC members have access to the most current versions of the SOPs to guide them in the performance of their functions. 5.2.4. Process Flow/Steps PERSON/S RESPONSIBLE NO ACTIVITY Member/s 1 Propose to revise an SOP SOP Team 2 Revise existing SOPs Members 3 Review & discuss SOP revision in full Dean of the Faculty Medicine, board meeting Public Health and Nursing, UGM 4 Approved SOP Revision and Director of Dr. Sardjito Hospital 5 File and distribute revised SOP Secretariat 6 Retrieve and archive copies of superseded Secretariat SOP 5.2.5. Detailed Instructions 5.2.5.1. Propose to revise an SOP  SOPs are reviewed at least every three years and may be revised any time, as necessary by the EC.  When an SOP section does not cover what it should, or it does not follow new regulations, a revision may become necessary.  Any member of the ethics committee or secretariat staff who notices an inconsistency between SOPs or has any suggestions on how to improve a procedure should use the form 5.5 (Appendix D) to make a request to revise an SOP  A revision substantial enough to warrant major changes should be recorded as a new version of the SOP. Major changes are those that have substantial effect on procedures, definitions, requirements, and similar considerations. Minor changes, i.e. editorial, grammatical, or administrative changes that have no substantial effect on procedures, are not recorded as a new version. 5.2.5.2. Revise existing SOPs  If the committee agrees with the request, The chair appoints the SOP team or an EC member designated by the chair to draft the revision  If the committee doesn’t agree, the chair will inform the person who made the request of the decision.  The SOP team or the designated member prepares the draft of revisions. 5.2.5.3. Review and discuss SOP revision in a business meeting 130

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline  The chair convenes a business meeting across all panels to discuss the revisions and finalize the draft 5.2.5.4. Approved SOP Revision  The chair submits the final version of the revised SOP to the Dean of the Faculty Medicine, Public Health and Nursing, UGM and Director of Dr. Sardjito Hospital  The Dean of the Faculty Medicine, Public Health and Nursing, UGM and Director of Dr. Sardjito Hospital approves the revised SOP by signing on the appropriate SOP section.  The approved version of revised SOPs will be implemented from the date of approval by the Dean of the Faculty Medicine, Public Health and Nursing, UGM and Director of Dr. Sardjito Hospital. 5.2.5.5. File and distribute revised SOP  Upon approval, the secretariat distributes the revised SOPs to the EC members and the secretariat staffs  The secretariat changes the electronic copy of the SOP published in the EC’s website with the newly revised version.  The secretariat retains the original signed copy of the revised SOP in the office  The original copy of the superseded copy is transferred to the archive after the updating of the SOP Document History 5.2.5.6. Retrieve and archive copies of superseded SOP  The secretariat archives the superseded version of the SOP as part of the historical file maintained by the EC.  The word “SUPERSEDED” is stamped on the cover page of the superseded SOPs with the date of archiving, 5.3. Preparation of Guidelines 5.3.1. Purpose To describe the procedure to prepare a new guideline or update an existing one as well as the layout and format of each guideline 5.3.2. Scope This SOP applies to the MHREC of Faculty of Medicine, Public Health and Nursing UGM - Dr. Sardjito General Hospital guideline and their revised versions published and distributed by the EC. 5.3.3. Responsibility It is the responsibility of the MHREC of Faculty of Medicine, Public Health and Nursing UGM - Dr. Sardjito General Hospital secretariat or designated persons to prepare or revise the guidelines as and when the need arises. The designated persons will manage the preparation/revision of the guideline with the assistance of the secretariat. 131

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guideline 5.3.4. Process Flow/Steps PERSON/S NO ACTIVITY RESPONSIBLE Designated person(s) 1 Drafting the guideline MHREC chair, 2 Review, discuss and approve the new or the members Secretariat updated Guideline 3 Uploading the Guideline 5.3.5. Detailed Instructions 5.3.5.1 Drafting the Guideline  A Guideline should have the following format:  Guideline Number or identifier  Title  Purpose of the Guideline  Process Flow/Steps  Detailed Instructions which elaborates the steps outlined in the process flow  Standard forms and checklists to be used  Glossary and List of Acronyms (if necessary)  References 5.3.5.2 Review, discuss and approve the new or the updated Guideline  The chair presents the draft of the guidelines during an EC meeting for members to discuss and finalize the draft. 5.3.5.3 Uploading the Guideline The secretariat upload the guideline to the EC website 132

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guidelines FORM 5.1. DOCUMENT HISTORY Chapter Topic Previous Revised Date of Effective Description of and section version version Revision Date the main change 133

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guidelines FORM 5.2. LOG OF SOP RECIPIENTS No. Name of Recipients No. of Copies Signature Date 1 Prof . XX (Chairperson) 2 Dr. XXXX 134

Chapter 5 Writing and Revising Standard Operating Procedures, and Preparation of Guidelines FORM 5.3. REQUEST FOR REVISION OF AN SOP Please complete this form whenever a problem or a deficiency in an SOP is identified SOP version: Chapter and section: Title: Details of problems or deficiency in the SOP: Identified by : Date : Discussed in date (D/M/Y) : List of attendance : 1. __________________ 2. __________________ 3. etc SOP revision required:  Yes  No If yes, specify the revision : If no, why not? Date SOP re-finalized : Date SOP approved : Date SOP becomes effective: 135

Acronym GLOSSARY AND ACRONYM COI Conflict of Interest CRF Case Report Form CV Curriculum Vitae EC Ethics Committee GCP Good Clinical Practice ICF Informed Consent Form MHREC Medical and Health Research Ethics Committee PI Principal Investigator SAE Serious Adverse Event SOP Standard Operational Procedure SUSAR Suspected Unexpected Serious Adverse Reaction 136

GLOSSARY AND ACRONYM Glossary Meeting agenda A list of things to be done at a meeting, e.g. agenda of Confidentiality a full-board meeting Prevention of disclosure to other than authorized Confidentiality Agreement individuals, e.g. confidentiality of MHREC FM UGM - Dr. Sardjito General Hospital’s information and Conflict of Interest documents Sometimes called Secrecy or Nondisclosure Continuing review / agreements. An agreement designed to protect Progress report confidentiality of information Protocol Deviation/ Non- A situation in which a person has a private or personal compliance/ Violation interest sufficient to appear to influence the objective Quorum exercise of his or her duties. Potential conflicts of interest must be disclosed and managed as per policy. SAE initial report Reports that are required by the EC to be submitted by SAE follow up report the principal investigator to monitor the safety of the Independent consultant participants enrolled in a study. Deviation/ non compliance/ violation from what is Minutes stated in the approved protocol and its related Medical member documents. non-medical/non-scientific the minimum number of members of an assembly that member must be present at any of its meetings to make the On Site SAE proceedings of that meeting valid Off Site SAE The first report of the SAE, i.e. when the SAE is first Scientific member discovered The subsequent/ follow up report of an SAE already reported An expert who gives advice, comments and suggestion upon review of a study protocols with no affiliation to the institutes or investigators proposing the research protocols. The independent consultant is not involved in the decision making An official record of the business discussed and transacted at a meeting. Member who is a medical doctor nor a researcher Member who is neither a medical doctor nor a researcher SAE that occurred in the site where the protocol and its related documents is reviewed SAE that occurred outside the site where the protocol and its related documents is reviewed Member who is a based on or characterized by the methods and principles of science 137

REFERENCES 1. Badan Pengawas Obat dan Makanan, 2001, Pedoman Cara Uji Klinik yang Baik di Indonesia, Badan POM, Jakarta 2. Badan POM (Pengawas Obad dan Makanan) Republik Indonesia, 2014, Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor 9 Tahun 2014 tentang Tata Laksana Persetujuan Uji Klinik, Badan Pom, Jakarta 3. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health – related Research Involving Humans. CIOMS; 2016 4. Forum for Ethical Review Committees in Asia and the Western Pacific Region. FERCAP Standard Operating Procedures. 2005 5. International Conference on the Harmonisation. ICH Harmonized Tripartite Guideline for Good Clinical Practice. 1996. 6. International Ethical Guidelines for Epidemiological Studies. 7. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6 (R1) Step 5 2002. 8. National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, Good Clinical Practice, https://gcp.nidatraining.org/ 9. World Health Organization. Operational Guidelines for Ethics Committees that Review Biomedical Research. Geneva: 2000. 10. World Health Organization. Standards and Operational Guidance for Ethics Review of Health – related Research with Human Participants. 2011 11. World Medical Association Declaration of Helsinki. October 2013. 138