Standard Operating Procedures - Tata Memorial Centre

1 Standard Operating ProceduresHuman Ethics CommitteeTata Memorial CentreTata Memorial HospitalDr Ernest Borgest Road,Parel, MumbaiContentsPage iiiContentsS. List of Acronymsxiv-xvChapter 1 Preparing Standard Operating Procedures (SOPs):5 Writing, Reviewing, Distributing & Amending SOPs for theHuman Ethics Committee (HEC), the need for new or amendment to the SOP of relevant a format and , Review and Approve by and submission of final Approval of new and revised Implement, distribute and file all and request for a revision of an existing and archive superseded SOPs10 References11 Glossary12 List of AnnexureAX 1 V1/SOP01/V1 List of SOPs of Ethics Committee for13 Research on Human SubjectsAX 2 V1/SOP01/V1 Template for SOP14 ContentsPage ivAX 3 V1/SOP01/V1 Document History of the SOP15AX 4 V1/SOP01/V1 Log of the HEC members receiving SOPs16AX 5 V1/SOP01/V1 Request for Formulation of new SOP/ Revision of an SOP 17AX 6 V1/SOP01/V1 Log of SOP Recipients18 Flow chart19 chapter 2 Constitution of Human Ethics Committee.

2 Ethical of / Replacement / Removal of Independent Roles and Responsibilities of the HEC Quorum Decision Education for HEC Prepare an annual activity report of the HEC for submission to the Director, TMC 32 References32 Glossary33S. No. TitlePg. vList of AnnexureAX1 V1/SOP02/V2 Confidentiality & Conflict of Interest Agreement34 Form for HEC MembersAX2 V1/SOP02/V2 Confidentiality Agreement Form for37 Independent ConsultantsAX3 V1/SOP02/V2 Confidentiality Agreement Form for Observer38 Attendees to HEC, TMC MeetingsFlow chart39 chapter 3 Management of Protocol submitted Contents of Submitted Detailed description of Study Project Submission Resubmission of Protocols with Research Protocol Amendments and other study related Annual Continuing Reviews of Approved Protocol Completion46 Reference46 Glossary46 List of AnnexureAX1 V1/SOP03/V2 Project Submission Application Form for Initial Review 47AX2 V1/SOP03/V2 Checklist of Documents64AX3 V1/SOP03/V2 Document Receipt Form65AX4 V1/SOP03/V2 Guidelines for devising ICF and Sample format67of an Informed Consent Child Information Sheet and Assent Form72 Flow Chart76 chapter 4 Initial Review of Submitted No.

3 TitlePg. Categorization of of Design and Conduct of the and Protection of Research of Research Participant Consent of Research the of study assessment the assessment AT HEC meeting84 References85 Glossary85 List of AnnexureAX1 V1 SOP04a/V2 Study Assessment Form87 Flow chart92 chapter 4b Expedited Review of Submitted Categorization of Expedited of between the HEC and the investigator97 Reference97 Glossary97 Flow chart98S. No. TitlePg. viiChapter 4c Exemption from the Ethical Review for Research Categorization of from of protocols eligible for exemption from between the HEC and the investigator103 Reference103 Glossary103 List of AnnexureAX1 V1/SOP04c/V2 Review Exemption Application Form104 Flow chart108 chapter 5 Agenda Preparation, Meeting Procedures and109 Recording of submitted Distribution of Protocol/ Documents Packages to the HEC Members for the the Making the HEC a Preparing the minutes and the decision b Approval of the minutes and the c Filing of the minutes of the Decision114 Reference115S.

4 No. TitlePg. viiiGlossary115 List of AnnexureAX1 V1/SOP05/V2 Agenda format116AX2 V1/SOP05/V2 Approval letter format117AX3 SOP05/V2 Format for Conditional Approval120 Flow chart121 chapter 6 Review of Amended protocol / Protocol related documents amended protocols/documents/ of amendments and notifications126 Reference126 Glossary126 List of AnnexureAX1 V1/SOP06/V2 Project Amendment/Document Amendment Approval letter 127AX2 V1/SOP06/V2 Amendment Reporting Form128 Flow chart129 chapter 7 Continuing review of study Determine the date of continuing the Principal Investigator or the study continuing review package upon the contents of the the continuing review the Members of the HEC135S. No. TitlePg. meeting Review original the HEC Decision to the Principal Investigator135 Reference136 List of AnnexureAX1 V1/SOP 07/V2 Continuing Review Application Form137AX2 V1/SOP 07/V2 Reminder letter by the HEC to investigator140AX3 V1/SOP 07/V2 HEC Decision on Continuing Review Report141AX4 V1/SOP 07/V2 Project Report Approval Letter142 Flow chart143 chapter 8 Reporting of Protocol Deviation / Non-Compliance / Violation / of Protocol deviation / non-compliance / Noting protocol deviation / non-compliance / violation by the Secretariat discussion, Decision, and Notify the and follow up to be kept by IRB secretariat149 References149 Glossary150 List of AnnexureAX 1 V1/SOP08/V2 Deviation / Non-Compliance / Violation /151waiver Reporting formFlow chart152 chapter 9 Review of serious adverse events (SAE) Responsibility155S.

5 No. TitlePg. Instructions155On site related activities before HEC to be taken by Member Secretary, to be taken by Chairperson, HEC156 Off Site the HEC the review of SAE158 References159 Glossary159 List of AnnexureAX1 V1 SOP09/V2 Review Report for SAE serious adverse Event160AX2 V1 SOP09/V2 Off site SAE Classification Form163AX3 V1 SOP09/V2 Off Site SAE Log Report164 Flow charts165-166 chapter 10 Maintenance of Active Project Files, Archival of Closed Files 167and Retrieval of Maintain the active study Disposal of closed Accessibility / Final Disposal of Master files170 Glossary170 List of AnnexureAX1 V1/SOP10/V2- Document Request Form171AX2 V1/SOP10/V2- Format of written off register172 Flow chart173S. No. TitlePg. xiChapter 11 Documentation of the HEC to HEC records177 Flow Chart178 chapter 12 Review of study completion each board and during board the board meeting181 References182 List of AnnexureAX1 V1/SOP 12/V2 Study Completion Report Form183 Flow Chart184 chapter 13 Management of Premature Termination / Suspension /185 Discontinuation of the study of the recommendation for study termination/187 and discuss the Termination / suspension/187discontinuation the the protocol documents188S.

6 No. TitlePg. xiiReferences188 List of AnnexureAX 1 V1/SOP13/V2 Premature Termination / Suspension /189 Discontinuation ReportFlow chart190 chapter 14 Request for Waiver of Written Informed Detailed Type of research projects which may qualify for consent waiver193 References195 List of AnnexureAX 1 SOP14/V2 - Application form for requesting waiver of consent196 Flow Chart197 chapter 15 Site of study the the the visit202 Glossary203 List of AnnexureAX1 V1/SOP15/V1 Site Monitoring Visit Report204 Flow chart206S. No. TitlePg. xiiiChapter 16 Dealing with participants / patients requests and complaints Detailed Filling the request document210 References210 List of AnnexureAX1 V1/SOP 16/V1 - Request Record Form211 Flow chart212 Appendices2131. Policy on Recruitment osf TMC Students and Staff2152. Policy on the Recruitment of Research Subjects2163. Policy on Research Costs to Subjects2174.

7 Guidelines on Compensation for Research Subjects2185. Policy on the Use of Third Party/Surrogate Consent in Research at TMC2196. Policy on Blood Withdrawal for Research Purposes2207. Guidelines and Policy on Informed Consent2228. Policy for Documentation of Informed Consent2249. Health Record Research22710. Guidelines for Research Protocols That Require Collection229and /or Storage of Genetic Materials11. Guidelines for Submission and EC Review of Gene Therapy /231 Gene Transfer Protocols12. Recommended Terms for Use in Consent Forms234S. No. TitlePg. of AcronymsPage xivList of AcronymsAcronymFull Title/DescriptionAAHRPPA ssociation for the Accreditation of Human Research Protection ProgramsACTRECA dvanced Centre for Treatment, Research and Education in CancerADRA dverse Drug ReactionAEAdverse EventAIIMS All India Institute of Medical SciencesASUA yurveda, Siddha, Bhabha Atomic Research CentreBEBio-equivalenceBISB ureau of Indian StandardsCDCC enter for Disease Control and PreventionCDSCOC entral Drugs Standard Control OrganizationCFRCode of Federal RegulationsCIOMSC ouncil for International Organizations of Medical SciencesCoIConflict of InterestCONSORT Consolidated standards of reporting trialsCRFCase Record FormCROC ontract Research OrganizationCRSC linical Research SecretariatCTAC linical Trial AgreementDAED epartment of Atomic EnergyDBTD epartment of BiotechnologyDCGIDrug Controller General of IndiaDCRD rugs and Cosmetic Rules.

8 1945 DGFT Directorate General of Foreign TradeDHHSD epartment of Health and Human Services DSMBData Safety Monitoring BoardDSMSC Data Safety Monitoring Sub CommitteeDTABD rugs Technical Advisory BoardList of AcronymsPage xvELSIE thical, Legal and Social IssuesFDAFood and Drug Administration FDCF ixed Dose CombinationFERCAPF orum for Ethical Review Committees in Asia and the Western Pacific RegionGCPGood Clinical PracticeGMPGood Manufacturing PracticesHECH uman Ethics CommitteeHIPAA Health Insurance Portability and Accountability ActHMSC Health Ministrys Screening CommitteeIAEA International Atomic Energy AgencyIBInvestigator s BrochureICFI nformed Consent FormICHI nternational Committee on HarmonizationICJMEI nternational Committee of Medical Journal EditorsICMR Indian Council of Medical ResearchIDEI nvestigational Device ExemptionIMDRA Indian Medical Devices Regulatory AuthorityINDI nvestigational New DrugIRBI nstitutional Review BoardISII ndian Standards InstituteMOU Memorandum of UnderstandingMTAM aterial Transfer AgreementNAC-SCRT National Apex Committee for Stem Cell Research and TherapyNCENew Chemical

9 EntityNDANew Drug ApplicationNIHN ational Institutes of HealthNOCNo-objection CertificateOHRP Office for Human Research ProtectionsPIPrincipal InvestigatorRCTR andomized Controlled TrialSAES erious adverse EventSOPsStandard Operating ProceduresSRCS cientific Review CommitteeTMCTata Memorial CentreTMHTata Memorial HospitalTRACTMC-Research Administration CouncilWHO World Health OrganizationWMA World Medical AssemblyPage 1 Human Ethics Committee, Tata Memorial Centre (HEC, TMC)SOP CodesSOP 01/V1, SOP 02/V2, SOP 03/V2, SOP 04a/V2, SOP 04b/V2, SOP 04c/V2,SOP05/V2, SOP 06/V2, SOP 07/V2, SOP 08/V2, SOP 09/V2, SOP 10/V2, SOP 11/V2 SOP, 12/V2, SOP 13/V2, SOP 14/V2, SOP 15/V1, SOP 16/V1 Authors:Name and Position on the HECS ignature with dateDr. Medha Joshi (Member Secretary HEC-II)Dr. Sangeeta Desai (Member Secretary HEC-I)Ms. Abhidnya Kandalkar (IRB Jr. Administrator)Approved by:Name and Position on the HECS ignature with dateMs.

10 Shirin Bharucha (Chairperson HEC I)Dr. Urmila Thatte (Chairperson HEC-II)Accepted by:Name and Position on the HECS ignature with dateDr. R. A. Badwe, Director, TMCPage 2 Reviewed by:Name and Position on the HEC - ISignature with dateDr. Geeta Koppikar, Co ChairpersonDr. Mistry, MemberDr. Nithya Gogtay, MemberMr. Gul Kripalani, MemberMs. Viji Venkatesh, MemberMs. Mrunal Marathe, MemberDr. Pradnya Talawadekar, MemberDr. S. K. Shrivastava, MemberDr. S. D. Banavali, MemberDr Narayan, MemberDr. Parul J. Shukla, Member &Jt. Secretary, DSMSCDr. A. Gajiwala, MemberDr. Vikram Gota, Alternate MemberPage 3 Reviewed by:Name and Position on the HEC-IISignature with dateDr. R. F. Chinoy, Co-ChairpersonDr. Joshi, MemberDr. R. Munagekar, MemberMr. Rao, MemberMs. Tessie George, MemberDr. Reena Nair, MemberDr. A. Puri, Member, &Jt. Secretary, DSMSCDr. Muckaden, MemberDr. Pai, MemberSOP 01/V1 Effective Date: , TMCP reparing SOPs - Writing, Reviewing, Distributing & Amending SOPs for Human Ethics Committee (HEC)Page 5 Human Ethics Committee, Tata Memorial Centre (HEC, TMC)Title:Preparing Standard Operating Procedures (SOPs): Writing,Reviewing, Distributing & Amending SOPs for the Human EthicsCommittee (HEC), TMCSOP Code: SOP 01/V1 Date : 01/09/2009 Pages: 16 SOP 01/V1 Effective Date: , TMCP reparing SOPs - Writing, Reviewing, Distributing & Amending SOPs for Human Ethics Committee (HEC)Page PurposeThis SOP defines the process for writing, reviewing, distributing, and amending SOPs within theHEC, SOPs will provide clear, unambiguous instructions to conduct activities of the HEC in accordancewith the ICMR guidelines 2006, Schedule Y (Drugs and Cosmetic Act 1940.)