Transcription of Standard Operating Procedures - Tata Memorial Centre
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Standard Operating Procedures - Tata Memorial Centre
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Approval of new and revised Implement, distribute and file all and request for a revision of an existing and archive superseded SOPs10 References11 Glossary12 List of AnnexureAX 1 V1/SOP01/V1 List of SOPs of Ethics Committee for13 Research on Human SubjectsAX 2 V1/SOP01/V1 Template for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.
AX1 V1SOP09/V2 Review Report for SAE Serious Adverse Event 160 AX2 V1SOP09/V2 Off site SAE Classification Form 163 AX3 V1SOP09/V2 Off Site SAE Log Report 164 Flow charts 165-166 Chapter 10 Maintenance of Active Project Files, Archival of Closed Files 167 and Retrieval of documents 10.1 Purpose 169 10.2 Scope 169 10.3 Responsibility 169
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