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_______________________________________\nSignature:  ___________________________________\tDate:  __________\nSite Representative:\nName:  _______________________________________\nSignature:  ___________________________________\tDate:  __________\n\u000f\nTable of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc534633599\" \u0014Table of Contents\t\u0013 PAGEREF _Toc534633599 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633600\" \u00141.0\tLIST OF ABBREVIATIONS\t\u0013 PAGEREF _Toc534633600 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633601\" \u00142.0\tINTRODUCTION\t\u0013 PAGEREF _Toc534633601 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633602\" \u00143.0\tMONITORING COMMUNICATION PLAN\t\u0013 PAGEREF _Toc534633602 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633603\" \u00143.1\tEmail Distribution\t\u0013 PAGEREF _Toc534633603 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633604\" \u00144.0\tVISIT SCHEDULING\t\u0013 PAGEREF _Toc534633604 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633605\" \u00145.0\tESSENTIAL DOCUMENTS/TRIAL MASTER FILE\t\u0013 PAGEREF _Toc534633605 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633606\" \u00145.1\tRequired Essential Documents\t\u0013 PAGEREF _Toc534633606 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633607\" \u00145.2\tMonitor’s Role in Essential Document Maintenance\t\u0013 PAGEREF _Toc534633607 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633608\" \u00146.0\tMONITORING REPORTS / ACTION ITEMS\t\u0013 PAGEREF _Toc534633608 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633609\" \u00147.0\tTYPES OF VISITS AND MONITORING ACTIVITIES\t\u0013 PAGEREF _Toc534633609 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633610\" \u00147.1\tSite Initiation Visit Activities\t\u0013 PAGEREF _Toc534633610 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633611\" \u00147.2\tInterim Monitoring Visit Activities\t\u0013 PAGEREF _Toc534633611 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633612\" \u00147.3\tFor-cause Visit Activities\t\u0013 PAGEREF _Toc534633612 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc534633613\" \u00147.4\tClose-out Visit Activities\t\u0013 PAGEREF _Toc534633613 \\h \u001417\u0015\u0015\n\u0015LIST OF ABBREVIATIONS\n{Add, delete or modify abbreviations as necessary per study protocol. It is recommended that abbreviations be listed alphabetically.}\nAE\tAdverse Event\nCFR\tCode of Federal Regulations\nCMP\tClinical Monitoring Plan\nCOV\tClose-Out Visit\nCRA\tClinical Research Associate\nCRF\tCase Report Form\nDSMB\tData Safety Monitoring Board\neCRF\tElectronic Case Report Form\nEDC\tElectronic Data Capture\nED\tEssential Documents\nFDA\tFood and Drug Administration\nGCP\tGood Clinical Practice\nICH\tInternational Conference on Harmonisation\nIMV\tInterim Monitoring Visit\nIRB\tInstitutional Review Board\nISF\tInvestigator Site File\nMOP\tManual of Procedures\nPI \tPrincipal Investigator\nSAE\tSerious Adverse Event\nSC\tStudy Coordinator\nSIV\tSite Initiation Visit\nSOP\tStandard Operating Procedures\nTMF\tTrial Master File\nUP\tUnanticipated Problem\n\u000f{Add, delete, or modify headings as needed in order to best reflect your study.  Abbreviations may need to be revised throughout the document as text is added or deleted.}\nINTRODUCTION\n{Briefly describe the purpose of the CMP.  Include additional information as it relates to the CMP (e.g., changes in PI, changes in clinical research management, protocol amendments).}\n{The sentence listing “monitoring tasks performed in accordance with” should be modified to reflect a regulated or non-regulated study. Currently language reflects a regulated study.}\nThe Clinical Monitoring Plan (CMP) establishes the guidelines for conducting monitoring visits and related tasks for monitoring Protocol \u003Cprotocol number, protocol title>.  Assigned Clinical Research Associate(s) (CRA(s)) will perform monitoring tasks in accordance with the protocol specific requirements, Title 45, Part 46 of the Code of Federal Regulations (CFR), the International Conference on Harmonisation (ICH) Good Clinical Practice Guidelines (GCP), The Code of Federal Regulations Part 312, and other applicable requirements.\nMONITORING COMMUNICATION PLAN\n{Describe the process for distributing monitoring communication. 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