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The tool guides customization to protocol needs, the study’s specific circumstances, and the capabilities of the chosen data capture platform. It specifies review and approval elements, including correctly setting CDMP version and date, and provides structured sections for the EDC process, from setup verification and validation alerts to data entry, cleaning, medical coding, reporting, reconciliation, closure, and archiving. Instructional placeholders are clearly identified for deletion or replacement.","Tool Summary Sheet\nTool:\tClinical Data Management Plan Template – External Facing\nPurpose:\tThis Clinical Data Management Plan (CDMP) template may be employed for studies using an Electronic Data Capture System (EDC), unless another template has been agreed upon.\nAudience/User:\tLead Data Managers and Principal Investigators of studies using Electronic Data Capture Systems\nDetails:\tThe template should be customized to the protocol, the study’s special needs / circumstances, and the requirements of the data capture system. Sections may be edited or deleted as needed.\nAs an alternative to this detailed template, individuals may prefer to reference the ‘Data Management Considerations (Condensed)’ tool, which is available in NIDCR’s Toolkit for Clinical Researchers (\u0013 HYPERLINK \"https://www.nidcr.nih.gov/research/human-subjects-research/toolkit-and-education-materials\" \\o \"Toolkit & Educational Materials \" \u0014http://nidcr.nih.gov/research/toolkit\u0015). This considerations tool lists important issues to consider when evaluating a group’s ability to electronically capture and validate clinical research data, and summarizes the wide array of data management tasks required.  The tool could also be used to suggest headings and content for a simplified clinical data management plan.\nBest Practice \u000bRecommendations:\n\u000eItems in blue italics and enclosed in braces { } are instructional text that should be deleted prior to approval.\nItems enclosed in single \u003C> are placeholders.  Replace as clarified in the enclosed text.\nReferences to “Sponsor” may refer to the funding sponsor or to the study PI, depending on the context of the sentence and on the decisions at the time of CDMP development.  Update the template at the time of implementation to refer to the appropriate party.\nPlease retain the CDMP Template identifier in the lower left hand section of the footer.\nRemove this Tool Summary Sheet prior to use of this template.\nTool Revision History:\nVersion\nClinical Data Management Plan\nProtocol Title: \u003CProtocol Title>\nProtocol Number: \u003C#>\nSummary of Changes:\nVersion\nClinical Data Management Plan\nProtocol Title: \u003CProtocol Title>\nProtocol Number: \u003C#>\nAPPROVAL SIGNATURES\n{Ensure that the CDMP version number and date are correct before providing the document to the primary signatory.}\n_______________________________________________________\t____________________\nPrincipal Investigator: \u003CName, Affiliation>\tDate\n______________________________________________________\t____________________\nProject Data Manager: \u003CName, Affiliation>\tDate\nTABLE OF CONTENTS\n\u0013 TOC \\o \"1-2\" \\h \\z \u0014\u0013 HYPERLINK \\l \"_Toc471471355\" \u0014APPROVAL SIGNATURES\t\u0013 PAGEREF _Toc471471355 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471356\" \u0014TABLE OF CONTENTS\t\u0013 PAGEREF _Toc471471356 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471357\" \u0014ABBREVIATIONS AND DEFINITIONS\t\u0013 PAGEREF _Toc471471357 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471358\" \u0014DYNAMIC REFERENCES\t\u0013 PAGEREF _Toc471471358 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471359\" \u00141\tIntroduction\t\u0013 PAGEREF _Toc471471359 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471360\" \u00142\tThe Electronic Data Capture (EDC) System and the Underlying Clinical Database\t\u0013 PAGEREF _Toc471471360 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471361\" \u00143\tNetwork Directories\t\u0013 PAGEREF _Toc471471361 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471362\" \u00144\tData Validation Process\t\u0013 PAGEREF _Toc471471362 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471363\" \u00144.1\tUnivariate Alerts\t\u0013 PAGEREF _Toc471471363 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471364\" \u00144.2\tMultivariate and Cross-module Alerts\t\u0013 PAGEREF _Toc471471364 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471365\" \u00145\tVerification of EDC Setup and Implementation\t\u0013 PAGEREF _Toc471471365 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471366\" \u00145.1\tSystem Specifications\t\u0013 PAGEREF _Toc471471366 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471367\" \u00145.2\tUser Acceptance Testing\t\u0013 PAGEREF _Toc471471367 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471368\" \u00146\tData Entry and Data Cleaning\t\u0013 PAGEREF _Toc471471368 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc471471369\" \u00146.1\tPre-requisites for Site Data Entry\t\u0013 PAGEREF _Toc","cbCaioNXQSGXiBQ3","https://ap.wps.com/l/cbCaioNXQSGXiBQ3","docx",74588,29,"English","en",105,"# APPROVAL SIGNATURES\n# TABLE OF CONTENTS\n## ABBREVIATIONS AND DEFINITIONS\n## DYNAMIC REFERENCES\n## 1 Introduction\n## 2 The Electronic Data Capture (EDC) System and the Underlying Clinical Database\n## 3 Network Directories\n## 4 Data Validation Process\n## 5 Verification of EDC Setup and Implementation\n## 6 Data Entry and Data Cleaning\n## 7 Loading Electronic Files\n## 8 Medical Coding\n## 9 EDC Exported Database\n## 10 Reports\n## 11 SAE Reconciliation\n## 12 Changes to a Production EDC\n## 13 Database Closure\n## 14 Data Archiving and Provision of Final Materials to Sponsor","[{\"question\":\"Who is the primary audience for this Clinical Data Management Plan template?\",\"answer\":\"Lead Data Managers and Principal Investigators for studies using Electronic Data Capture systems.\"},{\"question\":\"What should be customized before using the template?\",\"answer\":\"The template should be tailored to the protocol, the study’s specific needs and circumstances, and the requirements of the data capture system.\"},{\"question\":\"What items must be checked prior to obtaining primary approval?\",\"answer\":\"Ensure the CDMP version number and date are correct before providing the document to the primary signatory.\"}]","Clinical Data Management Plan Template - 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