ToolSummarySheet.docxVIP

Tool Summary SheetTool:Guideline: Study Start-up through Site Initiation Visit and Site Activation for Extramural Studies Requiring Additional NIDCR OversightPurpose:To clarify the Extramural study start-up process from protocol development through site initiation and activation. Explicitly included are studies requiring additional NIDCR oversight. Audience/User:Lead Investigators and study team members of Extramural studies supported by the NIDCR, the Clinical Research Operations and Management Support team (CROMS), and Program Officials of the NIDCRDetails:This document identifies prerequisites for a) the scheduling of a site initiation visit and b) site activation (i.e., the authorization to begin subject recruitment). Also discussed are other study start-up recommendations. Useful tools are referenced. Best Practice Recommendations:This guidance should be reviewed early in the protocol development process. Tools referenced in the guidance document should be reviewed early in the start-up process to determine those which are most useful and appropriate. Most tools are accompanied by a summary sheet that details the purpose of the tool, the audience for the tool, and best practices associated with the tool. Referenced tools are bolded, for convenience, and can be found on the CROMS website in the Clinical Tool Box section. Many are also located on the NIDCR’s Toolkit for Clinical Researchers website.Clinical research tasks must be conducted in accordance with Good Clinical Practice (GCP) in order to ensure human subject safety and data integrity.Tool Revision History:VersionNumberDateSummary of Revisions Made:1.023FEB2012Approved version2.019DEC2013Updated to reflect current risk/oversight process and policy, and revised/added definitions and references to existing tools and templates. Table of Contents1ABBREVIATIONS AND TERMINOLOGY42INTRODUCTION93PROTOCOL-RELATED AND STUDY ADMINISTRATION DOCUMENTS AND PROCESSES133.1Protocol and Consent/Assent Document Develop