Task Distribution Checklst NIDCR Home任务分配表国立家.docVIP

Tool Summary Sheet Tool: Task Distribution Checklist Purpose: To identify who (at a group level) will be responsible for each of the various tasks associated with planning, executing, monitoring, analyzing, reporting, and archiving a clinical research study Audience/User: Lead Investigators, IND/IDE Holders (when applicable), and all others responsible for any of the delineated tasks on the list Details: This document identifies which group will be conducting each of the various study tasks but is not intended to be a legal transfer of sponsor obligations. As such, when an IND/IDE is obtained, the IND/IDE sponsor retains overall regulatory obligations for the study.The objective of this document is to ensure that all potential study responsibilities are considered and clearly assigned. Best Practice Recommendations: This document should be prepared early in a study to ensure that all responsibilities are clearly established. This tool can be edited to suit the needs and requirements of the study. You can indicate “Not applicable” or remove rows at your discretion. There are additional blank rows included for your convenience; add other responsibilities that may be important and/or unique to your study in these rows. All parties noted in the checklist should agree on the delineation of responsibilities and receive a copy of the completed document. This is not intended to replace the Delegation of Responsibilities Log, which differentiates site specific clinical responsibilities. Changes to the grid should be documented and the updated version should be made available to all responsible parties. If you are not using the services of CROMS (Rho), you can replace that column heading with the designation of the relevant Data Coordinating Center. Below are suggestions for completing the tables. Use the strategy that works best for your study. Insert “X” into cells in a row when one group is solely responsible for a task. In some cases, when multiple groups shar