Data Management Plan Template - National Insti.DOCVIP

Tool Summary Sheet Tool: Clinical Data Management Plan Template – External Facing Purpose: This 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. Audience/User: Lead Data Managers and Principal Investigators of studies using Electronic Data Capture Systems Details: The 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. As 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 (/research/toolkit). 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. Best Practice Recommendations: Items in blue italics and enclosed in braces { } are instructional text that should be deleted prior to approval. Items enclosed in single are placeholders. Replace as clarified in the enclosed text. References 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. Please retain the CDMP Template identifier in the lower left hand section of the footer. Remove this Tool Summary Sheet prior to use of this template. Tool Revision History: Version Number Date Summary of Revisions Made: 1.0 12Jan2012 Approved version Clinical Data Management Plan Protocol Title: Protocol Title Protocol Number: # Version Number and Date: Version x.x,