A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan. (September 2015)

• Record Type: Journal Article
• Authors: Brand, Scott; Bartlett, Diana; Farley, Mary; Fogelson, Miriam; Hak, Jan Bart; Hu, Grace; Montana, Olivia D.; Pierre, Jan Holladay; Proeve, Johann; Qureshi, Samina; Shen, Anita; Stockman, Peter; Chamberlain, Richard; Neff, Kristin
• Is Part Of: Therapeutic innovation & regulatory science. Volume 49:Number 5(2015:Sep.)
• Page Start: 720
• Page End: 729
• Publication Date: 2015-09
• Subjects: data management plan -- standard operating procedure -- clinical trial -- electronic data capture -- case report form; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479015579520
• Languages: English
• ISSNs: 2168-4790

Abstract

Background: The DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data management plan. Methods: The goal of the committee was to develop a plan that could be used by industry and academic institutions. The model was based on contributed examples from committee members and their experiences with current practices and technologies. It is understood that as new clinical trial technology is implemented, the SOP will require modification. Results: The model SOP and associated templates are presented as a starting point, and each company or institution will need to modify them to meet its individual needs. Conclusion: The model DMP SOP produced addresses most data management issues that are present in any phase clinical trial while providing a flexible framework.