Call for Public Comment
• Considerations and business models for using vendor-hosted EDC systems
• Common practices for training clinical investigational sites in the use of EDC
• Methods for managing system access and privileges
• Common steps in system set-up and testing
• Special considerations for data processing when using web-based EDC
• Common dynamic workflow and data flow options within web-based EDC systems
• Basic and common features of fields, forms and form groupings in EDC systems
• Similarities and differences between paper and web-based data collection
• The regulatory basis for practices in EDC implementation and study start-up
The revised edition of this chapter of the GCDMP covers:
This chapter reviews the implementation and start-up tasks for clinical studies using web-based EDC for form-based data collection and management. Topics covered include designing, developing, testing, and implementing workflow and data flow in clinical studies using EDC systems. Prior to the final publication, we are seeking your input on the draft chapter.
The 2020 edition of Electronic Data Capture – Implementation and Study Startup is now open for public review and comment.
DOWNLOAD DRAFT CHAPTER
How to submit your feedback:
• Download a comment sheet.
• As you read the draft chapter, record your comments in the columns provided.
• Email your completed comment sheet to [email protected]
COMMENT SHEET
Every comment will be read and resolved by the authors, so this is your opportunity to contribute your expertise to the revision project.
EDC-Implementation and Study Start-up will be open for public comment through March 30, 2020. The authors will host an online presentation to introduce the revisions and speak directly with clinical data managers with questions on Monday, March 2, 2020, at 10 am EST. Keep an eye on your inbox for more information!
REMINDER: The open comment period for Electronic Data Capture – Selecting an EDC System will close on February 10, 2020.
That leaves you just a few days more to offer your feedback on the 2020 revision prior to publication! You’ll find the draft chapter and comment sheet to download here at the SCDM.org.