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ACRP 2019 OnDemand

126 - The Evolution of Source Documents


Apr 14, 2019 3:15pm ‐ Apr 14, 2019 4:15pm



Credits: None available.

Non Member: $75.00
Members: $15.00

Description

This presentation is for a new coordinator or for coordinators who would like a refresher. The presentation will address the creation of comprehensive source documents and how to incorporate source documents within the electronic medical record system without creating more work. Source documentation is critical for obtaining accurate data. The number one cause of FDA 483s reported is that sites are not following the protocol. Therefore, developing well written source documents will provide detailed instructions on the information that must be collected. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation. Source documents should be organized in such a way that anyone is able to complete a visit without missing essential data points.

Learning Objectives:

  • Define ALCOA/CCEA.
  • Apply the skills for completing comprehensive source document templates.
  • Identify inconsistencies with protocols compared with the electronic data capture system instructions to capture all requested data points.

Speaker(s):

  • Jennifer Kennedy, CCRC, Regulatory Affairs Manager, JAEB Center for Health Research

Credits Available


The Evolution of Source Documents Exam

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Kirsten Shuler
6/27/21 6:11 pm

This is an excellent presentation for not only the new study coordinator, but also for those who have been doing it for years. The presenter is engaging and provides examples and there are some good audience questions as well.