HOW DOES THE CHANGE HE DESCRIBES AFFECT THE ROLE AND RESPONSIBILITIES OF THE CLINICAL RESEARCH ASSOCIATES?

HOW DOES THE CHANGE HE DESCRIBES AFFECT THE ROLE AND RESPONSIBILITIES OF THE CLINICAL RESEARCH ASSOCIATES?

The nature of data management for clinical trials has changed radically with the increased use of electronic data collection. Depending on the size and purpose of the trial, data management can either be a dedicated or a shared function.

To prepare for this Discussion, review this week’s Learning Resources, focusing on the changes in the way clinical trial data management requirements have changed as the use of electronic data systems has increased. Review the article by Timothy Pratt, ”Data Management: R.I.P. or Brave New World?” (Applied Clinical Trials).
post a comprehensive response to the following:
What do you think the author meant when he wrote, ”The EDC/eClinical approach shifts the burden of work to predeployment, and from reactive per instance to proactive per project.” In your response, give specific examples.
How does the change he describes affect the role and responsibilities of the Clinical Research Associates?
Article: Pratt, T. (2006). Data management: R.I.P. or brave new world? Applied Clinical Trials, 15(10), 5864. Retrieved from http://proquest.umi.com.ezp.waldenulibrary.org/pqdweb?did=1165751941&sid=1&Fmt=3&clientId=70192&RQT=309&VName=PQD


 

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