Beginner CRA

CRA BASICS, TIPS AND CAREER DEVELOPMENT FOR ENTRY LEVEL CLINICAL RESEARCH ASSOCIATES OR THOSE INTERESTED IN BECOMING CLINICAL RESEARCH ASSOCIATES

What goes into an ICF?

Informed Consent So what does the ICF need to tell the subject? This is outlined by the Declaration of Helsinki. This document states that in any research conducted on human beings the subject must be informed of the following:

  • Goals of the study
  • Methods to be used
  • Sources of funding
  • Any possible conflicts of interest of the researcher
  • Anticipated benefits 
  • Any known potential risks of the study
  • Any discomfort participation my cause.  

In addition to these study specific details the subject should be informed that their participation in the study is voluntary and they do have the right to withdraw consent to participate at any time without reprimand. The subject should then be given enough time to review the information within the informed consent. The informed consent should be written in easy to read language usually no more than an 8th grade reading level.  I hope this helps. Next time we will discuss how to monitor an ICF. -Sara

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This entry was posted on October 8, 2013 by in Clinical Research Associate, Entry Level CRA Jobs and tagged , , , .
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