BTRA 641 University of Maryland University College Product Life Cycle Essay

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Description

1) For this week’s writing assignment, you will be considering the data that comprises an IND submission. Write a one to two-page essay detailing the type of data collected in pre-IND studies and why the FDA believes it is important to collect this data

2) When is a Pre-IND application submitted to the FDA?

3) What are the three types of FDA meetings? How are these meetings arranged?

4) We have discussed the importance of Informed Consent Forms (ICF) and the consent of subjects required as part of ethical research. There are several elements that must be contained within an ICF to ensure that subjects are provided with the requisite amount of information to make an informed decision to participate in clinical research.

This week writing assignment will take a more practical focus: please draft an ICF for a clinical trial.

You may model the study procedures and ICF details based on one of the following:

  • Trial information available at clinicaltrials.gov (select a trial of interest to you); or
  • Trial information extracted from the Rituximab Protocol (<< see hyperlink)
  • The ICF Checklist for FDA Regulated Research may be helpful to you as you develop your ICF. As part of your preparation, please also consider researching ICF examples and templates to guide your thoughts.
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