Amy Earl   •   about 10 years ago

Patient Considerations

Patient Considerations (risk/benefit of study participation, study logistics and post study plans) are listed as a required field. However, I do not see these outlined in the sample trial nor in any of the trials on clinicaltrials.gov. Could you please point out where I find a sample of these? Thank you.

• 3 comments
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  Megan Arend Manager   •   about 10 years ago

  Hi aearl,

  Thanks for writing. Yes, "Patient Considerations" is a required section and "Risk/Benefit of study participation", "Study logistics" and "Post study plans" are required fields.

  The content associated with each of these fields can be found in the following documents:

  Sample Study Protocol
  http://challenges.s3.amazonaws.com/eli-lilly/Sample%20Study%20Protocol.pdf

  Sample Study Informed Consent Document http://challenges.s3.amazonaws.com/eli-lilly/Sample%20Study%20Informed%20Consent%20Document.pdf

  Sample Study ClinicalTrials.gov page http://www.clinicaltrials.gov/ct2/show/NCT00789373

  Please be sure to read through each of the documents carefully to find the relevant information, as it's not all listed in one place.

  Best,
  Megan

• 

  Sergey Voronov   •   about 10 years ago

  there are no info on post study plans and logistics in any materials provided (

  risks/benefits can be found in informed consent though

• 

  Megan Arend Manager   •   about 10 years ago

  Hi SergeyV,

  Thanks for writing. Please read through this Definitions Document, which explains the meaning of each section and field, and tells you the type of content that belongs in each: http://challenges.s3.amazonaws.com/eli-lilly/Clinical%20Trial%20Visualization%20Redesign%20Definitions.pdf.

  Based on those definitions, you'll note that information on Post Study Plans and Study Logistics can be found in the Informed Consent Document: http://challenges.s3.amazonaws.com/eli-lilly/Sample%20Study%20Informed%20Consent%20Document.pdf.

  Thanks,
  Megan

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