
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.
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3 comments
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