A clinical study report is prepared after a clinical trial is completed. Long before the trial is completed, documents have been prepared which describe what will happen in the clinical trial (protocol), how the data from a clinical trial will be analyzed (statistical analysis protocol) and what participants in the clinical trial have to agree to (informed consent).
Assignment 7:
Prepare a
protocol for an anti-malaria drug, an extract of neem tree for a phase
1 study. You can include this in your protocol and you can prepare it
collectively. Start with a protocol template from the National Cancer
Institute. What you need to find out: what is neem tree, what it is
used for (malaria), what is a phase 1 study (go to NLM at NIH). This
exercise involves searching with Google, and reading the documents
below. The protocol does not have to be very long but needs to include
the elements that you see in the NCI template, and in the protocols
listed below. What are the elements? Why are they important?
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