Health Medical Homework Help

This assignment needs done ASAP; This assignment was done and the information needs to be confirmed and or corrected in the sections. This needs to be corrected.

Please see the instructions below; I have attached the previously completed file that was not done correctly as well as the template that includes all fo the information that needs to be included and the protocol

• Use the attached template and write the efficacy section based on information in the protocol that is also attached.
• The section 23 bullet points should all be followed in order

• Tables need to uinclude table titles

• Because the lager CSR is an internal document you have full access to its contents
• You should be familiar with the first ~ 130 pages
• You’ll find some information needed to complete a section might actually span different parts of the larger CSR
• ie, it may seem like you’ve found all you need, but keep reading—there may be more later on

Misc:

• You’ll need to work with redacted information related to drug name and other critical details
• Improvise and use fictitious place markers where information you need has been redacted
• One suggestion for the redacted test product name is to simply label your drug “Study Drug”
• A suggestion for the “test product active ingredient” is “SDAI”
• Once you decide what content to extract for your CSRS, you’ll also decide the optimal way to move it from the CSR to the CSRS:
  • Some information can be copy/pasted verbatim (this would not be plagiarism because the document is internal)
    • An example might be statistical phrases, technical descriptions of endpoints, etc.
  • In other areas you will need to paraphrase and summarize large blocks of material into smaller versions without losing the context and key takeaway points. There will simply be too much text in the CSR to include it all – you’ll have to paraphrase it
• NOTE: Be sure to note differences between 1) Efficacy & Safety assessments (page 43) and 2) Efficacy & Safety results (pages 85 – 126)
• NOTE: Be sure that you assess **ALL** of the efficacy and safety assessments and results in your CSRS
  • Hint: see the Table of Contents for a helpful listing of each (sections 5 & 6)
  • This is an area many students make errors on – addressing some (but not all) of the outcomes of interest
• For E&S assessments: a bulleted list works best
• For E&S results: a mix of text (description of the results) + Tables works best

Readings:

• Fossati Wood: Chapter 6 (review as needed), Appendix 8-10
• http://www.niche.org.uk/asset/insider-insight/Insider-Clinical-Study-Reports.pdf (Links to an external site.)
• https://bellevuebiomedical.com/wp-content/uploads/2018/02/Writing-Your-First-Clinical-Study-Report.pdf (Links to an external site.)
• https://www.fda.gov/files/drugs/published/Submission-of-Abbreviated-Reports-and-Synopses-in-Support-of-Marketing-Applications..pdf (Links to an external site.)
• Here is a website for Lilly where you can search their library of CSRS if you’d like to see more examples of wording/content:
  • https://www.lilly.com/clinical-research/csr-synopses