Extra Credit Opportunity Research Project

Extra Credit Opportunity Research Project

Instructions:

Extra Credit Opportunity Research Project

Rather than wait until the end of the semester, teacher and I are offering the following opportunity to earn extra credit. We are aware of the challenges many of you are facing, and know the importance you put on achieving a high grade in your academic endeavors.

As many of you are aware, the FDA released a COVID-19 Guidance Document on 3/17/20 that not only acknowledges the challenges faced by staff, PIs and IRBs but most importantly the participants in our clinical trials. It is not common for the FDA to release a guidance document without first requesting public feedback; however, as we all know these are not normal circumstances.

For an extra 50 points, your assignment is to draft a 2–3-page paper which will describe actions that a site, sponsor, (including the monitoring plan) and IRB, if applicable may take to mitigate risks, and to ensure patient safety in the following real-life scenario.

Background: Focus on a clinical study in which non-cancer participants had blood samples taken with the goal to detect cancer. Once the participant is diagnosed with cancer, they are required to return to the clinic to have additional samples taken before they begin treatment for their cancer. Please consider this is not a treatment study but a diagnostic trial.

Review the guidance document and formulate what restrictions as a sponsor you would implement for the participants, the monitors and the monitoring plan, any restrictions a site may impose to participants, and also include the role of the IRBs, if applicable. And why you are implementing the restrictions.

As you read the Guidance document keep in mind its focus on patient safety in light of  COVID-19, and societal mandates in place, i.e., social distancing and shelter in place.

You do not have to use APA formatting; however, please include a background or introductory paragraph, describe the actions to be taken per role (sponsor, site and IRB, if applicable), and include a closing statement or paragraph.

You will be graded on organization, grammar, and evidence of how well you articulate your understanding of the Guidance and how it impacts clinical trial operations during the COVID-19 pandemic.

The Guidance document is posted here and is also available in previous readings:

• Please read the attached FDA Guidance for COVID-19. (Published 17Mar20, without public input and amended on 27Mar20) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
• Additional information is included: https://sites.veeva.com/blog/going-digital-with-remote-monitoring-key-considerations/

RUBRIC
Excellent Quality 95-100%	Introduction 45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.		Literature Support 91-84  points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.			Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met.
Average Score 50-85%	40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided.		83-76  points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration.			52-49  points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met.
Poor Quality 0-45%	37-1 points The background and/or significance are missing. No search history information is provided.		75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration.			48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met
You Can Also Place the Order at www.collegepaper.us/orders/ordernow or www.crucialessay.com/orders/ordernow Extra Credit Opportunity Research Project

Extra Credit Opportunity Research Project

PLACE THE ORDER WITH US TODAY AND GET A PERFECT SCORE!!!