so we had to find 3 credible articles (I attached them for your review) and for below topic: and write an annotated bibliography.
. Benefit-Risk Assessment topics
Is the use of a structured benefit-risk assessment framework (quantitative, qualitative or quantitative/qualitative) to evaluate an investigational product’s benefits and risks during development providing greater benefits or not?
here were the instructions and requirement for the assignment:
Overview
This assignment requires that you prepare an annotated bibliography with three annotations of peer reviewed publications which provide literature support for your chosen topic for the Business Memo assignment. Each brief evaluative summary is called an annotation or ‘annotated bibliography’. An annotation is a term to describe a brief, evaluative summary which lays out the purpose, main themes, conclusion, credibility of author and source (if this is an article, the source is the journal that published the article), limitations and the critical analysis (does the information in the article add to the existing body of knowledge on the chosen topic).
As important, this assignment requires that you accurately assess what the author(s) is saying in the source document by analyzing and interpreting what the author(s) means without putting a spin on it. Typically, one reads an article two or more times to accurately interpret what the author(s) state.
This assignment is also intended to demonstrate that your ability to conduct research for scholarly source materials, using Himmelfarb Library and websites such as FDA.gov, to find credible works to inform your chosen topic for Assignment 2, the Business Memo.
By completing this assignment, the student demonstrates initial competence in MSHS Clinical Research Program Student Learning Outcome I. Evaluate research design principles through assessment of scientific, medical, regulatory and commercial aspects required to formulate a clinical development plan for an investigational product. This assignment also demonstrates competence in The Joint Task Force Clinical Trial Competency Framework Domain 3.0 Investigational Products Development and Regulation which encompasses knowledge of how investigational products are developed and regulated.
In addition, the student initially fulfills the Program Student Learning Outcome III. Formulate strategies to address ethical and cultural considerations to ensure compliant national and international clinical trial conduct, in relation to key areas such as Good Clinical Practices, subject recruitment/retention, data integrity and risk assessment. which aligns with the Joint Task Force Clinical Trial Competency Framework for Domain 2.0 Ethical and Participant Safety Considerations which encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial.
Resources for Writing an Annotated Bibliography
Click into above Hyperlink to access the Resources for Writing an Annotated Bibliography and Assignment Submission Link.
Note also when using Himmelfarb Library, click on databases/G/Google Scholar. Google Scholar is another searching strategy which is commonly used. The benefit of using Google Scholar within Himmelfarb is that the articles/references will be available next to the citation.
Business Memo Topics and Resources
Listed below is each topic stated with two positions. For this Annotated Bibliography assignment, do not pick a position yet. First complete your Annotated Bibliography. We recommend you let your research guide you in selecting your position. Make an evidence-based selection. You may use any of these resources in your Business Memo. You may not use any of these resources for your Annotated Bibliography assignment and this is what the old writer delivered for annotated bibliography.the feedback I received was:
Thank you for transmitting the three articles used for your AB assignment. I am confirming receipt. Since your topic is focused on the structured BRA, I am thinking that the Ball et al. article may be that helpful since it focuses on safety aspects only.
These three articles are satisfactory for including in your AB assignment. I am not clear if and how the Ball et al. article is going to be supportive of your position.
A student does not have to use all the articles included in the AB assignment for the second assignment.this week’s assignment is the continuation of the annotated bibliographyase on the position we chose which was:
Is the use of a structured benefit-risk assessment framework (quantitative, qualitative or quantitative/qualitative) to evaluate an investigational product’s benefits and risks during development providing greater benefits or not?
we have to : write a Thesis Statement (your position statement) and Introduction for Business Memo. This Discussion Board focuses on your particular thesis statement and Introduction section for the Business Memo assignment. Scenario, that is, to whom and working in what type of organization are you submitting your Business Memo? It is going to be important for you to decide to whom you are writing your Business Memo to, that is, come up with your scenario. It is best to think about this early to help guide you in how you are framing your Business Memo.
Post your draft thesis statement (your position) and the Business Memo information to support your position for this assignment (Pleasepost your main concepts in bullet format as opposed to writing out the whole section in full text).Please try to use a minimum of two (2) articles to support your position, and discussions in your Introduction. Remember search databases, Use GOOGLE Scholar, ; check reference lists of chosen articles etc.
Remember that you are writing a professional business MEMO to an executive. You need to convince your organization’s CEO, COO or President, or vice president/director (whomever!) that your position is the best approach so consider this when you prepare each section of the Business Memo.
Also you can use I. You can use the first person in APA, and APA also prefers using the active voice. In the context of this assignment and the fact that it is a memo, I could absolutely work. As long as the focus is on the research/information/arguments and not placed on you/I.also check the requirements for the business memo to have a better understanding on what to write for the thesis .please note that you need new articles to support your thesis. new credible articles. The attached word document is what I wrote but I believe it is incorrect. Please help me correct this. Technically its supposed to be a thesis on why I believe the benefits are better than the risks in this case and a base for the business memo(attached instruction) for next week.
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