Please answer the following questions. The answers should be from the attached power point slides and other documents;
Research Design and Methods
Subject population
How will you identify your subjects? How will you recruit?
Who is eligible? List your inclusion/exclusion criteria.
If conducting a retrospective review of records, what are the dates of inclusion?
If using vulnerable subject groups (under 18 or over 89, prisoners, pregnant women, elderly, low income individuals), provide justification for your selection.
Procedures
Provide a step-by-step account of what participants will be asked to do at each stage of your study.
What study tests/procedures will be performed?
If accessing medical records, will you be accessing paper records, electronic records, or both?
If accessing records, where are the records located, and how will they be accessed?
What tools will you use to collect your data (forms, surveys, etc.)?
Exactly what data/variables will you collect? Provide data collection sheets to support your protocol.
Will you be maintaining a link between study records and patient records (such as a list that links a Study ID Number to a subject's name, MRN, etc)?
Will you have access to personally identifying information about your subjects? Who else will have access to this information?
Risks to subjects/Minimization of Risks
What risks are present for subjects that participate in your study?
How will you minimize these risks?
Include risks such as breach of personally identifying information
Where are study records stored? Are they secured? Who has access to them?
How will you maintain privacy and confidentiality of your subjects and their information?
Attachment:- Research Design.rar