How will you identify your subjects?
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?