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

1. How will you identify your subjects? How will you recruit?
2. Who is      eligible? List your inclusion/exclusion criteria.
3. If      conducting a retrospective review of records, what are the dates of      inclusion?
4. If      using vulnerable subject groups (under 18 or over 89, prisoners, pregnant      women, elderly, low income individuals), provide justification for your      selection.

Procedures

1. Provide      a step-by-step account of what participants will be asked to do at each      stage of your study.
2. What      study tests/procedures will be performed?
3. If      accessing medical records, will you be accessing paper records, electronic      records, or both?
4. If      accessing records, where are the records located, and how will they be      accessed?
5. What      tools will you use to collect your data (forms, surveys, etc.)?
6. Exactly      what data/variables will you collect? Provide data collection sheets to      support your protocol.
7. 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)?
8. 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

1. What      risks are present for subjects that participate in your study?
2. How      will you minimize these risks?
3. Include      risks such as breach of personally identifying information
4. Where      are study records stored? Are they secured? Who has access to them?
5. How      will you maintain privacy and confidentiality of your subjects and their      information?