Research Design (how you will accomplish your goals) Building the story: Approach (not materials and methods)

Approach - instructions Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted. Discuss potential problems, alternative strategies and benchmarks for success anticipated to achieve the aims.

Each Aim Restate Aim and Hypothesis Restate Aim and Hypothesis Introduction: Promise something interesting Introduction: Promise something interesting Justification and feasibility (rationale and POC) Justification and feasibility (rationale and POC) – Review of literature – Preliminary data Research design: what will be done (quality and impact, not endless details on the how, in your hands) Research design: what will be done (quality and impact, not endless details on the how, in your hands) Expected outcome: return on investment Expected outcome: return on investment Potential problems and alternative approaches: (frequently under-appreciated) Potential problems and alternative approaches: (frequently under-appreciated) Timeline Timeline Future directions Future directions

Sequence for each Aim What will you do? What will you do? Why does this need to be done? Why does this need to be done? What might go wrong? Should be unlikely What might go wrong? Should be unlikely Alternative strategies (if hypothesis wrong) Alternative strategies (if hypothesis wrong) What do you expect and why is it important? What do you expect and why is it important? Future directions: where will this lead? Future directions: where will this lead?

What details are needed How many times will something have to be done before you reach statistical significance? How many times will something have to be done before you reach statistical significance? How will you assess statistical significance? How will you assess statistical significance? How many subjects will be needed, how was that number determined? How many subjects will be needed, how was that number determined? What are the controls? What are the controls? Established details can be referenced Established details can be referenced Use preliminary data to reduce the need for some experimental details Use preliminary data to reduce the need for some experimental details