Project Plan Form 2016-2017 PLAN Please share with your mentor as guiding document for your work in PLAN (Sept 2016/March 2017). Section 1 (blue) is due uploaded with the Pathway to PLAN Research Immersion Planning Form. Additional sections will be completed during the PLAN course. The following template will be used to integrate the concepts introduced during the small group sessions, the personalized interactions with the course instructors, the research mentors and the research area directors. This tool provides a practical opportunity to apply what you have learned and will facilitate your transition to your Research Immersion. The template will serve as a cumulative working document with previous information continually updated and improved based on new knowledge and group feedback. The template is divided in sections and specific assignments to facilitate the progressive development of the plan. Although a few projects may not fit the template perfectly, it provides a simple but complete list of elements common to a structured research plan. The final project plan must be completed and presented by the end of the course. It will be used to evaluate your performance during PLAN. Assignment number and due date Design element Your project plan Student Name Title Research Area Mentor’s name and email address Planned start month and year Planned duration of research project (3-month minimum). #1 Location VU or not-VU, Where: Assessment of risks for the conduct of the study List and present alternate plans Proposed Project Timeline (include deadline for presentation of completed research project plan) List the dates for: From (mm/yy): Through (mm/yy): Literature review update Update protocol Data collection Data Analysis Write-up* Presentation* *May not be applicable Introduction and Study question • Describe briefly the scientific background and rationale. • State the specific research question that the study is designed to address (including PICOT elements). • If hypothesis-driven, state main hypothesis. Clinical and Public Health Implications • How will the proposed study advance our knowledge in the field? (P) Population • How will the study population be defined? • Describe the selection (inclusion/exclusion) criteria. (I) Intervention/Exposure (E+) • What will the intervention/exposure be, and how will it be defined and measured? (C) Comparator Intervention/Exposure (E-) • What will the comparison intervention/exposure be, and how will it be defined and measured? (O) Outcome or “Disease” • What will the outcome/disease be, and how will it be defined and measured? • Will the study include a “no-disease or control” comparator group (case-control or cross sectional study)? (T) Timing • What will the time frame for assessing outcomes be (if cohort)? • Describe the strategy for follow-up • What will the time frame for assessing exposures be (if case-control)? • What will the time frame for assessing exposure and outcomes be (if cross-sectional)? (S) Setting • What will the study location, relevant dates (overall years of study), and methods of data collection be? Study Design • Descriptive (case report/case series, etc.), ecologic, cohort (retrospective/prospective), case-control, cross-sectional, randomized trial. Strengths #2 • Highlight particular strength(s) of any key study elements above. Limitations • Are measurement issues anticipated (e.g. use of imperfect/surrogate measurements)? • Generalizability - based on selection criteria (e.g. How will the study population compare to the target population…who you might apply results to?) Other Study Variables (called Covariates) • Describe potential confounders (e.g. variables associated with both exposure and disease). Analysis #3 • Describe statistical methods to be used, including strategies to control for confounding Proposed Tables/graphs • How will results be presented? NOTE: Include no more than 5 tables/figures in total. • E.g. Table 1: Number of participants, key study participant characteristics (demographic, clinical, social, etc.) information on intervention/exposures and potential confounders, frequency of outcomes/disease events • E.g. Table 2: Main associations • E.g. Table 3: Additional analyses