Project Plan Form

Project Plan Form Assignment number and due Design element Your project plan date Student Name Title # 1 Research Area Mentor’s name and email address Planned start month and year Planned duration of research project (3-month From (mm/yy): Through (mm/yy): minimum). Location  VU or  not-VU, Where:

Assessment of risks for the conduct of the study List potential challenges for the proposed study, and present alternate plans Proposed Project Timeline (include deadline for presentation of completed research project) List the projected dates for:  Literature review update  IRB approval*  Data collection: records review, interviews, etc.  Data Analysis  Write-up, full text-article**  Presentation at research conference** *Note that all projects need IRB review. No exceptions **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). Note some questions may not include all PICOT elements, e.g. descriptive, qualitative studies • 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. • If prospective enrollment is planned, describe the process including recruitment, screening, consent, etc. • If specific subgroups are of interest, describe (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)? • For qualitative studies, describe the major components in the conceptual framework or theoretical model. • For qualitative studies, this section should also focus on the description of the strategies to collect data on the study outcome(s) (e.g. interview, focus group, observation, etc.), including a description of the data collection tool(s) (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/or outcomes be (if cross-sectional)?

(S) Setting • What will the study location, relevant dates (overall years of study), and methods of data collection be? • For qualitative studies, describe settings of the interviews, focus groups, where participant observations will be seen. How will comfort and trust be established between the observer and participants? Study Design • Descriptive (case report/case series, etc.), ecologic, cohort (retrospective/prospective), case-control, cross-sectional, randomized trial, non-randomized experiment. Strengths • Highlight particular strength(s) of any key study # 2 elements above. Limitations • Are measurement issues anticipated (e.g. use of imperfect/surrogate measurements)? How valid and reliable the study measurements are? • 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).* • How will confounders be measured? • Clarify the type of variable for each confounder • For qualitative studies, consider potential variables that could be included in the coding guide. *If there are several variables, discuss the ten most relevant and summarize the others. Analysis • Describe statistical methods to be used, including strategies to control for confounding. • For qualitative studies, this section should also describe the plan for transcription, coding and # 3 analytical strategy – also plans to assure reliability 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 • For qualitative studies, discuss how the findings will be presented, and consider inclusion of a conceptual model.