Insert name of primary investigator here: _______________________

Identification / title of the outbreak: __________________________

Diagnosis: ________________  Confirmed: 1. Yes  2. No: Diagnosis method:_________________________

Date of initial reporting:__________________

Reporting unit: ________________

Location: ________________

Number of cases to date:__________

Background -justification

* Describe the outbreak: Diagnosis, mode of reporting, number of cases and case fatality ratio.

* Describe how the time, place and person information as well as other elements allowed raising hypotheses about the source of infection.

* Spell out the suspected mode(s) of transmission and / or source(s) for the outbreak

Objectives

* Spell out objectives of the analytical investigation. In most cases, it will be about testing a hypothesis regarding suspected mode(s) of transmission and/or source(s) of the outbreak.

Proposed methods

Null hypothesis

* Spell out the null hypothesis that will be tested with this investigation.

Design

* Describe the type of design (e.g., survey, case-control [most adapted if attack rate < 5%], cohort [Most adapted if attack rate > 10%])  in one short bullet.

* If case control, specify if matching is needed and why

Population

* Specify the population in which the investigation will be conducted (State, district, population size). This will define the group from which your cohort particpants or your cases / controls will be recruited

Case definition

* Spell out the case definition that will be used (May differ from the one used at the hypothesis generation stage, could be more specific, including laboratory confirmation).

Case ascertainment

* Explain the strategy to look for cases to the included (in the case of a case control approach)

Recruitment of controls (for case control studies)

* Explain the recruitment strategy for controls and the matching criteria (if applicable).

Data collection

* Explain shortly (1) what data will be collected {major categories: For example: Demographic  characteristics, socio-economic status, exposure to the suspected food, other risk factors} and (2) the data collection methods. Develop the questionnaire after consensus has been reached on this concept paper.

Analysis plan

* Summarize the type of analysis (e.g., descriptive, analytical, stratified, multivariate) that will be carried out. Dummy tables may help. Mention laboratory analysis if part of the investigations.

Sample size

* Briefly mention the sample size and the main assumptions used to calculate it. This should contain enough information for the reader to redo the calculations and double-check the estimate using the same assumptions.

Expected benefit

* Describe the expected outcome: How this investigation will influence prevention and control activities for the problem in question in the area where the project will be conducted.

Appendix 

* Data collection instrument