Scientific Query |
Scientific queries must be based on sound theoretical foundations—the hypothesis (or set of hypotheses) must be testable and precise in construction, makes specific and unambiguous predictions, and clearly defines the research questions that the study will address.
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Exposure-Related |
Actual exposures must be present, as well as a mechanism to characterize and document exposures. Without exposure, or exposure data, the research has a low probability of providing useful public health information.
The proposed research should result in information about an exposure-outcome relationship.
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Study Design |
Critical questions cannot be answered through any other less-costly or simpler way than through a responder research study.
The research has sufficient scientific validity and the ability to answer questions that need to be answered. Confounders can be successfully addressed.
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Feasibility Factors |
Identification and location of subjects and records are possible.
Funding, other resources, and available expertise are sufficient to conduct the study through to its conclusion.
Data-related logistic hurdles, including those related to study size, statistical power, availability of exposure-outcome data, etc., can be overcome.
Regulatory-related clearances can be expeditiously obtained (i.e., OMB approval for federal agencies and Institutional Review Board (IRB) clearance).
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