Eligible Uses for the Data

The purpose of this repository is to support clinical and translational research that is intended for extramural support. This warehouse was developed for research purposes and is available to approved research projects. Most approved studies will not be initially charged a fee. However, larger or more work intensive projects may be required to pay a fee.

Approved activities for the data may be divided into three categories.

I. Activities Preparatory to Research

These queries do not lead to generalizable knowledge, and cannot be used for presentations or publication. They are not considered research and do not require HRRC approval. Their results may be cited in grant proposals and applications. Three types of preparatory activities pertain.

• Feasibility Studies

• Sample Size Estimation

• Characterization of Source Data

Queries for feasibility determine the number and location of patients who meet study criteria. They can be used to estimate the level of effort needed for recruitment. Confirmation of feasibility improves the chances of funding. Queries for sample size estimation can be done where suitable data is available. Data warehouse staff can provide input parameters for sample size estimation from the population to be recruited. Investigators must prepare a written justification and show that HIPAA requirements are met. Only aggregated, de-identified information is provided. Finally, in characterization of source data, de-identified sample data may be provided to assist in determining the format, data type, units of measurement, and data structure of available records.

II. Database Studies

These queries are used to generate descriptive statistics, or to test hypotheses through cohort studies analysis or by regressing on exposures. De-identified records will be provided for your analysis. Proposals must be submitted to CTSC and HRRC but are usually exempted from review by the latter.

III. Recruitment of Patients

The CTSC Data Warehouse will offer this service at a later time. It is not currently available due to resource limitations. When it becomes available, investigators will need to include a waiver of consent and a HIPAA addendum for the recruitment phase along with their HRRC application, in addition to the informed consent and HIPAA authorizations for the actual study protocol.

Please see the next section for information on Application Procedures.