How to Obtain Data?

1. Identify the Objective of the Study
   

   The Research Informatics Core (RIC) supports any study type, including Patient Recruitment for Research, Retrospective Research, Quality Improvement, Clinical Trials, and Education.

2. Identify the Data Domains and Types
   
   Data Domains

   The Research Informatics Core provides a list of available Data Domains and attributes from the Data Lake. Please review the detailed information in the Data Catalog section to verify that the data required for your study is stored in the repository.

   Data Types
   The data types and the objective of the study (Research or Non-Research ) will determine if your study should have an IRB protocol.
   
   PHI Data for Research Projects
   When requesting data containing Protected Health Information (PHI) for a research project, including quality improvement projects designed to develop or contribute to generalizable knowledge, IRB protocol is required. A new study request should be submitted to the UMass Chan IRB.
   
   PHI Data for Non-Research Projects
   When requesting data containing Protected Health Information (PHI) for a non-research project, an IRB determination is required to determine that the proposed activity is not human subjects research. Please see the IRB’s Request for Not Human Subject Research Determination Form for guidance.
   
   IRB documentation
   RIC ensures the security of patient information by controlling and auditing the distribution of data after UMass Chan Institutional Review Board (IRB) documentation is obtained.
   
   All data projects involving the Data Lake must have the appropriate IRB documentation prior to data release.
   
   

   The IRB may choose to engage the Privacy Office or Information Security during its review of a project. The IRB/Privacy Office may contact investigators directly during this phase with questions about the intended use or disclosure of the requested data elements.

   For any questions regarding IRB protocols, please contact the UMass Chan IRB.
   
   De-identified Data Sets
   If a study involves only de-identified data, void of dates, and all other PHI, a de-identified dataset can be requested by submitting a Data Request form. 
   
   
3. Submit a Data Request
   This form provides details of the data extract. Once received, a member of the RIC support team will be assigned to the project. 
   Here is the link to the Project Request Form.
   
   
4. Data Extract Review Session
   The RIC team member assigned to a project will conduct a working session with the investigator to discuss research needs, provide guidance on available resources, and develop the following steps to provide a quote for the services to be approved by the principal investigator. 
   

   Once funding confirmation is received from the department’s financial administrator, RIC will start work on the project.

For research projects that involve data sources not available in the Data Lake, an exception can be obtained to use such sources if any of the following conditions are met:

1. The Research Informatics Core can’t deliver the dataset
2. A large number of variables required for the study cannot be replicated with the data available in the Data Lake.
3. The investigator has the necessary expertise to develop the appropriate data structures that can support the research study.

The exception process may include security, IRB, and privacy reviews as applicable. In such cases, please request a consultation with RIC for guidance throughout the process and assistance initiating necessary reviews.