Research Data Management Tools
Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.
This stage includes tasks and activities that occur early in the design & development of a study, such as:
- biostatistics consultations
- informatics consultations
- bioethics consultations
- identifying co-investigators and collaborators
- exploring funding opportunities
Stanford School of Medicine offers a number of data capture platforms to facilitate clinical research, all of which are recommended over the more traditional choices of Excel, Filemaker Pro and Access, since all three fail to satisfy the HIPAA Privacy Rule requirements.
Data security and privacy reviews: These are conducted by the University Privacy Office, UIT Security and the Information Security Office. Projects using high risk data (which includes PHI) must request a data risk assessment by completing the intake process described here.
- STRIDE-DM, the Data Management application development platform of the Stanford Translational Research Integrated Database Environment, was developed by Stanford Research IT (RIT). It supports the design of custom research data capture systems and also offers integration with the STRIDE Clinical Data Warehouse, which contains both current and historic clinical data from both LPCH and SHC. STRIDE-DM research data management systems are all custom-built by RIT application developers in exchange for salary support to cover the time spent building the database. There is an annual maintenance fee.
- REDCap is a self-service system where the researcher defines the database fields either in a spreadsheet or with the help of user-friendly web tools; once the database fields have been finalized, you can start entering data immediately. RIT offers complementary support during the process of defining and refining your database. There is no annual maintenance fee, thanks in part to funding from the Stanford CTSA (Spectrum).
- STRIDE Secure Workbench is a remote desktop platform allowing researchers to analyze sensitive data with 3rd party software in a secure environment.
- Additional commercial products are also available, such as Medrio (frequently used in drug trials).
Stanford Cancer Institute Research Database (SCIRDB) consults on research data management for cancer and disease groups. Patient data can be provided in formats such as:
- A custom web-based display that shows columns of data for the fields identified in the data dictionary.
- A REDCap database that allows researchers to browse and edit entries for each patient.
The SCIRDB infrastructure offers the following technological capabilities to clients.
- Modern database management with entry and access over the Web when necessary with rigorous attention to the quality of the data
- Establishment and maintenance of databases that can be scaled to increase in size seamlessly as they evolve in terms of hardware, algorithms, and needs of particular projects
- Development of tools for rapid prototyping of data forms and relationships among sources of data, including porting data from laboratory instrumentation to integrated central databases
- Provision of access to various secondary databases, including extensive links to publicly available databases