Purpose
The NIDA Data Share web site is an electronic environment that allows data from completed clinical trials to be distributed to investigators and the public in order to promote new research, encourage further analyses, and disseminate information to the community. Secondary analyses produced from data sharing multiply the scientific contribution of the original research. NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products and procedures to improve human health.
(see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).
This website was created in order to make the NIDA Clinical Trial data available to as wide an audience as possible. As studies are completed and their data become available, this web site will be linked to those data. The following information will be posted per protocol:
- Study protocol
- Reference to study publication of primary outcome
- Data sets (SAS and ASCII )
- Annotated case report forms
- Define file (also known as Data Dictionary)
- Study-specific de-identification notes
Protection of Human Subjects
Our primary concern in sharing data is the protection of human subjects. The rights and privacy of people who participate in NIH-sponsored research must be protected at all times. Thus, data on this site have been completely de-identified to prevent linkages to individual research participants. This includes removal of all Personal Health Information (PHI) and indirect identifiers that are not listed as PHI but could lead to “deductive disclosure” such as comment fields and site numbers. Study specific de-identification methods are documented with each protocol.
Data Formats
Data are available in either a Clinical Data Interchange Standards Consortium (CDISC) format or a Case Report Form (CRF) format. For some studies, both formats are available. For the CDISC format, prior to de-identifying the data, all data files are converted from their native format to a modified Study Data Tabulation Model (SDTM) standard format. This facilitates the pooling of shared data across completed studies, as the variable names are consistent across studies. For the CRF format, separate data files are created for each CRF collected in the study. This will make it easier for researchers interested in looking at all data from a single CRF in one data file, as the data files match the CRF exactly.
Data files are available for download in two formats: SAS (transport files or .sas7bdat) and ASCII (CSV files). Documentation regarding the data and corresponding study that generated the data are also available under each completed protocol page. This includes the annotated case report form (CRF); a define.xml file outlining the structure, variables, and contents of each dataset; and SDTM mapping for the CDISC data and de-identification rules.
Disclaimer: The trial data sets available on this NIDA Data Share website are derived from the complete trial database. Analysis data sets such as those utilized to develop publications are not included on this website. Please see the primary manuscript or contact the lead investigator for details.
Registration
Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.