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Director’s Update: New and Existing Clinical Datasets Available to Qualified Researchers

NIMH believes that the full value of data from the clinical research it funds is maximized if the data are made broadly available to the wider scientific community, provided the confidentiality and privacy of study participants are protected. Data sharing enables researchers to analyze data beyond the expertise or time constraints of the original study investigators.

In addition to a broad range of available NIMH clinical trials datasets, researchers can now access data from the NIMH-funded Coordinated Anxiety Learning and Management (CALM) study. CALM compared delivery models for treatment of multiple anxiety disorders. The CALM dataset is the most recent dataset among NIMH-funded clinical trials to be made available on the NIMH Limited Access Data web page. The NIMH policy for distributing limited access datasets from NIMH clinical trials describes the responsibilities of investigators seeking access to clinical trial data, what data are provided, and the safeguards for these datasets.

The NIMH Limited Access Data web page also contains data from large-scale NIMH studies, such as the Multimodal Treatment Study of Children with ADHD (MTA), Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), Sequenced Treatment Alternatives to Relieve Depression (STAR*D), the Treatment for Adolescents with Depression Study (TADS) and others, as are data from some smaller trials. NIMH encourages researchers that are interested in mining the available data to submit a request for data access. Researchers seeking access to clinical trials data must submit an appropriate Data Use Certification (DUC), which requires the Federal Wide Assurance number from the researcher’s institution, as well as a signature from the relevant Institutional or Business Official.

Email nimhdatasets@mail.nih.gov to obtain the specific DUC for the dataset of interest. The DUC outlines terms and conditions to ensure the privacy and confidentiality of the study participants are protected.

The requested dataset, which is mailed to qualified researchers on an encrypted CD-ROM, generally includes:

  • The individual data files of trial participants, formatted in the statistical software ASCII and SAS. To protect participant privacy, personal identifiers are not included.
  • Documentation, such as a general description of the study, its components, forms, protocols and procedures, variables, and a list of major study publications.

For any further questions about NIMH Clinical Trials Datasets, please email nimhdatasets@mail.nih.gov.