NIMH Common Data Elements

The National Institute of Mental Health (NIMH), in consultation with the Wellcome Trust and other funders of mental health research, has identified a minimal list of data collection instruments that would be ideal for use by all mental health researchers conducting clinical research to facilitate and harmonize mental health data collection. In NOT-MH-20-067 and NOT-MH-23-105 NIMH announced our expectations related to the use of these common data elements.

For research participants aged 18 or over, the following data must be collected and submitted:

  1. Age
  2. Sex at birth
  3. DSM-5 crosscutting assessment (adult)
  4. WHODAS 2.0
  5. PHQ-9
  6. GAD-7

For research participants younger than 18, the following data must be collected and submitted:

  1. Age
  2. Sex at birth
  3. DSM-5 crosscutting assessment
  4. RCADS-25

The expectation to collect these data for each NDA Collection does not preclude the use of other data collection instruments that collect similar data. Additional information can be found at https://www.nimh.nih.gov/funding/managing-your-grant/nimh-data-sharing-for-applicants-and-awardees.

For research participants who are participating in studies that are not examining diagnostic groups or RDoC relevant groups, the DSM-5 crosscutting, the PHQ-9, and the GAD-7 are not expected to be collected for adult populations. For research participants younger than 18, the DSM-5 crosscutting, and the RCADS-25 will not be included.

Notice NOT-MH-23-105 outlines the expectations for NIMH HIV-related research that involves human research participants.

The NDA Collection for such research will include three different data dictionaries to assess HIV status, antiretroviral therapy (ART), and pre-exposure prophylaxis (PrEP). Those data dictionaries are as follows:

  1. dar_cde1 is the data dictionary that should be used to submit HIV, ART, and/or PrEP information if the data is obtained from research participants’ clinical records or medical charts.
  2. dar_cde2 is the data dictionary that should be used to submit HIV, ART, and/or PrEP information if that data is obtained from research participants’ self-reports.
  3. dar_cde3 is the data dictionary that should be used to submit HIV, ART, and/or PrEP information if that data is obtained from biomarkers or other objective measures collected as part of the research.

Select the dictionary or dictionaries most appropriate for your research. If your research does not require all three data dictionaries, just ignore the ones you do not need. There is no need to delete extra data dictionaries from your NDA Collection. You can adjust the Targeted Enrollment column in the Data Expected tab to “0” for those unnecessary data dictionaries. At least one of the three data dictionaries must have a non-zero value.

Any questions about the appropriate HIV relevant data dictionary(ies) to use for your research should be directed to:

Lori A.J. Scott-Sheldon, Ph.D.
Division of AIDS Research
National Institute of Mental Health (NIMH)
Telephone: 301-792-2309
E-mail: lori.scott-sheldon@nih.gov

Adjustments to Initial Common Data Elements

NDA will deposit what we believe to be the correct set of data structures into your NDA Collection when that NDA Collection is established. If you want to alter that initial set of data structures, please submit a ticket to the NDA Help Desk with a justification for the change. Requests not to collect the common data elements should be sent to the Program Officer for the grant award and/or to:

Gregory K. Farber, Ph.D.
Director, Office of Technology Development and Coordination
National Institute of Mental Health
Telephone: 301-435-0778
E-mail: farberg@mail.nih.gov

Further information about these measures, including licensing information and foregin translations, can be found at:

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