For Clinical Trial Investigators

Clinical trials supported by the National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) should employ a core set of common data elements (CDEs) selected from this site when developing case report forms. This will help establish data collection across all new CTN trials that use standardized data to support meaningful data exchange and integration of data to answer research questions of broad interest on substance use.

CDEs on this site include validated standard instruments selected by consensus of experts in the field, measures from the Substance Abuse and Addiction (SAA) project and other components of the Phenotypes and eXposures (PhenX) project sponsored by the National Human Genome Research Institute (NHGRI). Certain data elements have been developed for and widely used on many previous CTN studies.

Only CDEs that meet ISO/IEC 11179 Metadata Registry standards are included. This list is expected to grow as new data elements are developed and validated by external investigators, and as these and other relevant PhenX data elements are curated in the NCI’s cancer Data Standards Repository (caDSR).

The rigorous curation employed in the caDSR ensures that these CDEs have a succinct definition that facilitates meaningful exchange and analysis across multiple studies and longitudinal analyses. It is critical that the CDEs are used in accordance with the definitions and meaning provided in the metadata and that appropriate training is given to ensure compliance with the CDE metadata prior to data collection.

CDEs on this site that are categorized for use in clinical research or for electronic health records (EHRs) may be used on CTN clinical trials. It is hoped that core data elements used in both EHRs and clinical research may in the future support useful comparative analyses that cross the boundary between clinical care and clinical research.