CCOI Dataset Profile Inclusion Criteria

Clinical observational datasets are reviewed by NLM’s CCOI for potential and continued inclusion and metadata curation using the criteria listed below.

1. Inclusion Criteria
1. Dataset includes clinical data defined as a collection of data related to patient diagnosis, demographics, exposures, laboratory tests, and family relationships.¹
2. Data were reported to be collected and shared consistent with informed consent of the study participants/patients. Real World Data (e.g., medical claims and electronic health records [EHRs]) was provided in accordance with all privacy laws. Dataset supports biomedical research.
3. Datasets are publicly available or available by request from the dataset provider, with clearly defined request procedures and criteria.
4. Datasets are from data sources managed by government agencies and other non-governmental organizations.
5. Dataset passes CCOI technical review, which consists of data that are:
1. Publicly available or accessible through a data use agreement (DUA) that allows data curation for publication of the CCOI dataset profile.
2. Observational
3. Large scale
6. Metadata can be freely and easily accessed.
7. Data providers meet at least one of the following criteria:
1. Provide an access point with link to dataset and documentation about its usage are publicly available.
2. Provides the ability to find and select clinical observational datasets from a broad spectrum of datasets.
3. Has a responsive point of contact listed by the repository manager.
2. Criteria for removal or updates
1. Dataset provider no longer wants dataset to be included in the CCOI.
2. Dataset was determined to be non-compliant with privacy laws or lacked informed consent from patients or study participants.
3. NLM will regularly review datasets for new versions to ensure CCOI dataset profiles are current. The date of release will be denoted for each of the dataset profiles.

NLM is not responsible for the quality of individual datasets.  Any inquiries about the datasets or their contents should be directed to the dataset provider. The inclusion of a dataset in the CCOI does not represent its endorsement.

For information about IRB requirements and ethics approvals, please contact the dataset provider directly.

Last updated Jun 7, 2024