Glossary
- ADNI - Alzheimer's Disease Neuroimaging Network. See http://www.adni-info.org. A longitudinal study of progression in Mild Cognitive Impairment and Alzheimer's disease.
- Affected(s), Affected Individual(s) - an individual, or a sample from that subject, in whom the diagnosis of interest has been made, or disease under study, has been diagnosed.
- Biosamples - aka biospecimens, including blood, cell lines, DNA, or other biological material from a given subject.
- Biosample Repository - in the context of the PDBP, a collection of DNA samples, immortalized cell lines, blood, plasma, CSF, urine, and other biosamples with accompanying clinical and pedigree data. For the PDBP, most biospecimens will be banked at the NINDS Repository (currently a contract at Coriell, see http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10).
- Biosample Resource Access Committee (BRAC) - Committee established by NINDS to oversee the policies for PDBP DMR biosample access.
- CDE - Clinical Data Element. The NINDS currently has an effort underway to standardize clinical data collected on NINDS funded studies. See http://www.commondataelements.ninds.nih.gov/#page=Default. These standardized clinical or pathological subject data, regardless of provider, will include essential elements in a consistent way that will be searchable by users.
- Clinical Data Element - see CDEs.
- Control - a sample collected from a subject who does not have the diagnosis under study; a "normal", "healthy" or "unaffected" individual or a sample from such an individual.
- Data Access Committee (DAC) - Committee established by NINDS to oversee the policies for PDBP DMR data access.
- Data submitter - Individual(s) who have clinical, imaging, genetic or biochemical biomarker data specific to a cohort or project supported through the NINDS PDBP.
- Data user - Scientist and their institutional official who request access to data within the NINDS PDBP DMR.
- Data Use Certificate - Document signed by the data user and the data user's institution which outlines the policies for PDBP DMR data use and access.
- DbGaP - The database of genotype and phenotype, a National Library of Medicine (NLM) resource database designed to archive and distribute data from genome wide association (GWA) studies exploring the association between specific genes (genotype information) and observable traits (phenotype information). http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gap.
- DHHS - The United States of America Department of Health and Human Services.
- DMR - Data Management Resource. For the PDBP, the Data Management Resource has a broad role in creating web-based forms to allow CDE data entry: curating entered data: managing data request forms: managing data associated with sample availability: managing sample requests: public outreach: other areas of data management and website resources for the PDBP.
- Federal Wide Assurance - a process by which Institutions and other organizations which work with human subjects undergo credentialing for such work under the ethical and legal standards in place under the United States Government. See http://www.hhs.gov/ohrp/assurances/assurances_index.html.
- Global Use Individual Identifier (GUID) - a unique (symbol/digit) code that can uniquely identify an individual within and across datasets. While the PDBP DMR creates a GUID by means of the Investigator entering some Personally identifiable information, this information is not kept by the DMR and is not associated with the GUID other than at the local site.
- Investigator - As also used in common parlance, a researcher who has funding to study a particular scientific question.
- IRB - Institutional Review Board.
- NINDS - National Institute of Neurological Disorders and Stroke
- NINDS Repository - See Biosample Repository.
- Non-Distribution Agreement - an agreement which outlines the terms of data and sample receipt in which the signer, and their institutional official, agree to not distribute data or samples received from the DMR or the NINDS repository to a third party. The DMR or the PDBP Project Officer, generally, will not authorize distribution of samples to investigators who have not signed and submitted such an agreement.
- OHRP - The Office for Human Research Protections (of the US DHHS), http://ohrp.osophs.dhhs.gov.
- OSHA - Occupational Safety and Health Administration (of the United States Department of Labor), http://www.osha.gov.
- PDBP - the NINDS Parkinson's disease Biomarkers program. For an overview of the program, see Notice NOT-NS- 11-020 (http://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-020.html).
- PPMI - Parkinson's Progression Markers Initiative. A longitudinal study of a cohort of individuals with early stage Parkinson's disease, towards the goal of validation of biomarkers. PPMI is funded by the Michael J. Fox Foundation (MJFF), see http://www.ppmi-info.org/.
- Principal Investigator - a scientist, typically PhD or MD level, who conceives of, obtains funding for, publicizes, and manages research projects.
- Requestor - an investigator who requests data from the database (see user)
- Subject - an individual from whom clinical data and a biospecimen sample(s) has been drawn and submitted to the data management resource and the NINDS repository, respectively.
- Submitter - an investigator who submits data to the DMR, or both data to the DMR and biosamples to the repository.
- Withdrawer - an investigator who requests and receives samples and/or data from the repository and/or DMR.