Genotyping was performed on de-identified samples without knowledge of any personal identifiers under IRB approval from Yale University, Washington University in St . Louis and Vanderbilt University.
Under a special arrangement for this project, the Department's Center for Health Statistics implemented the required linkages using patient identifiers under state auspices, and delivered a de-identified, linked database to the study team for further preparation and analysis.
Because of the risk of detection of incidental findings not related to the specific medical conditions under investigation, and due to the fact that genome sequences are considered as personal identifiers under the Swedish law, the IRB precluded public dissemination of the raw genomic sequences.
A fifth distinguishable sub-ontology is Identifier rooted under Data.
The NPR-data relevant to the present study include variables for all admissions related to the procedure under observation: Patient identifier (de-identified), procedure code (Nordic Medico-Statistical Committee's Classification of Surgical Procedures (NCSP)) [ 11], dates and times of admission, discharge and procedure, year of birth, sex, and hospital identifier.
The B-PROOF study has been registered with the Netherlands Trial Register http://www.trialregister.nl under identifier NTR 1333 since June 1 , 2008and with ClinicalTrials.gov under identifier NCT00696514 since June 9 , 2008
Mothers were linked to infants identified by an ICD-9 birth code by a unique 'family' identifier, indicating enrolment under the same plan, relationship status of dependent and year of the child's birth.
Identifiers created under this scheme would wrap together identification of a database, a query to return the cited dataset, the version of the database queried for this analysis, and a number of other useful components.
The study protocol was registered on clinicaltrial.gov under identifier NCT01295775.
