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Definition
 
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Identified Genomic Data and Samples definition: Identified data and samples are labelled with personal identifiers such as name or identification numbers (e.g., social security or national insurance number). As the samples and associated data are directly traceable back to the subject, it is possible to undertake actions such as sample withdrawal or the return of individual results. The use of identified data and samples allows for clinical monitoring, subject follow-up and the addition of new data. Identified data and samples coding offers privacy protection similar to general healthcare confidentiality in everyday medical practice. Identified data and sample coding are generally not considered appropriate for purposes of clinical trials in drug development. (ICH)
Anonymised Genomic Data and Samples definition: Anonymised data and samples are initially single or double coded but the link between the subjects identifiers and the unique code(s) are subsequently deleted. Once the link has been deleted it is no longer possible to trace the data and samples back to the individual through the coding key(s). Anonymisation is intended to prevent subject re-identification. As anonymised samples and associated data are not traceable back to the subject it is not possible to undertake actions such as sample withdrawal, or the return of individual results. The use of anonymised data and samples does not allow for clinical monitoring, subject follow-up or the addition of new data. The deletion of the coding key(s) linking the data and samples to the subjects identifiers provides additional confidentiality and privacy protection over coded data and samples, as it prevents subject re-identification through the use of the coding key(s) (ICH).
Anonymous Genomic Data and Samples definition: Anonymous data and samples are never labelled with personal identifiers and therefore there is no potential to trace back genomic data and samples to an individual subject. In some instances only limited clinical data is associated with anonymous samples. As anonymous samples and associated data are not traceable back to the subject, it is not possible to undertake actions such as sample withdrawal, or the return of individual results. The use of anonymous data and samples does not allow for clinical monitoring, subject follow-up, or the addition of new data.
Coded Data and Samples definition: Coded data and samples are labelled with at least one unique code and do not carry any personal identifiers.
Single Coded Genomic Data and Samples definition: Single coded data and samples are labelled with a single code and do not carry any personal identifiers. It is possible to trace the data or samples back to the individual with the use of a single coding key. In general, the clinical investigator is responsible for maintaining the coding key. As the samples and associated data are indirectly traceable back to the subject via the coding key, it is possible to undertake actions such as sample withdrawal, or the return of individual results. The use of single coded data and samples allows for clinical monitoring, subject follow-up, or the addition of new data. Single coding is the current standard used in clinical research and offers additional safeguards to the subject identifiers compared to general healthcare confidentiality and privacy protection in everyday medical practice.
Double Coded Genomic Data and Samples definition: Double coded data and samples are initially labelled with a single code and do not carry any personal identifiers. The data and samples are then relabelled with a second code, which is linked to the first code via a second coding key. It is possible to trace the data or samples back to the individual by the use of both coding keys. In general, the clinical investigator is responsible for maintaining the first coding key and does not have access to the second coding key. As the samples and associated data are indirectly traceable back to the subject via the use of both coding keys, it is possible to undertake actions such as sample withdrawal, or the return of individual results. The use of double coded data and samples allows for clinical monitoring, subject follow-up or the addition of new data. The use of the second code provides additional confidentiality and privacy protection for subjects over that of single coded. Access to both coding keys is needed to link any data or samples back to a subject identifier (ICH).