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At MSKCC, the link between study identifier and patient identifying information was irretrievably destroyed before genetic analysis was performed.
Patient consent was not deemed necessary because issues were obtained from a pathology archive and patient identifying information was anonymized and de-identified prior to analysis.
A trusted office (TTP1) receives patient identifying data (IDAT) plus payload data and generates a patient identifier (PID).
According to the Dutch Medical Research Involving Human Subjects Act, there was no need for informed patient consent or approval by ethical committees, as only registries without patient identifying information were used.
Individual consents were not obtained which is the practice for chart review studies in which individual patient identifying information is not required.
The study did not require patient consent or approval by an ethics committee, as no intervention was involved, data were anonymised and no patient identifying information was included.
Similar(22)
Afterwards all patient- identifying information was removed and the files transferred to SPSS for windows, version 18 (Chicago, IL, USA) for analysis.
A data manager (employed on the project) and the PhD fellow will extract data from the study sites and recode patients and locations to unique study codes under which non-patient identifying data are filed in a CRF per patient.
The Institutional Review Board approved the study protocol and waived the need for individual patient consent or ethical approval to collect and analyze data from registries that exclude patient-identifying information.
No patient-identifying information was collected.
No patient-identifying information was shared between UCSF and Myriad Genetics.
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