Good Clinical Practice Guide
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Thread: Patient Confidentiality and Data Protection

  1. #1
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    Patient Confidentiality and Data Protection

    Where can guidance be found in respect to the transfer of patient information from investigator sites to laboratories. Increasingly there is a restirction on transfer of patient initial and date of birth, however the removal of these identifiers increases the risks in sample misidentification. I would like to compile a list of countries and there dat protection requirements.

  2. #2
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    Interesting that the EMA "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples" Feb 2012, does not say that no personally identifiable information should be sent to laboratories but gives details of what to do when such things happen:- "On arrival, or prior to processing, each sample and requisition form should be examined to ensure that its label does not display information which reveals the full identity of the trial subject. If information is recorded on the label which compromises the trial subjectís right to privacy, it should be masked. Care should be taken not to obliterate other information which may be needed to identify the sample during analysis or evaluation. ......It would not be appropriate to permanently delete information on a label if there was no other way of identifying the sample. In such cases the trial subjectís full personal details should be masked and a unique identifier assigned to the sample by the laboratory. ...The sponsor or their representative and/or the investigator should be notified of all instances of inappropriate labelling of clinical trial samples as soon as is practically possible."

    The MHRA GCP Guide (2012) (13.7.3) again says what should be done when subject identifiable information is sent to the lab, not that no such information is expected to be sent:- "The trial subjectsí right to confidentiality must8 always be considered by the laboratory. If samples or associated documentation contain information which identifies a trial subject, measures must8 be taken to ensure the information is masked and not disseminated further. The most common issue that laboratories are likely to encounter is the receipt of samples that detail the trial subjectís name. All laboratories should have documented procedures for dealing with the receipt of such samples which will include procedures for masking the information and informing the investigator site from which the samples originated".

    Section 7.5.3.2 of the MHRA GCP Guide 2012 states that, "laboratory results with subject identifiers" can be sent to Sponsors, provided that subjects explicitly consent to this and that proper data protection measures are in place. If this information can be sent to Sponsors it is logical that it could also be sent to Laboratories (with subjects explicit consent). It is not known if other GCP inspectorates have the same view.

    It would be interesting to know if this is an expectation by all interpretations of EU National Data Protection laws ??

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