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Thread: Subject Identification Code

  1. #1
    Forum Member
    Join Date
    Nov 2011

    Subject Identification Code

    Dear All,

    I’m wondering if most sponsors now still use both “subject initials” and “subject number” to identify patients. Are there any issues/concern from EC of subject confidentiality by using subject initials?

    Your suggestion would be helpful.

    Thank you very much.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    RQA (formally BARQA) GCP webpages has an intersting Q&As on this and Dates of Birth on CRFs and this would apply to any other information collected by the sponsor. :- Ref: RC02 Date: 26th April 2012
    Date of birth and subject initials count as personally identifiable information (PII) which is covered by the European data protection directive (95/46/EC) and local country legislation (e.g. UK data protection act 1988).
    We know the following EU countries have data protection that restricts capture of DOB and subject initials: Germany. Austria, Norway, Finland, Holland, Hungary
    In Germany, initials and date of birth may appear on lab reports which remain on site as source data. Any data going into the EDC and database must be anonymised or pseudonymised. Switzerland also has laws preventing the transfer of any PII outside of Switzerland. In addition, Ethics Committees in certain countries (e.g. Belgium and Spain) request that personal data such as DoB and initials are not collected.
    The EU Data Protection Directive is understood by some companies to mean that collecting subjects’ initials and date of birth on CRF’s could either directly identify subjects, or could identify subjects when this information is combined with other publicly available information. Therefore if the subjects’ initials and DOB are removed the opportunity to identify the patient is reduced.
    On 25th January 2012 the European Commission announced a proposal (see link below) to revise the EU data protection legislation such that it will be in the form of a regulation rather than directive and therefore the inconsistency between EU member states should be eliminated. The new regulation leaves open the question of whether an individual can be identified from a combination of different pieces of information such as initials and date of birth. This is just one of a number of questions that need to be ironed out during the consultation process for the new legislation.

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