In Europe, both EU and national legislation determines what is acceptable with regards to patient data access, data linkage and consent issues, including domains such as human rights and duty of confidentiality. Therefore, while individual data custodians may have differing requirements related to what approvals are needed before data can be released, studies conducted in Europe must meet all applicable EU and national legislation.
The provisions of the legislation on the protection of individuals with regard to the processing of personal data and on free movement of such data, as laid down in Directive 95/46/EC and Regulation (EC) No 45/2001 of the European Parliament and of the Council, need to be followed in the EU. For interventional research, the Directive 2001/20/EC and the Guidelines for Good Clinical Practice (Commission Directive 2005/28/EC) apply. Directive 2001/20 EC will be repealed on the day of entry into application of the new Clinical Trials Regulation (Regulation (EU) No 536/2014). In addition, marketing authorisation holders (MAHs) and investigators must follow relevant national legislation and guidance of those Member States where the study is being conducted (Directive 2001/83/EC and Directive 95/46/EC).
Article 36 of the Commission Implementing Regulation (EU) No. 520/2012 specifies that for post-authorisation safety studies (PASS) imposed as an obligation, MAHs shall ensure that all study information is handled and stored in a way that ensure the confidentiality of the study records. The GVP Module VIII - Post-authorisation safety studies recommends that these provisions should also be applied to PASS voluntarily initiated, managed or financed by a MAH.
The ISPE Good pharmacoepidemiology practice provides recommendations on the protection of human subjects and refers to the ISPE guidelines on Data Privacy, Medical Record Confidentiality, and Research in the Interest of Public Health. It also recommends that the plans for protecting human subjects should be described in a stand-alone section of the study protocol.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|