EMA advises study sponsors to amend Informed Consent Forms

In February 2021, the European Medicines Agency updated its guidance in the form of questions and answers (Q&As) on Good Clinical Practice (GCP). GCP is a code of international standards concerning several aspects of clinical trials. In particular, it aims to assure that a study’s results are credible and accurate and that the rights and confidentiality of the study subjects are protected.

EMA has now included a new section in its Q&A Guidance (Question 15). The scope of the new section relates to the access of medical records of clinical trial participants by EU GCP inspectors, particularly for inspections requested by the Committee for Medicinal Products for Human Use. EMA emphasizes that the Informed Consent Form (ICF) should include an explicit passage regarding the authorisation for EU inspectors to direct access and review trial participants’ medical records (including applicable electronic systems) and other personal data. The EMA distinguishes between two scenarios as to the lawfulness of the access to such personal data:

• Case a): inspection by EU inspectors of clinical trials conducted within the EU/EEA

For clinical trials conducted within the EU/EEA, EU inspectors have the authority to review trial participants’ medical records and other personal data even if there is no statement in the ICF allowing access to these records and data. The lawfulness of the processing is based on the necessity for the ‘performance of a task carried out in the public interest/public health’, particularly to ensure high standards of quality and safety of medicinal products. Therefore, the lawfulness of such data review is not dependent on the content of the ICFs. However, EMA stipulates that from an ethical point of view it is good practice to inform the patients that EU inspectors may access their medical records.

• Case b): inspection by EU inspectors of clinical trials conducted outside the EU/EEA

In contrast, for clinical trials conducted outside the EU/EEA, explicit consent should be obtained from the trial participants to access their medical records and other personal data by inspectors/experts from regulatory authorities of an EU/EEA Member State. EMA advises the sponsor to ensure that the wording used would not prevent EU/EEA inspectors from having direct access to the medical records and other personal data of the trial participants, taking into consideration the applicable local legislation and policy on data protection and access to medical records.

EMA emphasizes that compliance with the GCP is in a prerequisite for data that is to be used for the assessment of a marketing authorisation.