6/22/2021
Photo by Christian Lue on Unsplash
The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. A recently added question with answer regards the inspection of study participants’ medical records by regulatory authorities in the EU.
Question 15: “Do GCP inspectors from regulatory authorities of an EU/EEA Member State have the authority to inspect trial participants’ medical records and other data, even if there is no statement in the ICF establishing that trial participants consent to the review of their medical records and other personal data by EU inspectors?”
Answer summary: The added question and answer is intended to reinforce to sponsors the importance of adding a statement in informed consent forms (ICF) for all study participants that explicitly gives permission for the EU inspectors to have access to the personal data in the participants’ medical records or other source documents, including electronic systems. This is applicable for any clinical trial that is 1) conducted within the EU or 2) conducted outside the EU but done to support an EMA regulated trial.
For clinical trials conducted within the EU, the EU inspectors have authority to review personal data regardless of if there is a statement in the ICF permitting this, since it is necessary to ensure the quality and safety of medicinal products in the interest of public health. However, it is a GCP best practice to include the statement in the ICF so the study participants are well informed.
For clinical trials conducted outside the EU, explicit consent is needed from the study participant or their legally authorized representative (LAR). It is suggested to seek guidance from the Institutional Review Board (IRB) for the wording to be included so that it is specific enough to allow the needed inspections. This is important so that the marketing authorization application (MAA), the EU’s equivalent to the US Food and Drug Administration (FDA) New Drug Application (NDA), can be supported. Without an inspection, the quality and integrity of the data cannot be established, possibly causing the data to be rejected and thus weakening the MAA.
You may enjoy our blog on “Another Helpful Resource: EMA’s Good Clinical Practice Frequently Asked Questions Page.”
Need GCP training for yourself or your team? Three interactive eLearning solutions support understanding of GCP. Learn more or try the interactive demo with the links below.
GCP Training: ICH E6(R2) HERE.
Comprehensive training for clinical research naïve or perfect for an intense review.
Good Clinical Practice Training (GCP): Refresher HERE
Condensed training for those familiar with GCP, with additional exercises and scenarios to test level of comprehension.
ICH E6(R2) GCP Training for Investigator Site Personnel HERE
Comprehensive training focused on roles and responsibilities for clinical research site personnel.
All three eLearning courses meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Contact us for enterprise discounts at info@clinicalpathwaysresearch.com.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.