ACM Global - Pharma Services, Clinical Trials, Contract Research, Diagnostic Services

Primarily, the conference provided the opportunity to learn more about the MHRA’s landmark “Guidance document on maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples.” While there are other general guidance documents that discuss clinical laboratory standards, such as ISO 15189 and the BARQA Good Clinical Laboratory Practices (GCLP), from my perspective, there is no other single document that addresses GCP regulatory compliance for central clinical laboratories specifically from the perspective of a regulatory authority.

This guidance document explains how MHRA applies relevant GCP regulations to central laboratories performing testing in support of clinical trials. In addition to standardized clinical laboratory practices such as College of American Pathology (CAP) and CLIA requirements, or ISO, and because the long-standing Good Laboratory Practices (GLP) regulations are focused on regulating testing in laboratory animals, this guidance’s description of good clinical laboratory practice expectations and recommendations will be beneficial to central laboratories, as well as to the pharmaceutical and medical device companies who contract them.

The issue of informed consent is just one example of a GCP issue and how it impacts central clinical laboratories. ICH and FDA regulations provide detailed requirements for informed consent – content, process and responsibilities. While obtaining informed consent from all study subjects is an investigator responsibility, the informed consent form (or document) must be reviewed and approved by an IRB/EC, and sponsors by way of their monitoring obligation, are required to ensure that adequate informed consent has been obtained. In practice, the informed consent documents are often initially developed by the sponsor and provided to clinical investigators as a “template” to be customized to their study site and IRB/EC requirements.

The MHRA guidance illustrates how informed consent directly impacts the central clinical laboratory as well. It is the laboratories’ responsibility to ensure testing performed is consistent with the protocol and with the informed consent given by the study subjects. The guidance provides examples of how central labs can exercise their due diligence in this regard, for example, by ensuring that the work instruction (or laboratory specifications document) lists all protocol-required testing but only such testing, and that there be documentation with the sponsor confirming that the informed consent document adequately describes the protocol-required testing. The contractual agreement between the central laboratory and the sponsor would be another mechanism to document compliance with informed consent requirements.

Sponsors and central laboratories must maintain the clinical research balance of science / ethical principles in light of increasingly complex test requirements, and have an obligation to ensure that patients are adequately informed about what tests are being conducted for the current trial and what future testing might be performed on their specimens, particularly if it involves genetic samples. The informed consent requirement also applies in the context of requests for out-of-scope testing, as the guidance also describes.

I highly encourage you to save the MHRA guidance document to your desktop and always keep it there for reference - I am sure you will find it as helpful as we do!

You may also want to check out this presentation from Dr. Jeff Cummings of Paterson Institute for Cancer Research which provides more highlights of the MHRA guidance.

Do you feel other regulatory bodies should adopt the guidelines outlined by the MHRA? I would love to hear your feedback.

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