Good Clinical Practice Guide
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Thread: MHRA produced FAQs for Inspection Process

  1. #1

    MHRA produced FAQs for Inspection Process

    1. Where can I find further information on this subject?

    For information about the MHRA's GCP inspection process, click here.
    Last edited by MHRA Super Moderator; 25th Oct 2011 at 10:43 AM.

  2. #2
    2. What are the requirements for the provision of TMFs for inspection?

    As per Regulation 31A (1) – (4) and Directive 2005/28/EC Articles 16 & 17 the TMF is the basis for the inspection and should be complete and readily available.

    You should ensure that you have identified ALL the trial documentation and its location that comprises the Trial Master File and determined how this will be made readily available to the inspectors. Remember that the TMF may consist of trial relevant documentation held in files of various departments, e.g. pharmacovigilance, data management, statistics, R&D etc.

    Where the sponsor has subcontracted activities, perhaps the TMF management itself to a CRO, then the TMF and/or the files & documentation held by the sponsor as part of their oversight will need to be provided.

    ALL the documentation that comprises the TMF (that is the documentation that allows the inspectors to evaluate the conduct of trial) must be made available for direct access by the inspectors, including any electronic documentation (for example email correspondence). In many inspections, findings have been given as the organisation has failed to comply with this requirement, even when this has been clearly set out prior to the inspection. Any equipment and software etc to access any electronic documentation will need to be provided by the organisation.

    Prior to the inspection, the inspector(s) are happy to discuss how the TMF will be provided. This may be necessary where the organisation of the TMF is complex, for example, parts or all of it is held outside of UK.

    Further information on TMFs can be found in Chapter 10 of the MHRA GCP Guide and in FAQs on this GCP Forum relating to the TMF and archiving.
    Version 1: 21 December 2012

  3. #3
    3. Can inspectors access medical records of patients participating/who have participated in clinical trials of IMP in the UK if the consent form does not explicitly include consent for Regulators to access these records?

    Yes. In summary, inspectors have the power to request the information and it must be provided, notwithstanding lack of, or defective consent of the patient. This is lawful under an exemption in the Data Protection Act 1998, and the inspectors’ powers in the 2012 Human Medicines Regulations also take priority over the common law duty of confidentiality that health professionals owe to their patients.

    Clinical trials of IMP in the UK are regulated by the Clinical Trial Regulations 2004/1031 and its subsequent amendments. Regulation 47 and Schedule 9 to those regulations modify the enforcement provisions of the Human Medicines Regulations 2012 so that they apply to clinical trials.

    Regulation 327 of the 2012 Human Medicines Regulations gives inspectors the right to access all documents relating to a clinical trial of IMP in the UK and this includes the inspection of medical records of trial participants if requested by an inspector. Access to participants medical records is required to assess compliance with the Clinical Trials Regulations (for example, protocol compliance, GCP compliance, recording, handling and storing all clinical information, safety reporting, archiving etc).

    It is incorrect that the Data Protection Act 1998 (‘the DPA') prevents researchers from providing medical records if there is no explicit consent. Although normally such information should not be disclosed without consent, there is an exemption in the DPA which permits disclosure where required by law.

    The DPA requires all data controllers to handle personal data, including sensitive personal data, such as medical records, in line with the eight data protection principles set out in the DPA. Those conducting clinical trials of IMP will be data controllers for the purposes of the DPA, and must therefore comply with the principles.

    Data Protection Principle 1 requires that any processing (which includes disclosure) of sensitive personal data be fair, lawful and satisfy a condition set out in Schedule 3 of the Act. However, only one of the Schedule 3 conditions need be satisfied for disclosure to be lawful under the DPA. The first condition is that the individual has given their explicit consent to the disclosure, but it is not an absolute requirement. For the purposes of good clinical practice inspections the relevant condition is number 7, where the processing is necessary for the exercise of functions conferred on any person by or under an enactment. A function includes a power or a duty, and thus the power of inspectors under regulation 327 to require those inspected to produce documents or information, falls within this condition.
    Version 1: 02 May 2013

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