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written SOPs are necessary and required for virtually every functional aspect of a clinical trial.

4.9 Efficiency of Developing and Updating Materials

      The ICH is not a regulatory agency or authority. It is however supported by regulatory authorities and regulatory authorities who were instrumental in establishing it as the organization which is looked to for investigative medicinal product standards. Industry trade organizations were partners in driving the establishment of the ICH. The members of those trade organizations committed scientific expertise and monetary support for the ICH so that the standards necessary to harmonize pharmaceutical drug development standards could be put in place. Those standards must then be translated into usable expectations which can be enforced as the must do or at a minimum held as the should do steps for pharmaceutical medicinal product development.

      The ICH as a free standing nonaffiliated standard setting organization is in a position where it can develop a standard in an expedited manner compared to a regulatory authority. In particular the ICH, while its governance does include representatives from the regulatory authorities, does not need to go through lengthy and sometimes politically influenced reviews and challenges when developing a standard. The ICH follows a standard review process that reaches out to all parties, even the general public, but it is a process that is controlled and does not languish due to policy or political upheaval. The final work product must then be accepted and/or adopted by the regulatory authority but experience has already demonstrated that the regulatory authorities have found mechanisms to classify and categorize the ICH standards in a manner which lends relevance without having to translate them into law. The US FDA’s approach of translating ICH guidelines into Good Guidance Practices is an example.

4.10 Value Added Practices and Principles are Adopted

The development of the and other standards by the ICH has moved the needle, so to speak, for furthering ethical and scientific best practices in the conduct of clinical trials throughout the world. A primary example is the country of Japan. When the ICH was founded circa 1990, Japan did not require that informed consent be given to trial subjects. This was a cultural matter however it did impact the usability/acceptability of clinical trial results by the regulatory authorities of other countries and regions because subjects had not been given informed consent. As an original founder of the ICH organization, Japan eventually fully adopted the ethical principle of informed consent. This adoption of the ethical principles inherent in the ICH E6(R2) is probably as important an outcome as any associated with the promulgation of the Standard.

4.11 Summary

      In this chapter you have learned that the ICH E6(R2) Guideline/Standard contributes more than just a list of must or should do expectations as a sponsor, investigator, or IRB plays out their role in the clinical trial endeavor. The Standard serves a policy document where needed; it is more than just the combination of its parts in that it lays out the best practices for functional expectations in terms of how to: design a trial; conduct a trial; record the details of a trial and how to report trial activities in a way that data integrity is maintained. The Standard also serves as a benchmark for ethical expectations for a trial thereby building into the process a moral obligation that would be missing from most standards. The ICH E6(R2) standard is not in and of itself a law but it comes as close to being that as any standard applicable to the clinical trial process. It is really a unique and one of a kind Standard.

      Knowledge Check Questions

      1 The 13 principles found in the ICH E6(R2) were copied from the US FDA’s regulations governing the conduct of investigation new drug studies found at 21 CFR 312. True ___ False ____

      2 Would the maintenance of subject medical history and records confidentiality be categorized as a record keeping function or a trial conduct function? ____________

      3 Review the ICH E6(R2) Standard and prepare a list of 15 sections where the term procedures is listed. Can you find the same requirement/expectation in the regulations from a regulatory authority?

      4 The author states that the ICH is a respected organization. Briefly describe several reasons why you believe the ICH is respected and its Standards seen as authoritative

      5 The ICH E6(R2) Guideline calls for the clinical trial investigator to ensure that informed consent is given to each subject. Do you think that requirement was universal when the Standard was issued circa 1996? Do you know which benchmark ethical publication/policy document first called for informed consent of human subjects?

Reference

      1 1 World Health Organization (2005). Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. World Health Organization https://apps.who.int/iris/handle/10665/43392 (accessed 13 February 2020).

5 Regulatory Affairs

       P. Michael Dubinsky

      GCP Key Point

       GCP is grounded in the regulatory requirements of the participating members of the ICH. Understanding the regulatory lay of the land is therefore essential.

      

5.1 Introduction

      The good clinical practice guidelines, which are the blueprint for this entire text, are a work product of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH, which was initiated circa 1990 by the US FDA, EC/EMA and Japan’s MHLW along with corresponding pharmaceutical industry associations sought to pursue the harmonization of requirements leading to drug registration or approval. Their harmonization effort has led to the removal of unnecessary and often redundant requirements. The ICH has now evolved from a joint commitment of three government organizational units and three industry associations to a legal nonprofit international association under Swiss law. Understanding the ICH organization, its mission and roles is useful. However we suggest you visit the ICH Webpage [1] for insight into all of its history and accomplishments. The webpage is quite complete, easy to navigate, and transparent.

      Since governmental requirements are the underlying foundation of ICH E6(R2) the there is merit in outlining some key points about the regulatory processes, leading to a successful drug registration or approval. The drug development process calls on a wide range of disciplines and while each may not appear to be a direct player in meeting GCP expectations they are all connected.

A key player or set of players in the drug development process will be from the sponsor’s regulatory affairs group. Understanding their roles and responsibilities as they relate to clinical development is useful.

      

5.2 Objectives of the Chapter

      1 To describe in general terms the roles and responsibilities of a regulatory affairs organizational unit and their role in meeting GCP expectations.

      2 To reflect on the nature and purpose of interactions with competent authorities and the links that such interactions have to GCP.

      3 To outline the important and sometimes challenging aspects of communicating with competent authorities during drug development.

      4 To identify key times when meetings with competent authorities play an important role in the communications process about the development scheme.

      5 To outline the general scheme of submissions associated with drug development activities and where they intersect with GCP.

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