Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Best Practice Guide for Regulatory Affairs in a German CRO - From Application to Clinical Trial Report: Implications of Well-Structured Completion of Relevant Steps ***

Elke Gurschke (Abschlußjahr: 2011)

Clinical trials are relevant parts of the development and for the marketing authorisation of medicinal products, as well as after authorisation, to gain further knowledge about the product. As of 4 April 2001, the basic principles for the conduct of clinical trials were implemented through Directive 2001/20/EC of the European Parliament and of the Council, the so-called "Clinical Trials Directive". Through a profound risk assessment of the results of preclinical investigations and previously conducted clinical trials by the Ethics Committees and the relevant competent authorities of the respective Member State, it should be guaranteed that the safety and well-being of the trial participants, and the preservation of their very own data will be protected in every respect.

Directive 2001/20/EC had been transferred into German law in August 2004 with the 12th amendment of the German Drug Law. Since then, a clinical trial must not be conducted without having received a positive opinion of the responsible Ethics Committee and an approval of the competent authority.

Neither the European directives nor the local implementations in Germany, GCP Ordinance and German Drug Law, give detailed information about the format and quantity of the documents that have to be submitted, and even in large pharmaceutical companies, especially if situated in foreign countries, there is sometimes only poor knowledge about the regulatory requirements of the application process and as well during the conduct of a clinical trial in Germany.

Particulars to the application process, required documents, and the timelines may be obtained through the websites of the relevant parties, e.g. either PEI or BfArM for the competent authorities in Germany, the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices for the local authorities, and the EC Working Group, or their own websites, respectively, for the Ethics Committees. Additionally, guidance documents, e.g. of the European Community, may serve as road signs for what will be needed, but reality differs quite a lot, especially when dealing with Ethics Committees (ECs). Despite any recommendations, e.g. from the EC Working Group, each EC seems to have its own way to deal with the submissions.

A “Best Practice Guide” as provided in this master thesis may help to find a way through the regulatory jungle from the application procedure to the clinical trial report in one single document - at least when conducting a monocentre trial in North Rhine-Westphalia, Germany. Not only relevant documents are presented and their preparation is discussed, but also timelines, formal requirements, and possible snares regarding the submission package are highlighted.

Templates and drafts are of great help to facilitate recurring steps within the process of application for an authorisation of a clinical trial - a variety of what is possible is shown, and as well other measures to well-structured preparation of important documents and timely adherence to relevant timelines are specified.

Pages: 126
Annexes 1-15: Pages: 61