The project team Clinical Guidelines was set up on the occasion of the GMDS meeting in Bonn in September 1996. Since then three working sessions have taken place (up to May 1997). The directory includes 17 members, several of which, however, are essentially corresponding or informed members. Dr. H. Nowak, Frankfurt, was appointed interim director by the GMDS committee.

The fundamental guidelines which are relevant to clinical research are published by the CPMP (Committee for Proprietary Medicinal Products, EU) and the FDA (Food and Drug Administration, USA), as well as within the framework of the ICH (International Conference on Harmonization; tripartite: EU, USA, Japan). Other sources of clinical guidelines are the Internet, the Drug Information Journal, and the commercial system IDRAC (by IMS HEALTH).

Information on existing guidelines, in part with reference to the complete texts, are saved in a data base which can be accessed via this page. In addition, the data base contains references to the comments made by the project team on the individual guidelines.

As for further work of the project team, it is planned that the ICH guidelines on the agenda for commentary be examined at regular meetings. The results will be made available to the public on this page.

Suggestions and comments on the work of the project team are always welcome. In this case, please address one of the members or the administrator of this page (U. Harnischmacher). If you have access to guidelines not treated here, or if you would like to comment on existing guidelines, please turn to U. Harnischmacher or H. Nowak.

Guidelines and recommendations were collected which could be of significance for the work of biometricians in pharmaceutical research. Among these are guidelines that are of importance in clinical fields of indication as treatment recommendations in the framework of clinical trials.

One or two key words describing the area of application (topic) were allocated to the guidelines. The data base contains the following information for each guideline: author, title, source, date of publication, country, and whether there is an online version of the guideline. Guidelines available online can be downloaded directly. (You may need the free Adobe Acrobat Reader to open guidelines available as PDF-files.) An online reference to the author or other information is given for some guidelines as well.

You can either search for guidelines according to a certain topic (areas of application) or a country, enter a search term (which should appear in the title of the guideline), or combine the two search possibilities. A maximum of 50 guidelines will be listed, starting with the most recent guidelines.

If you would like to have new or changed guidelines incorporated into the data base, please use the Guideline Form. If you would like to write an abstract for a guideline, please use the Abstract Form.

Members of the Project Team

GMDS Please e-mail errors or changes to Urs Harnischmacher 9 September 1998

visits since Nov 21st, 1997