GCP VERORDNUNG EBOOK DOWNLOAD

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The implementation of the European legislation into national German law is displayed in Attachment 2 Attachment 2. The situation in Germany is special in that there is a task sharing between the federal higher authority and local authorities within federal states.

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The federal higher authority is responsible for approving clinical trials and licensing pharmaceuticals. Attachment 3 Attachment 3 contains further helpful and publicly accessible information sources regarding GCP inspections. Of particular interest for sponsors based in Germany is the ZLG website [ 7 ], which provides a detailed and excellently rehashed overview of national and international regulations as well as links to international and national authorities.

An identical interpretation of GCP laws and guidelines is mandatory. A first step into this direction has been undertaken by formation of the ZLG and their publicly available procedural requirements.

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A guideline on how to interpret these procedural requirements is however essential. Ideally a continuous dialogue between authorities and sponsors regarding the correct interpretation of the regulatory basis of GCP and the resulting steps for improving quality should be established aiming at improving clinical research and patient safety in Germany.

This reflects a response rate of The companies reported a total of inspections 74 inspections in Germany, from other European countries.

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Of note, the survey only included clinical trials performed by the pharmaceutical industry and does not reflect the situation of investigator initiated research, which might be different.

Specifically we asked for the type of inspection, the responsible inspecting authority e.

Literatur ACDM. Cancer clinical trials - methods and practice. Oxford: Oxford Medical Publications, BGBI I , Google Scholar FDA.

Rockville MD, U. Food and Drug Administration, Guidance for Industry: Computerized systems used in clinical trials.

Good clinical practice. Statistical principles for clinical trials. Google Scholar King DA.

Quantifiable alternative to double data entry. Controlled Clinical Trials Adaptive double data entry: a probabilistic tool for choosing which forms to reenter.

Datenmanagement in klinischen Studien

Controlled Clinical Trials , Management of data in clinical trials. New York: Wiley, Google Scholar McFadden E.

Data management and coordination.New York: Wiley, Thrive and compete in your industry as a digital company. This reflects a response rate of Includes desktop, online, and iPhone access.

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