What is GEP ?

The primary aim of Good Experimental Practice (GEP) is to ensure that high-quality trials are conducted. This ensures that results can be used by different registration authorities. GEP is concerned with the management of efficacy evaluation trials and with the conditions under which trials should be planned, conducted, assessed, recorded and interpreted so that their results should be comparable and reliable. GEP relates to various aspects: staff qualifications, use of suitable equipment and facilities, protocols, modes of operation, recording of results. In practice, GEP requires consideration of the following:

  • The criteria to be respected by the organizations responsible for the trials;
  • The modes of operation of these organizations;
  • The internal procedures for verification of the use of GEP.

 (PP 1/181(4) Conduct and reporting of efficacy evaluation trials, including good experimental practice)

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