News from the GCP Inspectors Working Group

The GCP Inspectors Working Group has published two documents:

1. The revised Work Plan For GCP Inspectors Working Group for 2008 listing the meetings and tasks for the second half of the year 2008:
As an ongoing activity GCP IWP is updating, as needed, the existing GCP Inspection procedures and guidance for GCP inspections, preparing concept and reflection papers (for example on the conduct of laboratory analyses for clinical trials) and finalising necessary guidances. Details can be found here. The GCP IWG is also continuing their support for the routine GCP inspection programme supporting the centralised procedure and further develops inspection processes related to inspections of clinical trials conducted in developing countries and supports the conduct of inspections in those countries. The Group will assist possible future EU member states to develop their GCP Inspection roles. For example, contacts and collaboration with Croatia, Former Yugoslav Republic of Macedonia and Turkey in the field of GCP Inspections will shall be developed. These countries are invited to observe meetings of the GCP Inspectors Working Group.

2. Question and Answer on records of study subject data relating to clinical trials.
The GCP IWG receives many queries relating to the documentation of study subjects' participation in clinical trials.  This Q and A is the first to be published by the GCP IWG on this topic. However the document is a bit lean as only two Q&As are provided.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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