Section # 1

Dear Dr.Naida, in the file "inspection.pdf" you can find mandatory information about FDA GCP Inspections of Clinical Investigators.

Section # 2

in the file "rdfguidance.pdf" you can find mandatory information about how to prepare for an GCP inspection .

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Optional information:

Guidance on triggers for inspections of bioequivalence trials (English only) adopted 20/08/2013    
Procedure for coordinating good-clinical-practice inspections requested by the CHMP (English only) adopted 21/02/2008 23/05/2014  
INS-GCP-2 procedure for preparing GCP inspections requested by the EMEA (English only) adopted 20/09/2007    
INS-GCP-3 procedure for conducting GCP inspections requested by the EMEA (English only) adopted 20/09/2007    
Annex I to procedure for conducting GCP inspections requested by the EMEA: Investigator site (English only) adopted 20/09/2007    
Annex II to procedure for conducting GCP inspections requested by the EMEA: Clinical laboratories (English only) adopted 20/09/2007    
Annex III to procedure for conducting good-clinical-practice inspections requested by the European Medicines Agency: Computer systems (English only) adopted 28/11/2007 06/09/2012  
Annex IV to procedure for conducting GCP inspections requested by the EMEA: Sponsor site and/or Contract Research Organisations (CRO) (English only) adopted 20/09/2007    
Annex V to procedure for conducting GCP inspections requested by the EMEA: Phase I units (English only) adopted 23/07/2008    
Annex VI to procedure for conducting GCP inspections requested by the EMEA: File structure and archiving of documents relating to CHMP requested inspections - in member state and at EMEA (English only) adopted 20/09/2007    
Annex VII to procedure for conducting GCP inspections requested by the EMEA: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (English only) adopted 28/05/2008    
INS-GCP-4 procedure for reporting of good-clinical-practice inspections requested by the CHMP (English only) adopted 20/09/2007 30/07/2013  
Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report at sponsor site (English only)   29/07/2013    
Appendix 2 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report at investigator site (English only)   29/07/2013    
Appendix 3 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report at bioequivalence / bioavailability site (English only)   29/07/2013    
Appendix 4 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP integrated inspection report (English only)   29/07/2013    
Principal documents taken into account for the preparation of procedures for GCP inspections requested by the EMEA
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