2. oct.-05 - gvdGCP1 Swiss Agency for Therapeutic Products [ www.swissmedic.ch ] www.swissmedic.ch

3. oct.-05 - gvdGCP2 Inspections of clinical trials in Switzerland A Review [ 2001 – 2005 ] G. Vital-Durand [ gabriel.vital-durand@swissmedic.ch ] gabriel.vital-durand@swissmedic.ch

4. oct.-05 - gvdGCP3 Synopsis Definition Legal and regulatory basis Inspection procedure Demographic data Results Conclusions Why perform inspections ?

5. oct.-05 - gvdGCP4 Some definitions 1.Evaluation préalable1.Preliminary assessment 2.Surveillance pendant l’essai2.Monitoring 3.Contrôle pendant l’essai3.Audit of trial site 4.Inspection pendant l’essai4.Inspection of trial site 5.Contrôle a posteriori5.Delayed audit 6.Inspection a posteriori6.Delayed inspection 1 234 56

6. oct.-05 - gvdGCP5 Why perform inspections ?  GCP Basic principles Protect the subjects or patients

7. oct.-05 - gvdGCP6 Why perform inspections ?  GCP Basic principles Document both the validity and the adequate processing of the data collected Document both the validity and the adequate processing of the data collected 1 Recorded data “Source data” 1 – as per GCP Guidelines

8. oct.-05 - gvdGCP7 « - Quis custodiet ipsos custodes ? » « - Who is to guard the guards themselves ? » Juvenalis, Saturæ (ca. 120 A.D.) Why perform inspections ? 

9. oct.-05 - gvdGCP8 Legal and regulatory basis 1.Loi sur les produits thérapeutiques [LPTh] 1 Heilmittelgesetz [HMG] 2 1 – Art. 54 & 86 [ www.admin.ch/ch/f/rs/812_21/a54.html ]www.admin.ch/ch/f/rs/812_21/a54.html 2 – Art. 54 u. 86 [ www.admin.ch/ch/d/sr/812_21/a54.html ]www.admin.ch/ch/d/sr/812_21/a54.html 2.Ordonnance sur les essais cliniques [Oclin] 3 Verordnung über klinische Versuche mit Heilmittel [VKlin] 4 3 – Art. 27 [ www.admin.ch/ch/f/rs/812_214_2/a27.html ]www.admin.ch/ch/f/rs/812_214_2/a27.html 4 – Art. 27 [ www.admin.ch/ch/d/sr/812_214_2/a27.html ]www.admin.ch/ch/d/sr/812_214_2/a27.html

10. oct.-05 - gvdGCP9 Within the regulatory body At the sponsor site At the CRO site At the site of investigation At the site of ancillary contributions (manufacturer, pharmacy, clinical lab., RX, imaging, etc.) Inspection procedure  At the site of data analysis Patient interviews, etc.

11. oct.-05 - gvdGCP10 Introduction Checking procedures : SOPs, insurance, job descriptions, CT material, etc. Checking CT-related documentation : DE reporting, etc. Wrap-up meeting Inspection report Inspection procedure 

12. oct.-05 - gvdGCP11 Demographic data  Inspections [ 2001 – 2005 ]

13. oct.-05 - gvdGCP12 Demographic data  Clinical Trials [ 2001 – 2005 ]

14. oct.-05 - gvdGCP13 Results 1.Issuing general assessment 2.Whenever required, urgent steps : Suspension, corrections, issuing drug events reports 3. Requesting additional or missing documentation from investigator, sponsor, EC, etc. 4. Drafting report, requesting and reviewing responses 5. Drawing conclusions and offering suggestions for improvements

15. oct.-05 - gvdGCP14 Conclusions 1.Inspections have been conducted actively since 2002 2.Some 5 % of clinical trials with medicinal products are inspected in current year 3. A significant number of the inspections result in disqualifying the site involved, due to “critical findings” 4. On the whole, the standard of clinical trials is improving 5.There is room for expanding the inspection activity, e. g. in ancillary units (manufacturing, pharmacy, imaging, clinical laboratory, biometrics, pharmacovigilance…)

16. oct.-05 - gvdGCP15 Swiss Agency for Therapeutic Products [ www.swissmedic.ch ] www.swissmedic.ch