gms | German Medical Science

Aim: The author has been the head of the Austrian surveillance sector on behalf of the Austrian Ministry of Health, amongst other duties also responsible for the inspections of clinical trials. After 10 years in this position this presentation tries to summarize the overall impression of the needs and results of the inspections of small clinical trial centers.

Method: Review of overall results, personal impressions and experiences of an inspector

Results: The results concerning quality deriving out of small centers are driven by well known factors like personnel, experience with clinical trials, patient availiability. The quality mainly depends on the personnel and its sobriety. These factors have a greater influence than in large study centers and inclusion of small centers needs bigger efforts from industry to maintain quality. On the other hand less buerocracy, quicker decisions and results may be worth the efforts. It may be worth to establish a broad pre-qualification system within industry to be able to choose these centers more quickly, to be sure about the education standard and to maintain the committment of small centers to be up to date concerning regulatory knowledge, staff and equipment.

Conclusion: Small study centers deliver the same variety of quality as bigger centers as its always the personnel that counts for it. This could be proven by inspection results. The author tries to promote a prequalification system for small centers.