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SAKK Investigators’ Education March 2015
SAKK Investigators’ Education is a two day event, scheduled for March 19 and 26, 2015
Day 1: Thursday, March 19, 2015 at the SAKK CC, Bern
9.00 Coffee / Registration
9.15 Welcome (Peter Durrer, SAKK CC)
9.20 Introduction: GCP - the historical perspective (Geraldine Dal Pra, Clinipace)
9.45 (Inter)national guidelines on clinical trials (ICH E6, E8, E9, VKlin etc.)
 Overview of guidelines and responsibilities (Geraldine Dal Pra, Clinipace)
10.45 Coffee Break
11.00 Workshop on informed consent forms (Geraldine Dal Pra, Clinipace)
12.00 Lunch
13.15 Some thoughts on: (Geraldine Dal Pra, Clinipace)
 How to inform the patient correctly
 Regulatory obligations in Switzerland
15.00 Coffee Break
15.15 Some thoughts on: (Geraldine Dal Pra, Clinipace)
 How to adequately report / assess safety information
 Principles of monitoring and data management
 Principles of quality assurance, auditing and inspections
16.15 End
Day 2: Thursday, March 26, 2015 at the SNF, Bern
9.00 Coffee / Registration
9.15
9.20
9.35
9.45
10.30
10.45
11.10
11.40
Welcome / Introduction (Peter Durrer, SAKK CC)
The SAKK and SAKK CC (Peter Durrer, SAKK CC)
Introduction to the SPOG (Isabelle Lamontagne-Müller, SPOG)
Development and structure of SAKK protocols (Katrin Eckhardt, SAKK CC)
Coffee Break
Approval process for SAKK clinical trials (Peter Durrer, SAKK CC)
Patient motivation for clinical trials (Jürg Bernhard, IBCSG CC)
Statistical and methodological considerations - Part I (Dirk Klingbiel, SAKK CC)
12.15 Lunch
13.15 Statistical and methodological considerations - Part II (Dirk Klingbiel, SAKK CC)
13.45 Workshop «Implementing SAKK protocols» (Peter Durrer, SAKK CC)
14.45 Coffee Break
15.00 Presentation & Discussion (Peter Durrer, SAKK CC)
15.50 Final remarks, frequently asked questions (Peter Durrer, SAKK CC)
16.00 Training certificate / End
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