Klinische Studien • Klinische SOPs

On this website, the current version of CESARs SOPs are located.

Please Note: Each member of the CESAR is responsible to ensure that he/she is referring to the current version of an SOP as maintained on CESAR’s website.

New versions are password-protected. In case, you have forgotten your password, please send an email to office@cesar.or.at.

List of current SOPs:

SOP	SOP title	Version	Date
01	Clinical Investigations in CESAR	02	10 May 2006
02	Evaluation and Selection of a Clinical Trial Proposal for CESAR	03	25 May 2010
03	Preparation and Structure of Trial Protocols	03	25 May 2010
04	Data Collection Forms (Case Report Forms)	02	11 Jan 2007
05	Patient Information and Informed Consent	02	30 June 2006
06	Selecting the Participating Centers	03	26 Feb 2009
07	Data Flow, Monitoring and Archiving	02	20 Nov 2006
08	Reporting of Adverse Events	02	10 May 2006
09	Statistical Design and Analysis	02	15 Feb 2007
10	Study Report and Publication	01	21 June 2001
11	Quality Assurance	01	21 June 2001
12	Validation of Bioanalytical Methods	01	21 June 2001
13	Pharmacokinetic Data Analysis	01	21 June 2001
14	Population Pharmacokinetic Analysis	02	08 Nov 2007
15	Application for a Clinical Trial Authorisation by Competent Authorities and Ethics Committees	01	15 May 2007
16	Notifications to Competent Authorities and Ethics Committees during and at the end of a Clinical Trial	01	08 Nov 2007
17	Monitoring of a Trial under CESAR Responsibility	01	16 July 2007
18	Study Files: Creation, Maintenance and Archiving	01	29 Jan 2008
20	Cooperation with Investigators and External Partners in Clinical Studies Sponsored by CESAR	01	26 Feb 2009

Evaluation and Selection of a Clinical Trial Proposal for CESAR

 SOP02 Version 03

The original SOPs have been published:

Standard Operating Procedures

for Clinical Trials

Version 01, Approval: June 28th, 2001, Implementation June 21st, 2001

published in "ONKOLOGIE" 2003;26(suppl 6), Oktober 2003