the SENOMAC trial
the SENOMAC trial monitoring units
The SENOMAC trial is conducted according to Good Clinical Practice guidelines and monitored by Clinical Research Organisations (CROs) in each country. Documents for investigator site files (in English only) are found at the bottom of this page. Data management is performed by the Swedish CRO, namely the Clinical Trials Unit, Karolinska University Hospital, Stockholm:
CTO, Centrum för Kliniska Cancerstudier, Tema Cancer
Hotellet, plan 3
Karolinska Universitetssjukhuset
171 76 Stockholm
Sweden
Phone: +46 8 517 725 84
Fax: +46 8 30 69 89
Besöksadress/Visiting address:
Elite Hotel, Eugeniavägen 6, plan 3.
171 64 Solna
Data managers and monitors: Yvonne Larsén and Katja Wiklund Panaretakis
Denmark: GCP-enheden, Aarhus University: http://www.gcp-enhed.dk/en/aboutthegcpunits/
Germany and Austria: CRO Tanja Kottmann: https://www.cro-kottmann.de/en/
Greece: CRO Support and Solutions (CROS&S): http://cross-ike.gr/
The following documents may be downloaded as part of the investigator's file (prövarpärm):
Subject enrolment and identification log
Delegation list (signature and responsibility list)
Table of Content - Investigator Site File
Instructions to documents in the Investigator Site File