Study monitoring

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):

Source data list

Monitoring visit log

Subject enrolment and identification log

Delegation list (signature and responsibility list)

Template for CV

Screening log

Table of Content - Investigator Site File

Instructions to documents in the Investigator Site File