European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

MICYRN - Maternal Infant Child and Youth Research Network

Existence of an identified contact person for external enquiries Yes Christine Oriel, Network Coordinator; Barb Storey, Director of Operations
Existence of an internal steering committee Yes as a sta ding alone non for profit incorporated organization, MICYRN has a Board that oversees the activities and provide guidance to the Scientific Director and the Director of Operations
Existence of an external advisory steering committee directing the reporting party No however, RareKids-Can has its own Executive committee and External Advisory Board
Existence of a website Yes www.micyrn.ca www.rarekidscan.com
Existence of newsletter Yes for both MICYRN and RareKids-CAN
Existence of internal databases for disease, condition treatment and/or outcome No MICYRN and RareKids_CAN rely on Clinical Trial Navigators based at each institution to identify investigators interested in participating to a particular clinical trial, targeting a disease or a condition. MICYRN provides support to sponsor for site and investigator identification through a service level agreement.
Provisions to ascertain data protection and data security Yes MICYRN has a collaborating agreement with the Data Coordinating Center at the Women and Children Health Research Institute (WCHRI) based at the University of Alberta. WCHRI is the data coordinating centre of all trials supported by RareKids-Can and most trials supported by MICYRN (those that are not Rare Disease trials). WCHRI use a validated instance of REDCap that has been proved to be compliant with Health Canada regulation (https://www.wchri.org/members-and-trainees/research-platforms/redcap/ and https://help.redcap.ualberta.ca/).
Procedures to access the database by third parties No
Access to external databases/registries No
Standardised process to access an external database No