2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
OKIDS - Medicines for Children Research Organization Austria |
|
| Existence of an identified contact person for external enquiries | Yes | OKIDS Gmbh Head Office: Director: Prof.Dr. Ruth Ladenstein, MBA, cPM Project Manager: Andrea Mikolasek |
| Existence of an internal steering committee | Yes | OKIDS Project Management: Mag. Sabine Embacher-Aichhorn (Innsbruck) Mag. Gabriele Pfaffenthaler (Graz) Ass. Prof. Dr. Florian Lagler (Salzburg) a.o.Prof.Dr. Christoph Male ( Vienna) |
| Existence of an external advisory steering committee directing the reporting party | Yes | OKIDS advisory board members: 1) Prof. Dr. Reinhold Kerbl / ÖGKJ (Austrian Society of Paediatrics and Adolescent Medicine), 2) Dr. Bärbel Klepp, BMG (Federal Ministry of Health) 3) DI Dr Christa Wirthumer-Hoche, AGES (Austrian Agency for Health and Food Safety) 4) Dr. Jan Oliver Huber & Mag Helga Tieben , Pharmig (Association of the Austrian Pharmaceutical Industry) 5) OKIDS representatives ( Prof. Dr. Ruth Ladenstein Mag. Sabine Embacher-Aichhorn, Ass. Prof. Dr. Florian B. Lagler, a.o.Prof. Dr. Christoph Male, Mag. Gabriele Pfaffenthaler) |
| Existence of a website | Yes | www.okids-net.at |
| Existence of newsletter | No | planning stage 2/anno as of 2015 |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | OKIDS Intranet with specifications of supported trials beginning with teh birthdate of the network (05/2013: total number 21 trials), industry contacts, disease entities at sites |
| Provisions to ascertain data protection and data security | Yes | Within the respective trial specific data bases GCP conform trial management and data mangement is performed ( i.e. pseudonymisation in RDE trial systems , encrypted data transfer only to and from collaborating sites, ..) |
| Procedures to access the database by third parties | No | In the academic setting a formal application process takes place if secondary use of data is requested. Applications are reviewed by IRBs a/o ethics committees |
| Access to external databases/registries | No | OKIDS cooperates with the Austrian Authorities (AGES)to access EUDRACT Trial Data Base to monitor numbers of trials submitted in Austria. For disease entity specific accruals OKISD may receive information on accrual numbers and trials prior to the formal establishment of the OKIDS network |
| Standardised process to access an external database | No | Written requests only if monitoring of frequencies is the focus; resaerch topics need a formal written application and approval by IRB a/o Ethics |