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Medication Safety in Pregnancy

Where Am I? -> Current Research & Data -> How to Propose or Commission Specific Studies
Direct link to this page: http://www.EUROmediCAT.eu/currentresearchanddata/howtoproposeorcommissionspecificstudies

 

How to Propose or Commission Specific Studies

 

EUROmediCAT aims to encourage the use of its data and networks for pharmacovigilance and medication safety research. Individual data are only available to consortium members, but we can be commissioned to do a study, or engage in a collaborative study.  Any study involving EUROmediCAT data will be registered in the ENCePP e-register, and will follow the ENCePP Code of Conduct for Scientific Independence and Transparency.

 

 

Step 1

Complete the EUROmediCAT Medication Enquiry Form.  This will state the medication of interest, and will allow the central database to be checked to verify whether the exposure of interest has been recorded sufficiently to warrant a study using the central database, or whether another study design is needed (see Data for a description of types of data and study design other than those based on the central database).

 

Step 2

Request that EUROmediCAT produces an outline protocol, or engages in collaborative protocol development.  This request will go to the EUROmediCAT Steering Group and all potentially participating registries/partners for approval.

 

Step 3

Protocol development including design, data sources, timetable.  Depending on the type of medication or outcome of interest, it may be necessary to conduct a feasibility study first, which will include validation of the quality of the medication exposure information available for the medication of interest.

 

Step 4

Costing. Costs will be determined on a project-by-project basis, to include data costs, data management and administration costs, and any other costs (meetings etc).  Funding contracts will be with one co-ordinating partner, who will engage with all other partners.