A retrospective observational study with drugs is a type of research that aims to obtain data on the use, effectiveness and safety of drugs with past treatments.

In this study, the data are obtained from existing information (clinical histories, health records, etc.). The analysis is carried out from a specific point in time, reviewing information that has already been collected previously.

IMPORTANT: To confirm that it is an EOmi, all the conditions established in the definition of EOmi that appear in Art.2.1.a) of RD 957/2020 6 (which replicates Art.2.1.k) of RD 1090/2015) must be met. To assess whether it is an EOmi, consult section 2.1. of the following document:Memorando_CEIMS.pdf

Documents to be provided as part of the protocol

• Application for evaluation as aCEIm of reference (external sponsor).
• IDIAPJGol application form.
• Technical sheet of the investigational medicinal product.
• Data Protection Impact Assessment (AIPD) (if applicable).
• Payment of fees or exemption from payment.

Mandatory sections within the protocol

• Economic report (does not apply to SIDIAP projects).
• Declaration of responsibility for non-commercial study Promoter-IP (if applicable).
• Pharmacovigilance.

Data Protection Impact Assessment (DPIA)