An observational study with drug prospects is a type of research that aims to obtain data on the effectiveness and safety of drugs without modifying patient treatments or inducing prescription.

In this type of study, subjects are followed for a period of time until the outcome variable occurs, and this has not occurred at the time of the start of the study.

IMPORTANT: To confirm that it is an EOm, all the conditions established in the definition of EOm listed in Art.2.1.a) of RD 957/2020 6 (which replicates Art.2.1.k) of RD 1090/2015 must be met. To evaluate whether it is an EOm, consult apartment 2.1. del siguiente documento: 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 drug.
• Patient information sheet and Informed Consent (if applicable).
• Data Protection Impact Assessment (AIPD) (if applicable).
• List of centers and researchers.
• CV of the coordinating PI (if applicable).
• Payment of fees or exemption from payment

Mandatory sections within the protocol

• Document.
• Economic report.
• Commitment to register in the REec.
• Declaration of responsibility for non-commercial study Promoter-IP (if applicable).
• Pharmacovigilance
  Procedures and materials used for the recruitment of subjects (if applicable).

Data Protection Impact Assessment (DPIA)