A clinical drug trial is a comparative experimental study conducted to evaluate the efficacy and safety of a therapeutic intervention. In this type of research, the researcher controls the conditions of the study and assigns the participants.

A clinical drug trial is any study that meets any of the following conditions:

• Administration of medication not administered in routine practice.
• Comparison of medications, even if they are commonly used.
• Modification of the dose, posology or route of administration of medications used in routine practice.
• Use of medications in the investigational phase that are not yet marketed.
• Administration of medications not authorized for that pathology.

We speak of a low-level intervention clinical trial when ALL of the following conditions are met:

• 1. The investigational medicinal products, excluding placebos, are authorised.
• 2. According to the clinical trial protocol:
• the investigational medicinal products are used in accordance with the terms of the marketing authorisation,
• or  the use of the investigational medicinal products is based on evidence and is supported by published scientific data on the safety and efficacy of these investigational medicinal products in one of the Member States involved.

• 3. The additional diagnostic or monitoring procedures involve an additional risk or burden for the safety of the subjects which is minimal compared to that of usual clinical practice in one of the Member States involved.

Documents to be provided as part of the protocol

• Application for evaluation as aCEIm of reference (external sponsor).
• IDIAPJGol application form.
• Investigator’s manual or technical sheet of the investigational drug.
• Patient information sheet and Informed Consent.
• AIPD (if applicable).
• List of centers and researchers.
• CV of the IPs of each center.
• Suitability of the facilities
  Insurance policy or justification of the level of intervention.
• Economic report.
• Payment of fees or exemption from payment to the CTIS.

Mandatory sections within the protocol

• Clinical Trials and/or REec Registration.
• Pharmacovigilance.
• Procedures and materials used for subject recruitment (if applicable).

Data Protection Impact Assessment (DPIA)