Inquiry - Clinical Research FAC

What is Scientific Research?
A formal and systematic process aimed at producing, advancing knowledge and/or obtaining answers to problems through the use of scientific methods.

What is Clinical Research?
A research in which human beings take part either individually or collectively, in their entirety or in parts, and which involves them directly or indirectly, including by handling their data, information, or biological materials.

Who can participate in a Clinical Research?
Any individual who, taking an informed and voluntary decision, or under the clarification and authorization of his/her legal guardian(s), agrees to be part of the research. Research participants are not paid, with the exception of Phase I clinical trials or bioequivalence studies.

What is the Informed Consent Form?
This is a document in which the free and informed consent of the participant and/or their legal guardian(s) is made explicit, and must contain all the necessary information, in clear and objective language, for easy and fullest understanding of research participants.

What is a Clinical Research Protocol?
This is a set of documents describing the research in its fundamental aspects and the information related to the research participant, to the qualification of the researchers and to all responsible parties.