Title II - RULES OF PROCEDURE FOR THE CONTROL BODIES
CHAPTER IV - Procedures
34. PROCEDURE FOR COMMUNICATING STUDIES
The provisions of this article only result of application to those studies regulated in article 14.3 of the Code the communication of which is obligatory.
Companies must provide prior notification of the carrying out, financing or sponsoring of the studies mentioned in article 14.3. Such communication shall not be mandatory when any of the following circunstances occur:
- the sponsorship or funding provided by the company does not represent the majority of the financial resources; or
- the company does not have access, prior to, during or after the study, to the identities of the participating Healthcare Professionals, nor has it intervened in the selection beyond defining the participating group in the study protocol; or
- the study involves the remunerated participation of less than 20 Healthcare Professionals practicing in Spain. The subdivision of a study into smaller units when such units share the same focus, objectives and methods is not permitted.
The communication shall be addressed to the Code of Practice Surveillance Unit at least ten working days before the beginning of the study or exceptional access to the identity of the participants for reasons of quality control.
34.3. Information to be Provided
The communication must contain at least the following data:
a) Company reporting the study.
b) Name of the sponsor: company, scientific society, healthcare institution, other.
c) Title of the study.
d) Objective of the study.
e) Methodology being applied.
f) Planned times of execution.
g) Approximate number of Healthcare Professionals participating in the study.
h) Specialty to which the Healthcare Professionals belong.
i) Geographical scope of the study (international, national, regional, local).
j) Planned remuneration of the participating Healthcare Professionals.
k) Other individuals or legal entities involved in the execution or sponsorship of the study (scientific societies, healthcare institutions, third-party service providers, etc.).
l) In the case of exceptional access to the identity of the participants for reasons of quality control, position in the company of the persons with said access.
A procedure will be put in place to present these communications through electronic media that ensure the agility of the process, its efficacy and the confidentiality of data.
The Code of Practice Surveillance Unit must confirm receipt of the communications to the respective companies, it may at the same time also request additional information or corrective measures for compliance with the Code, if necessary. In the latter case, if the company executes the study without meeting the corrective measures, the Unit may initiate the corresponding complaint procedure.
34.4. Person Responsible
Each company will designate through their legal representative one or two persons responsible for communicating studies who will be the intermediary in these matters and who shall be assigned personal passwords for communicating studies via the Internet/electronic mail. This will also be the person who will contact the Code of Practice Surveillance Unit for any clarifications on the reported studies. The Code of Practice Surveillance Unit will maintain a database in which all reports received will be collected. This will be kept strictly confidential. This database must comply with current regulations on the protection of personal data.