What is the CEIC of Cantabria?
- CEIC-C : Clinical Research Ethics Committee of Cantabria
- Ethical and methodological evaluation. Cite corresponding legislation.
- Minimum composition and appointment by the Regional Ministry of Health.
What type of studies does the CEIC have to evaluate?
All clinical research projects that include the handling of patients, their clinical data or their biological samples, for example clinical trials, observational studies, biomedical research projects.
Can I submit an article for IRB/IEC assessment?
Generally speaking, an article reflects the work previously carried out in a project, so it should not be the article that is submitted for assessment, but the project. IRB/IEC assessment must take place BEFORE the research project is carried out.
How and when should a study be submitted for IRB/IEC assessment? There are two different cases:
- Clinical trials: the documentation must be sent between the 1st and 5th of each month, 1 copy in electronic format to the Technical Secretariat of the CEIC of Cantabria (see contact details).
- Observational studies and research projects: the documentation can be sent at any time during the month, in electronic format to the Technical Secretariat of the CEIC of Cantabria (see contact details).
What are the requirements? The documentary requirements vary according to the type of study being submitted. There are several possibilities:
- Clinical trials
- Observational Studies/Posta-authorisation (EPA)
- Studies with Medical Devices
- Biomedical Research Projects
Are there models of documents that I can use?
The CEIC of Cantabria does not have models of compulsory documents (except for the model contract), but it does have models of documents that can be used and/or adapted:
- Patient Information Sheet
- Informed Consent
- Commitment of the Principal Investigator and collaborators
- Suitability of the investigator team
- Suitability of the facilities
- Authorisation of the Head of Service
- Conformity of the services involved
- Report on the repercussion on the care burden
- Synopsis of a research project
- Economic report
- THIRD PARTY FORM
What is the Third Party File?
It is a document to collect your personal data in order to comply with the Organic Law on the Protection of Personal Data.
How often does the CEIC of Cantabria meet?
The CEIC of Cantabria meets every Friday except for the first Friday of each month or in the event that it coincides with a public holiday. Meetings are also suspended during the month of August and in the period between 22 December and 7 January.
How long can it take to get approval?
In the case of clinical trials, the period is 45 days until the first opinion (final or request for clarification) is issued, usually a request for clarification opinion. In all other cases, the first response from the IRB/IEC is between 30-45 days, usually a request for clarification opinion.
What can I do if I need a reply urgently or if the deadline has passed and I have not received a reply?
If for any reason the applicant urgently needs a response from the CEIC, he/she can request a certificate of receipt which acts as an acknowledgement that the CEIC of Cantabria has received the project and will proceed with its evaluation. In case of any doubt, please contact the Technical Secretariat of the CEIC of Cantabria (see contact details).
How do I pay the fees of the CEIC of Cantabria?
- Initial and amendment clinical trials: since the entry into force of the new RD1090/2015, no fees are charged.
- EPAs: No fees are charged (except in the case of EPA-SP, fees from the Regional Ministry).
- Research Projects: No fees.
Address: Edificio IDIVAL, 3rd Floor
Avda. Cardenal Herrera Oria s/n v 39011 Santander
Fax: 942 31 55 17
Delivery of documentation:
Blanca del Pozo Fernández
9220.127.116.11 (Ext. HUMV 72980)
Lorena Martín Guerra
918.104.22.168 (Ext. HUMV 75514)
Technical Secretariat of the CEIm of Cantabria: