CoRIS Cohort

Proven
Methodology

Our methodology is accredited. Because providing rigorous information is of the utmost importance to us.

In September 2020, we obtained the Certificate of Quality Management System issued by AENOR. This certification attests that the Quality Management System implemented by CoRIS Coordination Unit complies with the ISO 9001:2015 Standard for the activities below: - “Updating the database of the Cohort of CoRIS”. - “Management of data transfer from CoRIS and sample data from BioBank to researchers”.

By implementing this quality management system, we have defined standards and protocols for each individual stage comprising CoRIS database yearly update, and for the transfer of data from CoRIS and sample data from BioBank. We have thus ensured that each phase is conducted in compliance with the ISO 9001:2015 Standard. Click here to download our quality policy.

YEARLY UPDATE
CORIS DATABASE

On a yearly basis, CoRIS participating centres insert the data of patients participating in CoRIS into a database, which is sent to CoRIS Coordination Unit. We conduct a thorough quality control on the information received from each participating centre. Once the data have been analysed, every centre will receive a report indicating which information is to be verified and corrected, if applicable.

The centres will solve any mistakes identified and, subsequently, send their corrected databases back to the Coordination Unit. We then merge all the centres’ databases to create a joint CoRIS database, which will also incorporate information regarding the samples that are available at HIV BioBank. This database is made available to researchers upon request. Besides, the Coordination Unit sends it to the international collaborations in which CoRIS participates.

MANAGEMENT OF DATA TRANSFER
FROM CORIS AND SAMPLE DATA
FROM BIOBANK

Any researcher can request data from CoRIS or data from CoRIS and samples from HIV BioBank to conduct a research project. In order to do so, researchers must fill out and send the relevant application form to CoRIS Coordination Unit, which will provide them with the number assigned to the project. The proposal will be forwarded to CoRIS Assessment Committee for its perusal. Upon receipt of the Committee’s evaluation, we will send it back to the researcher, who will have to reply to us attaching the modified application form, if requested. The researcher must simultaneously request the project approval from the research ethics committee in his/her centre. The resulting favourable report must be sent to the Coordination Unit.

This report and the application will be sent to BioBank for a second assessment, to which the researcher will have to reply appropriately. Once the project has been approved by both committees, the Coordination Unit will provide the researcher with the Agreement for the transfer of data and/or samples, which he/she must return to us duly signed. After receiving the signed document, we will send the researcher a file with the requested data and/or sample identifiers, a document with relevant information for the project to be conducted and a satisfaction survey. From then on, we will contact the researcher every 6 months to find out how the project is progressing.

If you would like more in-depth information about each one of the stages in this process, we tell you all about it in the following video.

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