{"id":8755,"date":"2022-09-12T13:28:39","date_gmt":"2022-09-12T13:28:39","guid":{"rendered":"https:\/\/iris-cc.cat\/assajos-clinics"},"modified":"2025-09-18T09:09:01","modified_gmt":"2025-09-18T09:09:01","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/iris-cc.cat\/en\/clinical-trials","title":{"rendered":"Clinical Trials"},"content":{"rendered":"\t\t
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CLINICAL TRIALS<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Health research is multidisciplinary and multidimensional and can be classified into basic research, clinical research, and public health research. Within clinical and public health research is where clinical trials with medicines or medical devices and observational studies are framed.<\/h4>

The Clinical Trials Unit of the IRIS-CC is the unit that centralises the aspects of evaluation and contractual, economic and administrative management of clinical trials and observational studies in which the Institute and its affiliated centres participate.<\/h4>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Evaluation, Contractual and Economic Management<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Given the strategic, ethical and legal importance, the responsability for the evaluation and management of clinical trials with medicines, medical devices and observational studies falls on the Clinical Trials Unit of the IRIS-CC.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Technical Office<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The technical office is the structure of the Clinical Trials Unit of the IRIS-CC, responsible for evaluating the suitability of external sponsor studies with CEIm of reference different from the IRIS-CC field. Thus, all clinical trials with medicines or post-authorisation observational studies will be registered when our CEIm is not the evaluating body.<\/p>

This office creates the different files (registration and archiving of all documentation) of biomedical research studies carried out within the field of the Institute. Depending on the type of study and promoter, the necessary administrative and contractual procedures are centralised.<\/p>

This unit is also responsible for controlling the execution of the studies and issuing the invoices of the different observational studies or clinical trials of private or commercial promoter.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Rates<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The following documents contemplate both the Clinical Trials Unit and the CEIm:\u200b<\/h6>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Clinical Trials Unit and CEIm's rates<\/a><\/h3>\n
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Rates exemption or reduction form<\/a><\/h3>\n
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Responsibility statement of clinical research without commercial profit<\/a><\/h3>\n
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CERM protocol<\/a><\/h3>\n
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CEIm<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Ethics Committee for Research with Medicines, Health Products and Clinical Interventions (CEIm, from the acronym in Catalan) is an independent body, formed by members with multidisciplinary training. The main purpose of the Committee is to ensure the protection of rights, safety and well-being of the subjects participating in a biomedical research project and that these projects are carried out with guarantees and in compliance with good clinical practices and in accordance with current legislation.<\/p>

CEIms are accredited in accordance with the terms of Royal Decree 1090\/2015, to issue an expert opinion in a clinical study with medicines and clinical research with medical devices. In addition, the functions entrusted to them in their capacity as CEI (Research Ethics Committee, from the acronym in Catalan) must be added.<\/p>

Researchers willing to launch a clinical research project will need a favourable opinion from the CEIm.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Schedule of Meetings<\/b><\/h6>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The CEIm meets, at least, once a month.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Schedule of IRIS-CC CEIm meetings (2024)<\/a><\/h3>\n
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Schedule of IRIS-CC CEIm meetings (2025)<\/a><\/h3>\n
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The CEIm evaluates the methodological, ethical and legal aspects of all research projects that are developed within its field of action that involve patients or health professionals, health data or biological samples from patients.<\/p>

The documentation required by the CEIm is classified according to the type of study, since the legal and regulatory requirements are different.<\/p>

The requirements and the necessary documentation to process the evaluation of the projects are available in the following two sections:<\/p>