CEIm

Mission, functions and areas of action

The Ethics Committee for Research with medicinal products (CEIm) is an independent body which, in accordance with the corresponding legal provisions, ensures that the rights, safety and wellbeing of clinical trial subjects are protected. The CEIm provides public assurance of that protection by reviewing and approving clinical trial protocols and the methods used to collect and document the informed consent of the subjects and by ensuring the suitability of investigators, facilities and materials.

More specifically, its functions are as follows:

• To assess the methodological, ethical and legal aspects of:
  • Clinical trials with medicines and medical products.
  • Observational studies.
  • Pharmacodynamic and pharmacogenetic studies.
  • Studies evaluating psychological treatments and surgical procedures.
  • Studies involving invasive procedures and the use of health data (medical records and biological samples).
• To evaluate amendments and modifications to projects approved by the CEIm.
• To track and monitor clinical trials with drugs and clinical research with medical products.

CEIm Composition

The composition of the CEIm attached to the HSCSP is as follows:

President

• Rober Belvís Nieto. Physician. Specialist in Neurology.

Vice-President

• Estela Moreno Martínez. Pharmacist. Specialist en Hospital Pharmacy.

Secretary

• Claudia Erika Delgado Espinoza. Physician. Specialist in Clinical Pharmacology.

Members

• Juan Ángel Aibar Durán. Physician. Specialist in Neurosurgery.
• Núria Alberich Margalef. Lawyer and DPD.
• Cristina Arqueros Núñez. Physician. Specialist in Oncology.
• Maria Rosa Ballester Verneda. Pharmacist.
• Ana Carolina Caballero González. Physician. Specialist in Hematology.
• Beatriz Fernández-Montells Rama. Biomedical Engineer.
• Cristina Galisteo Sáez. Philosophy.
• Ignasi Gich Saladich. Physician.
• Iria González Álvarez. User Attention Unit.
• Marta Lestón Vázquez. Primary Care Pharmacist.
• Laura Lozano Polo. Physician. Specialist in Medical Emergencies.
• Laia Matas Pericas. Physician. Specialist in Internal Medicine.
• Indalecio Morán Chorro. Physician. Specialist in Intensive Care Medicine.
• Caridad Pontes García. Physician. Specialist in Clinical Pharmacology.
• Maria Jesús Portella Moll. Psychologist.
• Marta Pujol Benaiges. Patient’s representative. Non sanitary.
• Maria Teresa Ricart Basagaña. Nurse.
• Santiago Sánchez Cabús, Santiago. Physician. Specialist in Digestive Surgery.
• Jordi Torralbas Ortega. Nurse.
• Cristina Trilla Solà. Physician. Specialist in Ginecology and Obstetrics.
• Lucía Vallez Valero. Pharmacist.

Presentation

The CEIm technical secretariat is responsible for assessing methodological, ethical, legal and other information regarding research projects listed in the agenda of CEIC meetings, and also for advising HSCSP and HSCSP-IR researchers on the preparation and presentation of clinical research projects.

Functions

• To receive, register and validate documentation regarding clinical research projects submitted to the CEIm for evaluation.
• To prepare and send calls for meetings, the agenda and copies of the summary of protocols, patient information sheets and informed consent forms to all CEIm members.
• To prepare and present a description of the projects listed in the meeting agenda, the corresponding methodological, ethical and legal analyses and any other relevant information to the CEIm.
• To act as a point of reference in communication with researchers, sponsors, management/medical management and health authorities on all matters related to evaluated research projects and the operations of the CEIm.
• To prepare and sign CEIm reports and communicate decisions to sponsors and researchers.
• To prepare the minutes of meetings and distribute them on schedule to CEIm members.
• To manage documentation on CEIm operations and activities and on evaluated research projects.
• To process agreements regarding clinical trials to be performed in the HSCSP.
• To certify the actions of the CEIm.
• To prepare the annual CEIm report.
• To ensure compliance with Standard Operating Procedures (SOPs).

Staff

Coordinator
Claudia E. Delgado Espinoza

Subcoordinator
Cristina Galisteo Sáez

Secretary
Albert Querol Gómez

Administrative Staff:
Robert Caballero Bartoli
Marisol Mogollón Gil
Alba Monroy Gómez

Initial presentation and requirements:

Contact Marisol Mogollon (ceiminicial@santpau.cat) 93 553 7764.

Presentation of clarifications and modifications:

Contact Robert Caballero (ceimsantpau@santpau.cat) 93 553 7770.

Contract management:

Contact Albert Querol or Alba Monroy (ceimcontratos@santpau.cat) 93 553 7813 / 93 553 7156.

Technical issues:

Contact Dra. Claudia E. Delgado (cdelgadoe@santpau.cat) 93 553 7634 or Cristina Galisteo (cgalisteo@santpau.cat) 93 553 7154.

Any other queries, please contact:

ceimsantpau@santpau.cat

The financial payment corresponding to this agreement, in the established terms, shall be paid to the HSCSP-IR. Please, send the email to facturacio_ir@santpau.cat.