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 CEIC.
• 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 Medical Neurology

Vice-President

• Estela Moreno Martínez. Farmacèutica. Especialista en Hospital Pharmacology.

Secretary

• Milagros Alonso Martínez. Physician. Specialist in Clinical Pharmacology

Members

• Juan Ángel Aibar Durán. Physician. Specialist in Neurosurgery.
• Núria Alberich Margalef. Lawyer and DPD
• Cristina Arqueros Nuñez. Physician. Specialist in Oncology.
• Maria Rosa Ballester Verneda. Pharmacist.
• Claudia Erika Delgado Espinoza. Physician. Specialist in Clinical Pharmacology.
• Beatriz Fernández-Montells Rama. Biomedical Engineer.
• Ignasi Gich Saladich. Physician.
• Marta Lestón Vázquez. Primary care pharmacist.
• Laia Matas Pericas. Physician. Specialist in Internal Medicine.
• Indalecio Morán Chorro. Physician. Specialist in Intensive Care Medicine
• Silvana Novelli Canales. Physician. Specialist in Haematology.
• Maria Jesús Portella Moll. Psychologist.
• Marta Pujol Benaiges. Patient’s representative. Non sanitary.
• Maria Teresa Ricart Basagaña. Nurse.
• Miguel Alberto Rizzi Bordigoni. Physician. Specialist in Internal Medicine.
• Santiago Sánchez Cabús, Santiago. Physician. Specialist in Digestive Surgery
• Jordi Torralbas Ortega. Nurse.
• Lucía Vallez Valero. Pharmacist.
• Miguel Àngel Viciana Rodríguez. User Attention Unit.

Presentation

The CEIm 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
Milagros Alonso
E-mail: MAlonsoMa@santpau.cat

Administrative Staff:

Robert Caballero
RCaballeroB@santpau.cat

Marisol Mogollón
Mmogollon@santpau.cat

Initial presentation and requirements:

Contact Marisol Mogollon (mmogollon@santpau.cat) 93-553-77-64.

Presentation of clarifications and modifications:

Contact Robert Caballero (rcaballerob@santpau.cat) 93-553-77-70.

Contract management:

Contact the Secretary of the Service Albert Querol (aquerol@santpau.cat) 93-553-78-13.

Technical issues:

Contact Dra. Milagros Alonso (malonsoma@santpau.cat) 93-553-78-11.

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.