CEIC Introduction

CEIC Introduction

The Centro de Oftalmología Barraquer (Barraquer Ophthalmology Centre) is an Institution with a strong grounding in research, a field where clinical studies are also emphasised. Since the establishment of Clínica Barraquer (Barraquer Clinic), to date the number of proposals for clinical trial performance has constantly been increasing.

The Barraquer Opthalmology Centre's Comité Ético de Investigación Clínica, CEIC (Clinical Research Ethics Committee) was established in 1993 to comply with Law 25/1990 of 20 December concerning medicine, which states that all clinical trial projects with medicine and health products must be previously approved by a Clinical Research Ethics Committee, which must be accredited by the competent authority, which in the case of Catalonia is the Department of Health and Social Security of the Generalitat (Regional Government) of Catalonia.

 ROLES

The roles of the Barraquer Ophthalmology Centre's Clinical Research Ethics Committee are the following:

  • To receive, record and respond to all the documentation required to assess Clinical Trials, PASS and other types of research projects, as well as amending on-going studies.
  • To prepare and send announcements and minutes from the Clinical Research Ethics Committee’s meetings.
  • To inform researchers and developers of the Clinical Research Ethics Committee’s decision and provide the committee's corresponding report alongside it.
  • To receive and record the assessment process of notifications related to on-going studies (annual and final reports, AEs, deviations from protocol, etc.).
  • To process the Centre's Conformity for Clinical Trials, PASS and other types of research projects.
  • To manage the archive and database containing the Clinical Trial documentation and PASS conducted in the Barraquer Centre of Ophthalmology according to the current legislation.
  • To ensure that the Standing Operating Procedures (SOPs) developed by the Committee are applied and to promote their periodical review and modification if required.
  • To develop and follow-up on the Clinical Research Ethics Committee’s annual budget.
  • See to arrangements with the health authorities (accreditation processes, audits, preparation of annual reports, etc...).
  • To control the functioning of Clinical Trials, PASS and other types of research projects that are being developed in the Barraquer Ophthalmology Centre.

 

COMPOSITION

The Barraquer Opthalmology Centre's Clinical Research Ethics Committee, both in its work as well as its SOPs complies with Good Clinical Practice (CPMP/CH/135/95) and Spanish Royal Decree 223/2004 and is currently composed as follows:

President: Dr. Rafael I. Barraquer Compte, ophthalmologist.

Vice-president Dr. Josep E. Baños Díaz, clinical pharmacologist

Secretary: David Cerdán Palacios, optometrist

Chairs:

  • Dr. Josep Lamarca Mateu, ophthalmologist
  • Dr. Ralph Michael, researcher in Ophthalmology
  • Mrs. Montserrat Aymerich Fabregat, hospital pharmacist
  • Mr. Josep Oriol Ramon Marset, jurist, lawyerMrs. Esther Pérez Escobar, qualified nurse
  • Mrs. María Paz Carrillo, Department of Patient Care
  • Mrs. Ester Amado Guirado, Primary Care pharmacist

Testimonials

  • Xavier Trias
    "The Centro de Oftalmología Barraquer (Barraquer Ophthalmology Centre) was born [...]
  • Luis Bassat
    "I have great admiration for Professor Barraquer, for his medical talent, his [...]
  • Mario Vargas Llosa
    "One of the great merits of the Barraquer family is that they have always had a [...]
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