REQUISITES

CEIC REQUISITES

The requisites of the Comité Ético de Investigación Clínica (Clinical Research Ethics Committee) are the documents that either the developer of a clinical trial or the corresponding CRO must present to the Committee, so that it may assess the research protocol and issue its decision.

 

1. PROCESSING

In accordance with the provisions established in Spanish Royal Decree 223/2004, the period to present documentation will be between the 1st and 5th days of each month. Failure to comply with documentation presentation may mean that the study is not accepted for assessment in this session.

 

2. ASSESSMENT APPLICATION

The documents that must be presented to the Clinical Research Ethics Committee are the following:

 Clinical trial assessment application

  • Letter of application for assessment. In the event that the trial has previously been approved in another Centre, then this approval report from said Centre's Clinical Research Ethics Committee will be added
  • A copy (in Spanish) of the proposed clinical trial Protocol, set out following the format required by current valid legislation
  • A copy of the abstract of the Protocol in accordance with current standards
  • A copy of document “Información a proporcionar a los potenciales participantes en el estudio” (Information to be provided to potential participants in the study) and Informed Consent
  • Copy of documentation on the drug, healthcare product or procedure relevant to the assessment of the proposed Protocol
  • Copy of the Researcher's manual
  • Copy of the data collection logbook
  • Copy of the Insurance Policy or proof of financial guarantee for the trial where applicable
  • Compromise document signed by the researchers who are scheduled to take part in the trial
  • Trial proposal. financial report
  • Drafted contract proposed as by the developer
  • Document accrediting payment of the assessment fees or fee exemption application document.

For all intents and purposes, all the documentation related to the functioning of the Clinical Research Ethics Committee will be sent to the attention of the President or Secretary of the Clinical Research Ethics Committee of the Barraquer Ophthalmology Centre.

1 hard copy for the Committee's archives and 1 digital copy of all the documents must be emailed to: ceic@barraquer.com, or a CD must be enclosed.

 

 Application for Post-authorisation study assessment

  • Letter of application for assessment. In the event that the trial has previously been approved in another Centre, then said the approval report from said Centre's Clinical Research Ethics Committee will be added.
  • The AEMPS (Spanish Agency of Medicines and Medical Devices) classification of type EPA (Post-Authorisation Study)(EPA-LA (Post-Approval Commitments), EPA-AS (Simplified Procedure for Approval of Prospective Post-Authorisation Observational Studies), EPA-SP (Procedure for the Approval of Prospective Post-Authorisation Observational Studies with Drugs) or EPA-OD (Procedure for Other Post-Authorisation Observational Studies).
  • A copy (in Spanish) of the proposed clinical trial Protocol, in line with the format required by the current valid legislation.
  • A copy of the abstract of the Protocol in accordance with the current regulation.
  • A copy of document “Información a proporcionar a los potenciales participantes en el estudio” (Information to be provided to potential participants in the study) and Informed Consent form.
  • Copy of the Researcher's manual
  • Copy of the data collection logbook
  • Compromise document signed by the researchers who are scheduled to take part in the trial.
  • Trial proposal. Financial report
  • Drafted contract proposed by the developer
  • Document accrediting payment of the assessment fees or fee exemption application document.

For all intents and purposes, all the documentation related to the functioning of the Committee will be sent to the attention of the President or Secretary of the Clinical Research Ethics Committee of the Barraquer Ophthalmology Centre.

1 hard copy for the Committee's archives and 1 digital copy of all the documents must be emailed to: ceic@barraquer.com, or a CD must be enclosed.

 

Application for assessment of Clinical Trial and Post-Authorisation Study amendments:

  • Developer's letter requesting the assessment of the amendment
  • Copy of the amendment
  • Copy of the document specifying the reason for the amendment, indicating the changes
  • Copy of the final document with the amendment

For all intents and purposes, all the documentation related to the functioning of the Committee will be sent to the attention of the President or Secretary of the Clinical Research Ethics Committee of the Barraquer Ophthalmology Centre.

1 hard copy for the Committee's archives and 1 digital copy of all the documents must be emailed to: ceic@barraquer.com, or a CD must be enclosed.

 

3. ISSUANCE OF OPINION

The Clinical Research Ethics Committee will issue its corresponding decision within the period established by Spanish Royal Decree 223/2004, after the corresponding Committee meeting.

 

4. TO PRESENT THE RESPONSE TO THE COMMITTEE'S CLARIFICATIONS (in the event they are requested):

The response to the Committee's clarifications, if requested, must be presented to the Committee between the 16th and 20th of the month the clarifications are requested or the subsequent month.

 

5. FEES

The Clinical Research Ethics Committee's assessment fees for accepting a Protocol are 500 EUR plus VAT for a unicentric study and 900 EUR plus VAT for a multicentric study.

The Committee's assessment fees for a Relevant Amendment are 350 EUR plus VAT.

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