PNT

The Standard Operating Procedures (SOP) OF THE CEIC (Clinical Research Ethics Committee)

The basic objective of the Standard Operating Procedures of the Barraquer Ophthalmology Centre's Clinical Research Ethics Committee is to define the operating regulations of the Committee, including its structure, basic performance principles, roles, etc.

There are nine official procedures:

1. BASIC PRINCIPLES OF THE COMMITTEE'S PERFORMANCE
2. PROCEDURE FOR METHODOLOGICAL ASSESSMENT
3. PROCEDURE FOR ETHICAL ASSESSMENT
4. PROCEDURE FOR TRIAL ECONOMIC AND SAFETY ASPECTS ASSESMENT
5. DECISION MAKING CRITERIA
6. APPOINTMENT OF EXTERNAL CONSULTANTS BY THE CLINICAL RESEARCH ETHICS COMMITTEE
7. COMMUNICATION BETWEEN THE CLINICAL RESEARCH ETHICS COMMITTEE, RESEARCHERS, DEVELOPERS AND OFFICIAL BODIES.
8. DOCUMENT ARCHIVE
9. PROCEDURE MODIFCATION