One of the most difficult situation facing CRA is to work in a place with out instruction or guide line rule especially when you are dealing with many instruments and methodology .Standard operating procedures (SOPs) are detailed instructions described to attain homogeneity when carrying out a specific function 1,2. Basically, the importance of establishing SOPs in a clinical research center lies in:
better preparation when conducting clinical studies, organization of clinical research processes at the research center, training, professionalism, credibility and quality assurance through process standardization and traceability in auditing and inspections3. The Normative Statute addresses the Inspection Guide for Good Clinical Practices (GCPs), which registers some SOPs that will be required during the inspection of the clinical study in the research center. In Risk Factor Modification Center (RFMC) at St Michael hospital Toronto /Canada emphasize on this issue as corner stone in their work. one of my contribution there was writing of SOP operating ECG system
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