The Impact of the Implementation of the International Conference on Harmonisation Essential Documents on Investigator Sites

Abstract

The Center of Molecular Immunology in Cuba primarily conducts cancer clinical trials. This article assesses the impact of the implementation of the International Conference on Harmonisation's essential documents on investigative sites. Twenty clinical and sponsor investigators were surveyed about the essential documents twice: before and after the essential documents were implemented. Questions covered the following areas of Good Clinical Practice: ethics, quality assurance, documentation, and design and statistics. Respondents rated activities in these areas as strong (Good Clinical Practice was carried out according to standard operating procedures [SOPs]), weak (the activities of Good Clinical Practice were not carried out and investigators did not know the SOPs, ignored them, or were confused about them), or less known (the activities of Good Clinical Practice were carried out but investigators ignored the SOPs or what they referred to). In the first survey, 35.7% of the activities were rated strong and 38% were rated weak; in the second survey, 64% of the activities were rated strong and 16.6% were rated weak. The strongest area of improvement was design and statistics, which showed a 50% improvement.