Although all data were harmonised based on consented harmonisation rules, the data from the different cohort studies are still not perfectly comparable owing to differences in study design and data collection procedures, and to inconsistencies in definitions of variables.
We then assigned each statement to one of seven mutually exclusive domains (see fig 2) based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E3 19 as well as an assessment of 10 complete response letters included in the study that an investigator not participating in final statement extraction and coding had reviewed.
Certain sectors will continue, however, to be subject to the existing regulation based on total harmonisation.
Based on our harmonisation, a timeline was designed to bring all identified process times in a sequential order and to show which steps are included.
I also join with António Costa in calling on the Commission to put forward proposals based on the principles of mutual recognition of decisions and of minimum harmonisation.
Each statement was further assigned to one of 64 subdomains, again based on the International Conference on Harmonisation E3 and the review of 10 complete response letters.
There is a need to create a European certification system for education and training in radiation protection, based on the development of standards of proficiency for health professionals, as an instrument to guarantee safety procedures to European citizens, through harmonisation of practice through education and training.
The trial was conducted based on the principles of the International Conference on Harmonisation of Good Clinical Practice guidelines and according to the Declaration of Helsinki in its revised version.
The partnership movement should continue to be based on values of local ownership and alignment; however the issues of fragmentation and harmonisation with other development activities are challenging to the smaller scale non-programmatic IHPs.
Our definition of SIs was based on an International Conference on Harmonisation report [ 14].
It is one of the most successful of all the initiatives established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
