The complete harmonization guidelines can be found in additional file 1: Harmonization guidelines.
More detailed information about particular countries and further explanations about the harmonization procedure can be found in the "Methods" section.
The description of data harmonization process itself can be described in many ways, but the following 5-step harmonization approach [8] was selected in OTN: 1) Understanding the theory of spatial data harmonization - understanding techniques which can be used for converting data between different data structures, while losing as little information as possible.
Phenotype definition and diagnosis harmonization can also be achieved through standardized clinician training, a model adopted, for example, by Finland.
Harmonization (also called 'normalization') can be approached by decomposing the free-text phrase and mapping to unique identifiers in external semantic resources such as ontologies.
If harmonization of immune assays can be achieved, assays can be tested as surrogate endpoints in clinical trials, substantially accelerate the development of immunotherapeutic agents and, in addition, offer a rationale to pre-select groups of patients with high probability to benefit from subsequent immunotherapy.
Thus, agreements on harmonization of regulations and guidelines can be more complicated and difficult to achieve than may seem to be the case.
Understanding the theory of spatial data harmonization - understanding techniques which can be used for converting data between different data structures, while losing as little information as possible.
For the design to be successful, it is essential that as many assays as possible are involved in the method comparison leading to the harmonization target, and that it can be shown that they sufficiently correlate to that target with consistency of performance over the covered measurement range.
More information about Harmonization for Health in Africa can be found at http://www.hha-online.org/hso.org/hso
