ABSTRACT
It is well understood that in order to reliably interpret the results of a clinical trial and to project its results to daily practice, the design of the protocol, the credentialing and quality assurance (QA) procedures used, and the evaluation of the data are of utmost importance. Credentialing and QA procedures must be designed so that they are able to reliably evaluate the ability of institutions to use the technology dictated by the trial. Other reasons for credentialing and QA are to identify aws in trial design and to assess if deviations from the guidelines of the protocol are caused by misinterpretation of the trial prescriptions or by the inability to comply with the required procedures. It is the authors’ strong conviction that clinical trials must be conducted such that participating patients are treated as stated per protocol, within the established tolerance levels, in order for the results to be interpreted meaningfully.
