Rules for launching studies

In accordance with the foregoing, a study will be launched as follows:

  1. The UP CTM will provide assistance with the planning and randomization of the study;

  2. The UP CTM will provide assistance with the international registration of the study;

  3. The PI is under obligation to publish the pre-publication protocol, with which the UP CTM will also provide assistance;

  4. The UP CTM will provide assistance with biostatistical monitoring such that the clinical researcher will be able to maintain regular contact with the biostatistician.