All clinical studies protocol write-up are originally written by physicians who are members of MedNutra. Participation in all clinical studies we design must be completely voluntary. Before joining a study, a volunteer will receive an informed consent form, which provides detailed information about the treatment as well as the required visits to the physician and any procedures that may be done during the visits. These study visits are pre-scheduled according to the study protocol, or a written set of rules that guide the conduct of the study.
Study participants have the right to withdraw their consent at any time during the study. During the course of this clinical study, a patient is provided with any new information that may affect his/her decision to continue participation in the study.
Study protocols, informed consent forms, and the progress of the clinical study are reviewed, approved and monitored by the Review Committee (RC) and the physicians conducting the clinical study. The primary goals of the RC is to protect the public, to determine whether the possible benefits of participating in the study outweigh the risks and to ensure that patients are not pressured into participating in clinical studies.
The inclusion and exclusion criteria are based on the medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.