If you decide to participate in a clinical study, you will be asked to sign an Informed Consent form. This shows that you have been educated to all the aspects of the trial and you are willing to participate in the activities of the trial. All of the risks and benefits and the purpose of the research are provided during the consenting process.
Most studies will require that you have several things completed, a few examples are; a history and physical, blood specimens obtained, heart monitoring (ECG), radiological exams, such as x-ray, CT, and/or MRI. Depending on the design of the protocol, the study specific procedures and tests may be billed to your insurance company as standard of care or be provided by the sponsor.
If it is determined that you are eligible to participate in the clinical study, you will be asked to return to the facility for a series of visits based on the study guidelines.
The clinical trial team includes doctors and nurses as well as other health care professionals. These team members will check your health at the beginning of the trial, give specific instructions for participating in the trial, and monitor you carefully during the trial. Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work closely with the research team. Your participation in the clinical trial is most successful when the protocol is carefully followed and there is frequent contact between yourself and the research team.