GOOD CLINICAL PRACTICE

Trials at Medical Center Excelsior are conducted under strict adherence to the established principles of good clinical practice. 

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible.

The protection of clinical trial subjects is consistent with the principles set out in the Declaration of Helsinki. This is a statement of ethical principles developed by the World Medical Association.

Patient rights and safety

No patient shall be enrolled in a clinical trial if there is the slightest doubt about his or her safety. The suitability of an individual for a study is determined after a series of thorough examinations, consultations and investigations under the guidance of qualified professionals.

The patient’s indications and health status are monitored regularly throughout the study. All complaints and adverse effects (if any) shall be duly recorded in the medical records and the patient may withdraw from participation in the study at any time if he/she so deems.

Clinical trials are not conducted against the will of the candidates. Volunteers declare their willingness to participate by signing an “Informed Consent” detailing all their legal rights.

Informed consent

This is a written document which ensures that the volunteers have read even the slightest details of the clinical study and that the experts have answered all their questions.

“Informed consent contains:

• General information about the trial (what is the purpose, duration, type of therapy, etc.);
• the trial procedures – at what dosage and frequency the medication is given, how often the control tests are performed, etc;
• the potential benefits and risks of the therapy, including details of how to report and record any adverse reactions.

Volunteers can read the document at home, discuss their participation with their relatives and make the final decision whether or not to participate.

Each person has the right to refuse to participate in a clinical study or to sign the “Informed Consent” and at any subsequent time to terminate that participation.