RELEVANT TERMS

The document that governs the conduct of a clinical trial and establishes all the activities carried out within is known as the Study Protocol. The Protocol provides information on the research purpose, criteria for including volunteers in the study, the schedule of activities, methods and treatments, dosages, the study period and the reporting methods. Another important document is the Investigator's Brochure (IB), made available to researchers/investigators by the Sponsor, which includes pharmacology data and pre-clinical and clinical experience (beneficial effects and adverse events) accumulated in previous studies with that test product.

Before a patient is included in a clinical trial, he/she signs a document called Informed Consent Form (ICF). Prior to the decision to participate in a clinical trial, patients spend more time with one of the investigators who explains what the study is about (what tests will be done, how often the patients will have to come to the clinic, what the patient will have to do at home, what discomforts or risks may occur). Patients will be informed about the medication they will receive. The patient is then encouraged to ask questions to make sure he or she understands all the implications of study participation. The patient also receives this information in a written document, through the informed consent form.

During informed consent process, investigators will need to:

• Provide all important information about the study so that potential participants are able to make an informed decision whether to enrol (or not) or, if they are already enrolled and new information about the study medication occurs, to continue participation.
• Ensure that potential participants understand the possible risks and potential benefits of participating in the study and the alternatives to ongoing research.
• Explain that enrolment in a clinical trial is completely voluntary. Because the agreement to participate in the research is not a contract, participants can leave a research study at any time.

The purpose of the informed consent process is to protect the participants. It begins when a potential participant first requests information about a study and continues throughout until the end of the study. The investigator and potential participant have conversations that include answering the participant's questions regarding the research. All important information about the study should also be provided to the potential participant in a clear and easy-to-understand written document. The informed consent form is reviewed and approved by regulatory authorities, respectively independent ethics committee, before the document is given to potential participants. A person has to sign an informed consent form to be enrolled in a clinical trial.

The confidentiality of study participants’ personal data will be strictly protected, and only the investigation team will have access to such data.

All data referring to the study will use only the initials of the participants.

The investigator (researcher) is a highly experienced and qualified medical doctor. He/she requires scientific knowledge and clinical experience in patient care. Investigators are usually specialists trained in clinical trial practice. The investigator is responsible for conducting the clinical study at an investigation site, and in case the study is performed by a team at that site, the team leader is appointed Principal Investigator (PI).

The legislation governing the conduct of clinical trials is based on a set of recommendations called "Good Clinical Practice - GCP - Guidelines".

The Good Clinical Practice Guidelines are a standard for the clinical trial design, management, development, monitoring, auditing, recording, analysis, and reporting, which guarantees both the reliability and accuracy of the reported data and results, and protection of patients’ rights and integrity as well as the confidentiality of their personal data.

The investigational medicinal product (IMP) is the pharmaceutical form of a drug substance or placebo that is tested or used as a reference in a clinical study.

Clinical trial Sponsors are usually pharmaceutical companies or governmental agencies that perform research and manufacture medicines. These Sponsors design the strategy and ensure financial support to conduct the clinical trials. If the Sponsors do not have adequate internal resources to organize clinical trials, they outsource (contract) the implementation of clinical trials to specialized companies called Contract Research Organizations (CROs).

Clinical trials are conducted in many different locations, such as hospitals, physician practices, medical clinic or teaching hospitals, all certified for research activities by the competent health authorities.

In order to conduct a clinical trial in any country, the approval of two regulatory authorities is needed: the Health Authority (HA) and the Ethics Committee (EC) in the given country. The clinical trial can only start after obtaining the approvals of these authorities based on the legislation in force.