Clinical Trials Approval Procedure
DOCUMENTS - PROCEDURE - PRACTICE FOLLOWED
Trial Protocols
The document that governs the conduct of a clinical trial and defines all the activities that take place within it is known as the Trial Protocol. The Protocol provides information on the research objective, criteria for volunteer participation in the trial, the schedule of activities, methods and treatments, dosages, trial period and reference methods.
Researcher Documents
The Researcher's Document (IB), available to researchers/researchers on behalf of the Sponsor, which contains pharmacological data and preclinical and clinical experience (beneficial effects and adverse reactions) accumulated in previous studies with this trial product.
Consent Form
Before a patient enrols a clinical trial, he signs a document called Consent Form (ICF). Prior to the decision to participate in a clinical trial, patients spend time with one of the researchers explaining what the study is about (what tests will be conducted, how often patients should come to the clinic, what the patient will be doing at home, what discomforts or risks may arise). Patients are also informed about the medication they will receive. The patient is then encouraged to ask questions in order to make sure they understand all the implications of participating in the trial. The patient also receives this information in writing, via the informed consent form.
Purpose of the Informed Consent
The purpose of the informed consent process is to protect participants. It begins when a potential participant first requests information about a trial and runs through to the end of the trial period. The researcher and the potential volunteer engage in conversations that include answers to the participant's questions about the study. All important information about the study should also be provided to the potential participant in a clear and understandable written document. The informed consent form shall be reviewed and approved by the regulatory authorities, respectively, by an independent ethics committee before the document is given to potential participants. An individual must sign an informed consent form to enroll in a clinical trial.
Principal Researcher
The researcher is responsible for conducting the clinical trial at a research centre and if the trial is carried out by a team at this centre the team leader is designated Principal Researcher (PI).
Good Clinical Practices
The legislation governing the conduct of clinical trials is based on a set of recommendations called "Good Clinical Practice - Guidelines". The Good Clinical Practice Guidelines are a standard for the design, management, development, monitoring, control, data acquisition, analysis and reporting of clinical trials, which guarantees both the reliability and accuracy of the reported data and results as well as the protection of patients' rights and integrity, and the protection of their privacy.
Regulatory Authorities
Clinical trials are conducted in different locations, such as hospitals, doctors' offices, medical clinics or teaching hospitals, all accredited for research activities by the relevant public authorities. In order to conduct a clinical trial in any country, the approval of two regulatory authorities is required: the Health Authority (HA) and the Ethics Committee (EC) in that country. The clinical trial can only be initiated once approvals from these authorities have been obtained under the applicable legislation.
Useful Documents
EMA
Research Center Information
EMA
Research Center Information
OrgId: ORG-100042242
Organization Name: General Hospital of Thessaloniki, Papageorgiou
LocationId: LOC-100069747
