The guiding document that outlines the framework for a clinical trial, detailing all activities involved, is known as the Study Protocol. This comprehensive document specifies the research's purpose, inclusion criteria for volunteers, activity schedules, methods and treatments, dosages, study duration, and reporting procedures. Equally significant is the Investigator's Brochure (IB), provided by the Sponsor to researchers/investigators, encompassing pharmacology data and accumulated pre-clinical and clinical experience, including beneficial effects and adverse events observed in previous studies with the test product.
Before a patient becomes part of a clinical trial, they sign an Informed Consent Form (ICF). Ahead of this decision, patients spend ample time with one of the investigators who elucidates the study details, including the tests, clinic visits, home responsibilities, and potential discomforts or risks. Patients are thoroughly informed about the medication they will receive. The patient is encouraged to ask questions, ensuring a comprehensive understanding of the implications of study participation. This information is also provided in writing through the informed consent form.
During the informed consent process, investigators must:
The informed consent process safeguards participants and spans from the initial inquiry about the study until its conclusion. Conversations between the investigator and potential participant involve answering questions, and vital study details are presented in a clear written document. The informed consent form undergoes review and approval by regulatory authorities and independent ethics committees before distribution to potential participants. Signing the informed consent form is a prerequisite for enrollment in a clinical trial.
Participant confidentiality is rigorously maintained, with only the investigative team having access to personal data. All study-related data will use participant initials.
The investigator, typically a highly experienced medical doctor, possesses scientific knowledge and clinical expertise. These specialists are often trained in clinical trial practice and lead the clinical study at an investigation site. If conducted by a team, the team leader assumes the role of Principal Investigator (PI).
Clinical trial regulations are based on Good Clinical Practice (GCP) Guidelines, offering standards for trial design, management, development, monitoring, auditing, recording, analysis, and reporting. This framework ensures the reliability and accuracy of reported data, protects patient rights and integrity, and upholds the confidentiality of personal data.
The Investigational Medicinal Product (IMP) refers to the pharmaceutical form of a drug substance or placebo tested or used as a reference in a clinical study.
Clinical trial Sponsors, often pharmaceutical companies or governmental agencies, design strategies and provide financial support for research and drug development. If Sponsors lack internal resources, they may outsource clinical trial implementation to Contract Research Organizations (CROs).
Clinical trials occur in various locations, such as hospitals, physician practices, medical clinics, or teaching hospitals, all certified for research activities by competent health authorities.
To conduct a clinical trial in any country, approval from two regulatory authorities is essential: the Health Authority (HA) and the Ethics Committee (EC) in that country. The clinical trial can commence only after obtaining approvals based on the prevailing legislation.
