2. THE PRINCIPLES OF ICH GCP
2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.
2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
ADDENDUM
This principle applies to all records referenced in this guideline, irrespective of the type of media used.
2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
2.12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.
ADDENDUM
Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems.
Clinical Research News
Upcoming Clinical Trials
-
NCT04710628Not yet recruitingConditions: Metastatic Thymic Carcinoma; Thymoma Type B3
-
NCT04710641Not yet recruitingConditions: Hepatocellular Carcinoma; Hepatitis B; Hepatitis C
-
NCT04710654Not yet recruitingConditions: Functional Constipation
-
NCT04710680Not yet recruitingConditions: Colonoscopy Nonattendance; Inpatient
-
NCT04710719Not yet recruitingPost-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of KeloidsConditions: Keloid; Keloid Scar Following Surgery
-
NCT04710732Not yet recruitingConditions: Venous Thromboembolism
-
NCT04710758Not yet recruitingConditions: Stomach Neoplasms
-
NCT04710784Not yet recruitingConditions: HIV/AIDS; Sexually Transmitted Infections
-
NCT04710797RecruitingConditions: Ovarian Cancer; Lymphadenectomy
-
NCT04710823Not yet recruitingConditions: Serratus Anterior Plane Block; Thoracic Paravertebral Block; Ultrasound; Multiple Traumatic Rib Fractures; Analgesia
Recent CRA jobs
-
Procurement Analyst
-
Clinical Research Associate - Bordeaux
-
Assoc Compliance Spec
-
Cognos Developer
-
Executive Director, Enterprise Strategy - Innovation
-
Assoc Biostatistics Dir (remote or office-based in any US location)
-
(Senior) CRA - Johannesburg OR Durban - 60,000 ZAR JOINING BONUS!
-
Senior Principal – Value & Development Consulting, Evidera
-
Med Technologist - 2nd shift - Generalist
-
Sr Business Systems Analyst