What is clinical research?
Clinical Research is a systematic study for new drugs/products in human subjects to determining safety and efficacy of the new drugs/products.
What are Good Clinical Practices?
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
What is a protocol?
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
What is a clinical trial?
A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
What is informed consent?
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented bymeans of a written, signed and dated informed consent form.
What is an interim clinical study report?
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
What is the ICH definition of clinical trial monitoring?
ICH- GCP defines monitoring as the act of overseeing the conduct of a clinical trial, that is, ensuring that the trial is conducted according to protocol, GCP, SOP and regulatory requirements.
What is a clinical study report?
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6)