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ICH E6(R2): Good clinical practice [1] is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. [2]
GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines [1] include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.
Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form).
The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories: [11] Q: Quality Guidelines; S: Safety Guidelines; E: Efficacy Guidelines; M: Multidisciplinary Guidelines; ICH guidelines are not binding, and instead implemented by regulatory members through national and regional governance. [12]
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
Section 4.3.4 of the ICH E-6 Good Clinical Practice: Consolidated Guidance reads "Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights."
Good clinical practice 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.