ICH-GCPDIFFERENT SECTIONS by RAHUL firstname.lastname@example.org
1.GLOSSARYAdverse Drug Reaction (ADR)Adverse Event (AE)Amendment (to the protocol)…………2.PRINCIPLESClinical trials should be conducted in accordance with the ethicalprinciples that have their origin in the Declaration of Helsinki, and thatare consistent with GCP and the applicable regulatory requirement(s).3.(IRB/IEC)An IRB/IEC should safeguard the rights, safety, and well-being of all trialsubjects. Special attention should be paid to trials that may includevulnerable subjects
4.INVESTIGATORThe investigator(s) should be qualified by education, training, and experienceto assume responsibility for the proper conduct of the trial, should meet allthe qualifications specified by the applicable regulatory requirement.The investigator should be thoroughly familiar with the appropriate use of theinvestigational product(s),5.SPONSORThe sponsor is responsible for implementing and maintaining quality assuranceand quality control systems with written SOPs to ensure that trials areconducted .
6.PROTOCOLThe contents of a trial protocol should generally include Protocol title,protocol identifying number, and date. Any amendment should also bearthe amendment numbers and dates.May be contained in other protocol referenced documents, such as anInvestigator’s Brochure .7.Investigators’ BrochureIts purpose is to provide the investigators and others involved in the trialwith the information key features of the protocol, such as the dose,dose frequency/interval, methods of administration and safetymonitoring procedures.
8.ESSENTIAL DOCUMENTSEssential Documents are those documents which individually andcollectively permit evaluation of the conduct of a trial and the quality of thedata produced.These documents serve to demonstrate the compliance of the investigator,sponsor and monitor with the standards of Good Clinical Practice and withall applicable regulatory requirements.