ICH ACRP Flashcards

LAR Legally Authorized Representative Essential documents documents which individually and collectively permit evaluation of the conduct of a study and quality of the data produced Who developed the Declaration of Helsinky? the World Medical Association Phase 1 study designed to determine the metabolic and pharmacologic action of the drug in humans monitor ultimately responsible for source data verification investigator leader of the research team who is responsible for the conduct of the clinical trial at the trial site sponsor individual, company, institution or organization which takes responsibility for initiation, management and/or financing of a clinical trial purpose of initiation visit to review protocol, SOPs, and blank CRFs purpose of IRB/IEC to protect subject safety purpose of source documentation to document the existence of study participants and substantiate the integrity of the study data collected DSMB data and safety monitoring board purpose of DSMB to assess the progress of a clinical trial, safety data, and critical efficacy endpoints sponsor responsible for providing the trial protocol phase 4 study designed for therapeutic use, begins after drug approval GCP international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects Phase 3 study determines therapeutic benefit and is usually conducted in larger, specific population Declaration of Helsinki WMA ethical principles for medical research involving human subjects Informed consent process by which a subject voluntarily confirms her or her willingness to participate in a clinical trial phase 1 study investigates human pharmacology, done in healthy subjects, initial administration of an IND in humans sub-investigator any individual member of the clinical trial team designated and supervised by the PI at a trial site to perform clinical trial-related procedures and/or to make important trial-related decisions mission statement of ICH to provide a unified standard for Europe, US and Japan to facilitate the acceptance of clinical trials What does the IRB/IEC evaluate? rights, safety and well-being of subjects participating in a trial, scientific tenability of the trial, subject selection procedure main concern of physician in any trial welfare of subjects ADR a noxious and unintended response to the investigational drug Subject ID number After a SAE, how should a subject be identified on the immediate and f/up reports? How should SAE be reported? to the IRB/IEC and to the sponsor What qualifications should a potential monitor provide proof od to be considered for the job? clinical, scientific and gcp knowledge Signatures needed on ICF person interviewing and subject Who communicates with IRB during trial? investigator 2 years minimal time essential documents should be retained after end of trial IRB approval format written source documents original and certified copies of documents, data and records, What does the PI do when a SAE occurs? inform sponsor and irb documents required by IRB for approval protocol and ICF criteria for classifying an AE as and ADR causal relationship is at least a reasonable possibility time when enrollment can start day of initiation visit purpose of a monitor ensure the correct compliant conduct of the project on behalf of sponsor details that should be documented when an AE occurs when, severity who are vulnerable subjects people in hierarchal structures: med students, pharmacy students, members of armed forces investigator's recording and reporting responsibilities all financial aspects, annual summary reports to IRB, written reports of changes or increased risk to IRB, final report at end of trial to sponsor investigator qualifications cv with education, training and experience; evidence of gcp compliance