ACRP ICH Flashcards Challenge|100% PASS|ALREADY GRADED A

Who is responsible for providing the trial protocol The Sponsor Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced are called..? Essential documents 00:27 01:11 All information in original records and certified copies of original records of critical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial are called..? Source Data One of the primary purposes of a Phase I study is to determine the metabolic and pharmacologic action of the drug in humans. True The purpose of the IRB/IEC is to project subject safety. True Who is ultimately responsible for SDV? The Monitor Most typical study, investigates human pharmacology. It is the initial administration of an investigational new drug into humans. It is most commonly done in healthy subjects. Which phase if this? Phase I What is the minimum number of members on an IRB/IEC? 5 The purpose of ICH-GCP is to standardize the design, conduct, recording and reporting of clinical trials. True The purpose of the DSMB is to assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints. True The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as.. Informed Consent The Declaration of Helsinki was developed by... The World Medical Association 00:00 01:11 Which phase determines therapeutic benefit and is usually done in a larger, specific population? Phase III An individual, company, institution or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial is called the.... Sponsor The main goal of this phase of drug development is to explore therapeutic efficacy in patients. It is important during this phase to determine the dose(s) and regimens that will be used for later trials. Phase II What should the main concern of physicians be in a clinical trial? Subject welfare Documents that the investigator is obliged to comply with during the trial.. The trial protocol, ICH-GCP, all applicable laws and regulations Which phase allows for therapeutic use and begins after drug approval? Phase IV What does the IRB/IEC evaluate? The rights, safety and well-being of the subjects participating in the trial, the scientific tenability of the trial and the subject-selection procedure The WMA (World Medical Assn) ethical principles for medical research involving human subjects is called? The Declaration of Helsinki What is the purpose of the initiation visit? To review the protocol, standard procedures and blank CRFs Providing a unified standard for Europe, US and Japan to facilitate the acceptance of clinical trials is the mission statement of... The ICH Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. (T/F) True