SOCRA CCRP Test Questions with Correct Solutions | Graded A+

Contract Research Organization - A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - False-they must sign both What is FDA form 3454 - Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the Belmont Report? - Respect for persons. Beneficence. Justice. Phase III - Study Participants: 300 to 3,000 volunteers who have the disease or condition Length of Study: 1 to 4 years Purpose: Efficacy and monitoring of adverse reactions Phase I - 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Phase II - Study Participants: Up to several hundred people with the disease/condition. Length of Study: Several months to 2 years Purpose: Efficacy and side effects The main concept of 21 CFR 50 is - protection of human subjects 21 CFR 50 part D - protection of childern A____________ can be any unfavorable and unintended sign) including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. - adverse event The FDA form 483 is used for _______ - Inspectional oberservation The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as - GCP A(n) _________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial. - comparator What is 21 CFR 50.23 Subpart B? - the exception to the general requirements This form is used for the voluntary reporting of adverse events and product problems - 3500 is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial - direct access 21 cfr part b - ICF Belmont Report (1979) - respect for persons, beneficence, justice significant risk device - s a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating A ________is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject - crf sae form - 3500a The sponsor shall notify the FDA by telephone or fax any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than _____ after the sponsor's initial receipt of the information - 7 days Unexpected serious suspected adverse reactions and observations from animal studies suggesting significant risk to human subjects must be reported to FDA as soon as possible but no later than within __ calendar days following the sponsor's initial receipt of the information. - 15 days the sponsor must notify FDA of any UNEXPECTED FATAL LIFE THREATENING SUSPECTED adverse reactions ASAP but no later than __calendar days following the sponsor's initial receipt of the information - 7 days Follow-up IND Safety Report. Such report should be submitted without delay, as soon as the information is available but no later than __calendar days after the sponsor receives the information. - 15 days What date should an investigator write when he failed to sign the consent form on the date of consent? - date of investigators signature for MEDICAL DEVICE trials the P.I. should submit to the sponosr & IRB a report of any unanticapted adverse asap but no later than___ - 10 days assent - means a child's affirmative agreement to participate in a clinical investigation. consent from 1 or both parents or LAR is required