SOCRA Practice Test Questions With Verified Solutions

SOCRA Practice Test Questions With Verified Solutions Which of the following is a disclosure of financial interests form? - answerFDA Form 3455 Which of the following is a certification of financial interest form? - answerFDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - answerFDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - answerInvestigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? - answerOffice of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is - answer3500 Medical device adverse events/problems are reported via a form: - answer3500A What is FDA form 1571? - answerCover-sheet for Investigational New Drug Applications 21 CFR 312 deals with - answerInvestigational New Drug Application Investigational new drug means - answerA new drug or biological drug that is used in a clinical investigation The immediate package of an investigational new drug intended for human use shall bear a label with the statement - answer"Caution: New Drug—Limited by Federal (or United States) law to investigational use." Which of the following is not listed on FDA form 1571: - answerApproved informed consent document "Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred" Is... - answerLife threatening adverse drug experience What are the three main basic ethical principles of the Belmont Report? - answer1. Respect for Persons 2. Beneficence 3. Justice What are the applications for the Belmont Report? - answer1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects What phrase of a drug trial usually includes hundreds to thousands of volunteers? - answerPhase 3: These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs. What is a drug as defined by the FDA? - answerA drug is an product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body. What is Phase 1 of a clinical trial? - answer20-80: Typical number of healthy volunteers used in Phase 1: this phase emphasizes SAFETY. What is Phase 2 of a clinical trial? - answer100s: Typical number of patients used in Phase 2; this phase emphasizes EFFECTIVENESS What is Phase 3 of a clinical trial? - answer1000's :Typical number of patients used in Phase. 3. These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs. What is Phase 4 of a clinical trial? - answerPost Marketing: Because it's not possible to predict all of a drug's effects during clinical trials, monitoring safety issues after drugs get on the market is critical. The role of FDA's post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed. The main concept of 21 CFR 50 is - answerProtection of Human Subjects Subpart D of 21 CFR 50 lists the - answerAdditional Safeguards for children in Clinical Investigations The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subject - answera. true X (21 CFR 56.110 Subpart D) b. false A Phase ___ protocol is more flexible and less detailed than the others. - answerPhase 1 A source document is any document found that is associated with a clinical trial. - answera. true b. false X (A source document is any document where the date are FIRST recorded)