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SOCRA Certification Questions and Answers 100% Verified | Latest Update 2023
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SOCRA Certification Questions and Answers 100% Verified | Latest Update 2023
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By: clarity142 • 6 months ago
By: alphikuriakose02 • 9 months ago
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SOCRA Certification Questions and Answers 100% Verified | Latest Update 2023 The IRB will determine if a study is morally justified and demonstrates what key 4 items? - Answer 1. Adequa te design 2. a favorable risk/benefit ratio 3. equitable selection of subjects 4. informed consent by subjects What all does the 1572 contain? - Answer 1. Name/Address of investigator 2. Name and protocol # 3. Name and address of every facility where clinical investigations will take place 4. Name/Address of any clinical lab 5. Name/Address of IRB 6. A commitment by the investigator Common Deficienceis of FDA inspections - Answer Failure to follow proto col, Deviations, Inadequate record keeping, Inadequate accountability, ICF issues/subject protections OHRP - Answer Office For Human Research Protections. 1. Protects volunteers in research conducted supported by US Dept. of Health and Human Services 2. Usually inspects IRBs Definition of IRB approval - Answer Affirmative decision of IRB that clinical trial has been reviewed and may be conducted at the institution site with in constraints set forth by IRB, institution and GCP What is the Role/Purpo se of IRB - Answer 1. Assure Protection of Human subjects, rights, and well being 2. Determine if research is a benefit to participants, does not cause harm, and promotes good clinical practice Adverse Drug Reaction (ADR) - Answer All noxious and uni ntended responses to a medicine/product related to any dose. Relationship between medicinal product and AE's is a reasonable possibility. (the relationship cannot be ruled out) Discuss the basics of study design? - Answer Overall goals: 1. It is the st ructure of any scientific work. It gives direction and systematizes the research. Correlative Studies: 1.Observational 2.Cohort 3.Cross sectional What is an IDE? - Answer Investigational Device Exemption. It permits a device that otherwise would be required to comply with a performance standard or to have pre -market approval to be shipped lawfully for the purpose of conducting investigations of that device. What is the purpose of an audit? - Answer It is independent of and separate from routine mo nitoring or quality control functions, should be used to evaluate trial conduct and compliance with the protocol SOP's, GCP, and the applicable regulatory requirements. Significant Risk Device - Answer IDE must be submitted. 1.Implant or serious risk to health, safety, well -being 2.Supports/sustains human life 3.Importance for diagnosis, treatment, or curing diseases. Could be class II or class III. IRB makes determination when FDA hasn't already. Criteria for IRB Approval - Answer 1. Risks to subjects are minimized 2.Risks are reasonable in relation to benefits. 3. Selection of subjects is equitable. 4.ICF is obtained from each subject or LAR. 5.ICF is appropriately documented. 6.Research plan includes monitor data c ollected to ensure subject safety 7.Adequate protection of privacy and confidentiality of data -> additional safeguards for vulnerable populations. How many days must the IRB revise its registration information? - Answer 90 Days What should sponsor ob tain from investigator regarding IRB? - Answer 1. Name/Address of IRB 2. Statement from IRB that it is organized and complies with GCP 3. Documented approval of ICS and Protocol Record Keeping - Answer Investigators: 2 years after marketing applicat ions approval or 2 years after investigation is discontinued and FDA is notified. Sponsor: Should maintain all sponsor specific docs for at least 2 years after they discontinue development. IRB: 3 years after completion of research. If a sponsor discont inues the clinical development of an investigational product (i.e.) for any or all indications, routes of admin, dosage forms) the sponsor should maintain all sponsor specific essential documents for at least how many years? - Answer 2 years. Can a clin ical investigator submit an IDE? - Answer Yes. They can sponsor their own study. They are considered a sponsor -investigator and must comply with all responsibilities of both sponsor and investigator. IRB can use expedited reviews when? - Answer 1. Som e or all of research involved no more than minimal risk. 2.Minor changes in previously reviewed research during period of 1 year or less for which approval is authorized. 3. Can be carried out by IRB chairperson or by one or more experienced reviewers. Reviewer cannot disapprove on their own. What do audits, inspections, and monitoring visits have in common? - Answer Ensure human subject protection, data integrity, and p roduct accountability FDA jurisdiction for devices - Answer FDA has jurisdiction at international sites where investigator is under an IDE What does a Phase I study entail? - Answer 1. Initial introduction of investigational drug into humans. 2. Clo sely monitored 3. Patients or normal volunteers. 4. Designed to determine metabolism and pharmacologic actions of drugs in humans. 5. Side effects and increasing doses 6. Gain early evidence on effectiveness 7. drug metabolism structure activity 8. research tools. 9. 20 -80 patients. Non-Significant Device - Answer IRB must agre with this risk assessment. Does not meet significant device categories. What is the IEC? - Answer Independent Ethics Committee. A review panel that is responsible for ensuring the protection of the rights, safety and well being of human subjects involved in a clinical investigation and is adequately constituted to provide asurance of that protection. An independant body ( a review board, comittee, institutional, regiona l, national, supre -national) constituted of medical professional and non -medical members whos responsibility it is to ensure the protection of the rights, safety, and well being of human subjects invovlved in a trial and provide public assurance of protect ion. What does a Phase III study entail? - Answer 1. Expanded controlled and uncontrolled studies. 2. After preliminary evidence of drug effectiveness. 3. Gather additional information (effectiveness or safety) 4. Evaluate overall benefit -risk relati onship.
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