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SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE 15 0 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) ALREADY GRADED A+ The IRB will determine if a study is morally justified and demonstrates what key 4 items? - CORRECT ANSWER >>>>1. Adequate design

2. a favorable risk/benefit ratio
3. equitable selection of subjects
4. informed consent by subjects What all does the 1572 contain? - CORRECT ANSWER >>>>1. Name/Address of investigator
5. Name and protocol #
6. Name and address of every facility where clinical investigations will take place
7. Name/Address of any clinical lab
8. Name/Address of IRB
9. A commitment by the investigator

Common Deficienceis of FDA inspections - CORRECT ANSWER >>>>Failure to follow protocol, Deviations, Inadequate record keeping, Inadequate accountability, ICF issues/subject protections OHRP - CORRECT 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 - CORRECT 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/Purpose of IRB - CORRECT 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) - CORRECT ANSWER >>>>All noxious and unintended 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? - CORRECT ANSWER

Overall goals:

1. It is the structure of any scientific work. It gives direction and systematizes the research. Correlative Studies: 1.Observational 2.Cohort 3.Cross sectional What is an IDE? - CORRECT 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? - CORRECT ANSWER >>>>It is independent of and separate from routine monitoring 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 - CORRECT 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 - CORRECT 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 collected 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? - CORRECT ANSWER >>>>90 Days What should sponsor obtain from investigator regarding IRB? - CORRECT 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 - CORRECT ANSWER >>>>Investigators: 2 years after marketing applications 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 discontinues 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? - CORRECT ANSWER >>>>2 years. Can a clinical investigator submit an IDE? - CORRECT 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? - CORRECT ANSWER

1. Some 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? - CORRECT ANSWER >>>>Ensure human subject protection, data integrity, and product accountability

FDA jurisdiction for devices - CORRECT ANSWER >>>>FDA has jurisdiction at international sites where investigator is under an IDE What does a Phase I study entail? - CORRECT ANSWER

1. Initial introduction of investigational drug into humans.

2. Closely 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 - CORRECT ANSWER >>>>IRB must agre with this risk assessment. Does not meet significant device categories. What is the IEC? - CORRECT 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, regional, 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 protection. What does a Phase III study entail? - CORRECT 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 relationship.
5. Provide adequate basis for MD labeling.
6. Several hundred to several thousands of patients. Investigational Brochure (IB) - CORRECT ANSWER >>>>1. A compilation of the clinical and non clinical data on the investigational product that are relevant to the study of the products in human subjects. Purpose: to provide the investigators and others involved in the trial with the info to facilitate their understanding. What is included in the IB? - CORRECT ANSWER >>>>1. Brief description of drug substance/formulation.
7. Pharmacological/toxicological effects in animals.

3. Package/biological disposition in animals, humans as known
4. Summary of safety/effectiveness.
5. Possible Risks/side effects FDA Inspections - CORRECT ANSWER >>>>1. Bioresearch monitoring program conducts.
6. Usually occurs when NDA has been submitted for marketing approval.
7. Involve interviewers with research personel, review of reg. records, data, FDA/GCP guidelines. Study Oriented: Review of data that supports NDA, PMA, bioequivilance. Investigator Oriented: usually due to complaints, misconduct, fraud What would initiate the need for a protocol amendment? - CORRECT ANSWER >>>>1. znre protocol
8. Changes in protocol
9. New investigator
10. Content and format The sponsor must notify the FDA and investigators of potential serious risks ASAP - But no later than how many days? - CORRECT ANSWER >>>>15 calendar days (After sponsor determins info qualifies for reporting)

Descirbe the membership and reporting requrements of IRBs? - CORRECT ANSWER >>>>1. 5 members with varying backgrounds.

2. Mix of gender and professions.
3. Include at least (1) primary concern is scientific (1) whose primary concern is non-science
4. Include at least (1)not affiliated with institution or immediate family.
5. No member participation in initial or CR of any project in which there is conflict of interest.
6. At discretion they can invite people with competence in special areas for complex issues. Investigator Commitments on 1572 (CFR 312) - CORRECT ANSWER >>>>1. Will conduct study according to protocol and only make adjustment if sponsor is notified or to protect health of subjects.
7. Comply with all CFR pt 312.
8. Will inform subjects that drugs are used for investigational purpose and requirements for IRB and ICF are met.
9. Will report AEs to sponsor.
10. Will ensure all associates, colleagues, employees are informed of commitments to study. IRB will do initial/ongoing approvals of study and investigator will report and changes or unanticipated problems.
11. IRB will be used and complies.

What is the purpose of monitoring? - CORRECT ANSWER

1. To verify that the rights and well being of human subjects are protected.

2. The reported trial data are accurate, complete, and verifiable from source documents.
3. The conduct of the trial is in compliance with the currently approved protocol/amendments with GCP, and with the applicable reg requirements. Belmont Report: Beneficence - CORRECT ANSWER >>>>1. To secure patient well being.
4. To cover acts of kindness or charity that go beyond strict obligation.
5. Do not harm.
6. Maximize possible benefit - minimize possible harm. What is a CRO? - CORRECT ANSWER >>>>Contract Research Organization. A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of the sponsor. Ex: Design of protocol, selection of monitors of investigators, evaluation of report, prep of materials to be submitted to the FDA.

What critical question must be answered by the IRB? - CORRECT ANSWER >>>>Does the sum of the benefits and the importance of the knowledge gained from research outweigh the risks to the participants. Definition of Audit - CORRECT ANSWER >>>>Systematic inddependent exam of trial related activities and documents to determine compliance with sponsor SOPs/GCPs. Sponsor or CRO performs. Verify data integrity. Definition of Inspection - CORRECT ANSWER >>>>Protection of human subjects, verify Data act by regulatory authorities of official review of documents, facilities, records, any other resources. May affect decision to accept data for marketing. Definition of Monitoring - CORRECT ANSWER >>>>Act of overseeing progress of trial and ensuring it is conducted, recorded, reported in accordance with protocol, SOPs, GCPs. Sponsors. Assume compliance on ongoing basis. Miscelaneous - CORRECT ANSWER >>>>1. A duly constituted IRB must include at least 3 non-affiliated members who shall not be employees or officers of the federal government.

2. If use of the investigational device, in the opinion of the investigator required to preserve the life of a subject and time is not sufficient, the determination of the investigator shall be made within 5 working days after the use of the

device - written certification is required to the FDA - IRB by the investigator within 5 days (working) after the use for the device. what is included in Trial Design? - CORRECT ANSWER >>>>1. Sponsor utilizes qualified individuals throughout all stages of trial process.

2. Designing protocol.
3. Designing CRFs.
4. Planning Analysis.
5. Planning/preparation interim and final reports. Selecting Investigators and Monitors (CRO or Sponsor) Pt 312 - CORRECT ANSWER >>>>1. A sponsor should select only investigators qualified by training/experience.
6. Drug must only be shipped to investigator on trial.
7. Must obtain from investigator: 1572/FDFs/CV IRB review of research - CORRECT ANSWER >>>>1. Review/Have the authority to approve, require modifications or disapprove research.
8. Require ICF information follow 116.
9. Require documentation of ICF.
10. Notify investigators/institutions of decision in writing. If disapproved, must give reasons. Give inv. opportunity to respond.
11. Conduct continuing review no less than 1x per year.

Prompt Reporting Guidelines - CORRECT ANSWER >>>>1. Unanticipated.

2. Indicate that the research places subjects or others at greater risk of harm (including, physical psychological, economic, or social harm) that was previously known or recognized. (Think any "new risk".). Prompt Reporting to the IRB - CORRECT ANSWER >>>>1. Deviations from or changes of the protocol to eliminate immediate hazards to the trial subjects.
3. Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial.
4. All adverse drug reactions (ADR) that are both serious and unexpected.
5. New info that may affect adversly the safety of the subjects or the conduct of the trial. IRB Registrations - CORRECT ANSWER >>>>IRB under OHRP that review research involving humans must be registered Dept. of health and human services (HHS).
6. Name, address, institution, contact info of head official.
7. Contact info for who is doing registration.
8. Contact info for chairperson.

9. of protocols, active protocols, # of IRB positions.

5. Type of products for protocols they review. OHRP approves registration- effective for 3 years. Additional Elements of ICF that should be provded (CFR 46) - CORRECT ANSWER >>>>1. Treatment may involve risks which are currently unforeseeable.
6. Subject protection may be terminated by investigator.
7. Additional costs that may result from participation.
8. Consequences of withdrawing or termination.
9. New findings will be provided when they may offset willingness to participate.
10. Number of subjects involved. Expanded Access to Investigational Drugs Requirements - CORRECT ANSWER >>>>Meant to facility availability of drugs to patients with serious diagnosis or conditions and there is not alternative. Drugs with limited availability by REMS.
11. Patients have serious or immediately life threatening condition with no alternatives.
12. Benefit justifies risk of treatment use and potential risks are not unreasonable.
13. Providing the drug for use will not interfere with clinical investigations or compromise potential development.
14. Expanded access submission submitted. Goes into effect 30 days after FDA reviews.

What are the IRBs responsibilities when ICF cannot be obtained in emergency situations - CORRECT ANSWER

Must ensure procedures are in place to inform at earliest time the subject or LAR of the subjects participation in the study. IRB determinations of this must be retained for 3 yrs. Must document: Life treatening. ICF is not feasible. Research will cause direct benefit. Waiver not practical. What are the contents of an IND application? - CORRECT ANSWER >>>>1. 1571. Name of sponsor, phase of study, will wait for IND approval, IRB responsible, Name of people monitoring, who is evaluating safety, statement of any transferred responsibilities, signature.

2. Table of contents.
3. Intro statement.
4. IB.
5. Protocol.
6. Chemistry, manufacturing, control info.
7. Pharmacology, toxicology info. Declaration of Helsinki (1964) Ethical principles for medical research addressed primarily to physicians - CORRECT ANSWER >>>>1. Health of patient is 1st consideration.
8. Duty of physicians to provide and safeguard health and well being.

3. Number 1 purpose of research is to understand causes, development, effect of disease and improve prevention, diagnoses and interventions.
4. new research knowledge is never greater rights of interests of subjects.
5. Duty of physicians to protect health, life, dignity, integrity, privacy and confidentiality.
6. Research should be done so as to minimize possible harm. What are the 8 basic elements of the informed consent? - CORRECT ANSWER >>>>1. A statement that study involves research explanation of procedures, purpose, participation.
7. A description of risks.
8. A description of benefits.
9. A description of alternative procedures/treatments.
10. Confidentiality.
11. If involves more that minimal risk - medical treatment/compensation involved.
12. Study contact questions.
13. Participation is voluntary. What are information amendments (312, IND) - CORRECT ANSWER >>>>A sponsor must report information on the IND that is not within scope of protocol amendment. Ex:
14. Toxicology, chemistry technical info.

2. Report for discontinuation of investigation. What should a protocol contain? - CORRECT ANSWER

1. Objectives and purpose of study.

2. Investigators information - address, name, etc.
3. Criteria for pt. selection and # of pts.
4. Description of study design.
5. Method of determining dosage - max dose/duration.
6. Observations and measurements.
7. Description of clinical procedures. Responsibilities of sponsors ( CFR pt 312) - CORRECT ANSWER >>>>1. Select Qualified Investigators
8. Provide investigator with info they need to conduct trial.
9. Proper monitoring.
10. Maintain IND (amendment/renewals).
11. Notify FDA and all investigators of significant AEs or updated risk information of drug.
12. Protocol/investigational plan is followed. (Some of these can be transferred to the CRO) How long does the sponsor have to notify the FDA about a protocol amendment for an investigator change? - CORRECT ANSWER >>>>30 days Protocol Amendments (sponsor can amend as needed the protocol to ensure investigations are conducted according

to protocol in application) - CORRECT ANSWER >>>>A sponsor shall submit an amendment when there is any change that affects patient safety.

1. Increase in drug dosage or exposure.
2. Increase in number of subjects in study.
3. Addition of any new test or procedure (must submit to FDA and must be IRB approved).
4. Change in design of protocol. If change in protocol has to be done immediately to protect subjects they can be notified ASAP. New investigator - > sponsor must notify FDA within 30 days. Humanitarian Use Device - CORRECT ANSWER >>>>1. Treatment of diagnosis in condition affecting fewer than
6. FDA responds in 45 days.
7. HDE not equal to IDE. Only needs to address safety. The sponsor should obtain the investigators agreement for a new trial based on what 4 criteria? - CORRECT ANSWER

1. To conduct the trial in compliance with GCP, with the applicable reg requirements, and with the protocol agreed to by the sponsor.

2. to comply with procedures for data recording/reporting.
3. to permit monitoring, auditing, and inspection.

4. to retain trial related essential documents until sponsor informs investigator these are no longer needed. 2 common routes for a device to go to market - CORRECT ANSWER >>>>1. Premarket notification (SIO). FDA determines device is equivalent to device already allowed on market. Can enter market without clinical trials.
5. Pre-market approval (PMA) - similar to NDA. FDA reviews all clinical investigations. What is the sponsor responsible for in terms of electronic data systems? - CORRECT ANSWER >>>>1. Ensure and document electronic system is complete, accurate, and consistent.
6. Maintain SOPs for system.
7. Data changes are documented, no deletion of data.
8. List of authorized individuals. Expanded Use Criteria - CORRECT ANSWER >>>>1. Patient has life threatening diagnosis or condition.
9. Benefit outweighs risks.
10. Providing investigational drug for requested use. 1571 = IND Application (Expanded Use) - CORRECT ANSWER

Cover sheet for expanded access submissions includes:

1. Rationale of intended use of drug.

2. Criteria for client selection.
3. Method of administration.
4. Description of facility where drug-manufactured.
5. chemistry...strength of investigational drug.
6. Pharmacology/toxicity Serious Reporting Examples (Flip to see) - CORRECT ANSWER >>>>Information that might materially influence the benefit risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such examples:
7. unexpected, serious ADR, an increase in the rate of occurrence which is judged to be clinically important.
8. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treatment of life threatening disease.
9. A major safety finding from a newly completed clinical study (such as carcinogenicity). ISO 14155:2011 GCP - CORRECT ANSWER >>>>Overuse of investigational device. SADE reporting. IB contents. Ament internationa standard for devices. Does not apply to invitro medical devices.

IND Annual Reports and Withdraw - CORRECT ANSWER

1. Sponsor shall within 60 days of when IND went into effect, submit brief report of progress of investigation. Study info-status of each study. Summary of information. Protocol modification. IB Updates. SAEs/Deaths/Enrollment.

2. Sponsor may withdraw IND at any time without prejudice. FDA notified. Clinical investigators notified.
3. If W/D for safety, FDA should be told, also IRB Definition of Minimum Risk - CORRECT ANSWER

Probability and magnitude of harm or discomfort Information that might materially influence the benefit risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such examples: 1. unexpected, serious ADR, an increase in the rate of occurrence which is judged to be clinically important. 2. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treatment of life threatening disease. 3. A major safety finding from a newly completed clinical study (such as carcinogenicity). ISO 14155:2011 GCP - CORRECT ANSWER >>>>Overuse of investigational device. SADE reporting. IB contents. Ament internationa standard for devices. Does not apply to invitro medical devices. IND Annual Reports and Withdraw - CORRECT ANSWER >>>>1. Sponsor shall within 60 days of when IND went into effect, submit brief report of progress of investigation. Study info-status of each study. Summary of information. Protocol modification. IB Updates. SAEs/Deaths/Enrollment. 2. Sponsor may withdraw IND at any time without prejudice. FDA notified. Clinical investigators notified. 3. If W/D for safety, FDA should be told, also IRB Definition of Minimum Risk - CORRECT ANSWER >>>>Probability and magnitude of harm or discomfort anticipated in research are not greater than those encountered in daily life or with routine tests/procedures. Clinical Trial Phases - CORRECT ANSWER >>>>Phase 1: Healthy Volunteers. Toxicity. PK/PD Profiles. Determine Dose. Protocol design is less structured. Phase 2: short term risks. Effectiveness. Phase 3: Determine effectiveness. Confirm Phase 2. The FDA will not disclose the existence of an IDE unless: - CORRECT ANSWER >>>>1. FDA determines that information has been previously disclosed to public.

2. FDA approves a PMA for a device subject to an IDE or.

3. A notice of completion of a product development protocol (PDP) is in effect. What are prompt reporting guidelines? - CORRECT ANSWER

1. Unanticipated.

2. Research places subjects or others at greater risk of harm. Examples: Deviations or changes to protocol to eliminate immediate hazards to trial subjects. Changes that increase risk to subjects or affect conduct of trial. Adverse Drug reactions (serious/related/unexpected). New info that could affect safety of subjects. What is the notification process of an exception to informed consent occurs? - CORRECT ANSWER >>>>IRB to provide in writing to sponsor than sponsor should disclose to FDA. Determinaton of investigator to use the device must be made in 5 working days of using device to IRB. Belmont Report: Justice - CORRECT ANSWER >>>>Who ought to receive the benefits of research and bear its burdens? "fairness in distribution" or "what is deserved". Equals ought to be treated equally.
3. To each an equal share.
4. To each according to individual need.
5. to each according to individual effort.

4. to each according to societal contribution.
5. to each according to merit. Nuremberg code - CORRECT ANSWER >>>>10 ethical principles set out at the end of WWII - 1947.
6. consent of human subjects is essential
7. Experiment must yield results good to society.
8. Experiment should be designed based on animal experiments that justify experiment.
9. Should avoid all unnecessary physical and mental suffering.
10. No a priori reason that death or disabling injury will occur.
11. Risk should not be greater than humanitarian importance of problem.
12. preparations/facilities proposed to protect against injury, death.
13. Only conducted by qualified people.
14. Subject can end experiment at anytime.
15. Scientist in charge must terminate experiment if needed. What is non-compliance - CORRECT ANSWER

Noncompliance with the protocol, SOPs, and GCP and/or applicable regulatory requirements by an investigator institution or by members of the sponsors staff should lead to prompt action by the sponsor to secure compliance.

Required components of a Protocol (IND app/312) - CORRECT ANSWER >>>>1. statement of objectives/purpose.

2. Name/address/statement of qualifications of each investigator.
3. criteria for patients selection/inclusion and # of patients enrolled.
4. Description of study design.
5. method for determining dose to be administered, planned max dose and duration of exposure.
6. description of observations and measurements.
7. clinical procedures, lab tests to monitor effects of drug. Confirmation of review by IRB/IEC. The sponsor, should obtain from the investigator/institution? - CORRECT ANSWER >>>>1. Name/Address of investigator/institution.
8. A statement obtained from the IRB, that it is organized and operates according to GCP and the applicable laws and regulations.
9. documented IRB/IEC approval. Protocol and ICS. What two categories does the FDA place all approved IDE's?

• CORRECT ANSWER >>>>1. Category A(Experimental): Absolute risk has not yet been established.

2. Category B (Investigational; non-experimental): Involves device types to be in classes I or II or in class III where incremental risk is the primary risk.

When can the IRB use expedited review? - CORRECT ANSWER >>>>1. Some or all research appears on the list and found by the reviewers to involve no more than minimal/risk.

2. minor changes in previously approved research during the period (1 yr or less) for which approval is authorized. When can a sponsor withdraw an effective IND without prejudice? - CORRECT ANSWER >>>>ANYTIME.
3. If withdrawn, FDA must be notified.
4. All study procedures end.
5. Investigators and IRB notified. IRB General Definition - CORRECT ANSWER >>>>an independent body constituted of medical, scientific, and non-scientific members whose responsibility it is to ensure the protection of the rights, safety, and well being of human subjects. Renewing approving and providing CR and protocol amendments. IDE application is required when? - CORRECT ANSWER

1. Device is intended to treat or diagnose a serious or life threatening disease.

2. No comparable or satisfactory alternative device.
3. Device is under investigation in controlled clinical trial.