rac us practice test

Regulatory Affairs Certification (RAC) US

What is RAC?

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Regulatory affairs (medical affairs) professionals (aka regulatory profession-als) usually have responsibility for the following general areas:

Ensuring that their companies comply with all of the regulations and laws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharma-ceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around is-sues such as the promotion of prescription drugs and Sarbanes-Oxley com-pliance

Certifications

Regulatory Affairs Certification (RAC)

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Question No 1:

Which is not a division of the FDA?

A. CDRHB. CDERC. CFERD. CVM

Answer: C






Question No 2:

What is the mission of the FDA?

A. Promote public healthB. Protect public healthC. Pursue international harmonizationD. All of the above

Answer: D






Question No 3:

Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?

A. Safe Medical Devices Act of 1990 (SMDA)B. Medical Device User Fee and Modernization Act of 2002 (MDUFMA)C. Federal Food, Drug, Cosmetic Act (FDC Act)D. Medical Device Amendments of 1976 (MDA)

Answer: D






Question No 4:

In order of highest level to lowest level, the ranking at US governmental organizations is:

A. Division, Office, Center, Agency, DepartmentB. Department, Agency, Center, Office, DivisionC. Center, Department, Division, Agency, OfficeD. Agency, Center, Office, Department, Division

Answer: B






Question No 5:

Your company is developing a new drug to be developed and used in combination with a cystoscopy light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is:

A. Submit a Request for Designation to FDA Office of Combination Products for determination of the lead

center for primary jurisdiction for the combination productB. Make a preliminary internal company determination of the combination product's primary mode of actionC. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug Prod-ucts (OODP)D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products

Answer: B


Question No 6:

For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at which of the following intervals?

A. 1 monthB. QuarterlyC. At completionD. Periodically

Answer: D






Question No 7:

Good Laboratory Practices Regulations govern the:

A. Conduct and control of laboratory activitiesB. Conduct of nonclinical laboratory studiesC. Determination of product efficacy in animalsD. Determination of product feasibility

Answer: B






Question No 18:

Consent from subjects for clinical study enrollment is a:

A. Proposed ruleB. Final ruleC. RecommendationD. Guideline

Answer: B






Question No 9:

All of the following are requirements of an IRB, EXCEPT

A. Has at least 5 membersB. Includes at least 1 nonscientific memberC. Obtains informed consent from all subjectsD. Represents the cultural mix of the community

Answer: C






Question No 10:

Financial Disclosure is required for investigators who, during the time the clinical investigator is car-rying out the study and for one year following the completion of the study, have:

A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USDB. Been paid $15,000 USD for conducting clinical trials with the sponsorC. A spouse who has been paid as a consultant by the company before the study beganD. Is not a requirement for Phase 2 studies

Answer: A






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Regulatory Affairs Certification (RAC) US

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