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CRS exam 2 Actual Questions and Answers 2024/2025 with complete solutions;100% verified

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Which document demonstrates that the PI has the education, training, and experience to be an expert in the clinical investigation of the drug under investigation? - Curriculum Vitae (CV) Which activity does FDA believe can be done better through the use of remote monitoring? - Analyzing site performance metrics, and clinical data to identify trial sites that have poor performance or potential noncompliance What should a sponsor do when they discover a PI is not complying with the general investigational plan? - Promptly secure compliance or discontinue shipments of investigational new drug All individuals involved in clinical research have a role in: - Helping to develop safe and effective therapies while ensuring the rights, safety, and welfare of the subjects have been protected According to the article, which non entry-level clinical research role needs to be able to point out the deficiencies related to the work of others and hence must not be adverse to conflict? - Quality Assurance Auditor In which field are product development timelines typically shorter? - Medical Device Who has the responsibility to protect human subjects? - All people involved in clinical research It is OK for a sponsor to transfer some obligations to a contract research organization verbally - False FDA is allowed to inspect the sponsor or the site at any reasonable time - TrueFor how long must the investigational site retain records if the drug under study is not approved for the study indication? - 2 years after the investigation is discontinued and FDA is notified which of the following should be used to determine the extent and nature of monitoring? - The purpose, complexity, and endpoints of the study true or false: the clinical trial monitor must ensure that they are informing the FDA of any CRF entry error they find during the course of clinical trial monitoring. - False which of the following should be included on the monitoring visit report? - Name of the PI at the site What is one reason that FDA has encouraged sponsors to adopt a risk-based approach to clinical trial monitoring? - FDA believes that risk-based monitoring will improve sponsor oversight of clinical trials What should the sponsor consider during the identification of critical data and processes? - The quantity and type of source data that needs to be verified When the sponsor is identifying critical data to determine the best approach to monitoring, which of the following would be considered critical? - verification of informed consent What is the next step the sponsor should take after identifying critical data and processes? - Conduct a risk assessment to identify potential risks that may affect the collection of critical data Which of the following should be considered when developing a monitoring plan? - Complexity of the study design Types of study endpoints If the sponsor of a clinical trial is planning on delegating the tasks of monitoring the clinical trial to a contract research organization, what do FDA regulations require that they do? - Have a written transfer of obligations from the sponsor to the CROTrue of False: adverse drug reactions which are serious and expected must be reported promptly to the IRB by the investigator - False For how long should the IRB/IEC retain all relevant records? - For at least 3 years after completion of the trial Which of the following would be an appropriate IRB/IEC roster at a Helping Hands Hospital (a fictional institution)? - A physician from the neurology department, a first grade teacher, two nurses from the emergency department, and a private practice cardiologist Which of the following are true regarding payments to subjects - The IRB must review the method of payment Payments must be prorated The IRB must review the amount of payment Payments must be set forth in the informed consent form How often must the IRB conduct continuing review of each ongoing trial? - at least once per year What are the most important considerations to be taken in clinical trials? - Rights of the subject Well-being of the subject Safety of the subject This person is always responsible for the medical care given to, and the medical decisions made on behalf of subjects - A qualified physician Why does Dr. Beecher state that he is calling attention to ethical errors through his article? - Pressures on young physicians to prove themselves as investigators Requirements and resources are greater than supply of responsible investigators Growing emphasis that experimentation in humans must come before applying new procedures in therapyIncrease in available research funds Dr Beecher cites a 1964 study of 100 human studies published in a reputable journal - of these studies, how many seemed to be unethical? - 12 "a far more dependable safeguard than consent is the presence fo a truly _____ investigator" - responsible What accounts for most of the unethical cases encountered in Dr. Beecher's study? - Thoughtlessness and carelessness

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PCB CRS- EXAM
12 Core Competency Areas (SAMHSA) - Category 1: Engages peers in collaborative and caring
relationships

Category 2: Provides support

Category 3: Shares lived experiences of recovery

Category 4: Personalizes peer support

Category 5: Supports recovery planning

Category 6: Links to resources, services, and supports

Category 7: Provides information on skills related to health, wellness, and recovery

Category 8: Helps peers to manage crises

Category 9: Values communication

Category 10: Supports collaboration and teamwork

Category 11: Promotes leadership and advocacy

Category 12: Promotes growth and development




❈ Disclosure - Communication of records containing "patient-identifying information" >
Disclosure Example: even if person receiving the information already has it ("I dropped off my wife
earlier today. Is she finished with treatment today?")



❈ 28 Pa Code §709.28 (State Confidentiality Regulation) - • Licensing Code relating to two main
issues:

- Confidentially of client identify and records

- Staff access to client records



❈ 4 Pa Code §255.5 - (State Regulation -Management Information, Research, & Evaluation)

• State regulations which are more strict that the Federal Regulations are followed

• These regulations protect the client

• Restrictions and The Big 5

,• Documentation for everything that is released.



❈ 42 CFR II (Federal Regulations) - Implement 42 U.S.C. 290dd-2 & Outline limited circumstances
where info about treatment may be disclosed w/out person's consent.

• The federal regulation at 42 CFR Part 2 pertains to any program that involves substance abuse
education, treatment, or prevention and is regulated or assisted by the federal government.

> Purpose: these regulations impose restrictions upon the disclosure and use of alcohol and drug abuse
patient records which are maintained in connection with the performance of any federally assisted
alcohol or drug abuse program

> Effect: these regulations prohibit the disclosure and use of patient records unless certain circumstances
exist.

> Scope of the Law: Restricts the disclosure and use of "patient identifying: information about individuals
receiving, having received, or having applied to receive substance abuse treatment.



❈ 42 Pa Code §6352.1 (Act 126) - • Allows for the release of drug and alcohol treatment and
other records regarding a child who is alleged to be or adjudicated dependent or delinquent, or the
child's parents, to an extent not permitted in other proceedings or anywhere else in Pennsylvania.

• Still obtain releases!



❈ 42 U.S.C. 290dd-2 (Federal Law) - Governs Confidentiality in Substance Abuse Field

• Programs may not disclose any information identifying a patient as an alcohol or drug abuser unless:

- The patient consents in writing,

- The disclosure is allowed by a court order, or

- The disclosure is made to medical personnel in a medical emergency or to qualified personnel for
research, audit, or program evaluation



❈ 55 Pa Code §5100.37 - (State MH Regs.)

• Whenever information in a patient's records relates to drug or alcohol abuse or dependency, those
specific portions of the patient's records are subject to the confidentiality provisions of section 8(c) of
the Pennsylvania Drug and Alcohol Abuse Control Act (Act 63) and the regulations promulgated
thereunder, 4 Pa Code §255.5

"Federally assisted" - 1. Allowed tax deductions for contributions by the IRS

2. Authorized to conduct business by the federal government, including programs:

, >> Certified as a Medicare provider

>> Authorized to conduct methadone maintenance treatment

>> Registered with the DEA



❈ 71 P.S. §1690.108 (Act 63) - State law relating to the Confidentiality of Records of Substance
Abuse Treatment Services

• State's Enabling Legislation

• Minors in PA can receive treatment without parental consent

- Differs that MH regulations

- Minors control release of information



❈ Authorized personnel: - The power to determine, adjudicate, or settle disputes, jurisdiction, the
right to control, command, or determine.

- A power or right delegated or given, authorization

- A person or group w/ authority as a government agency

- Usually authorities, w/ legal power to make/enforce laws

- An accepted source of information, advice, etc.



❈ Confidentiality: - Ensures that information is only accessible to those w/ authorized access.

- Linked w/ ethical communication principle that's "privileged" & not shared w/ 3rd parties.

- The responsibility for limiting disclosure of private matters.




❈ Minimum amount of information: - Information needed to carry out purpose of the disclosure



❈ Patient - Anyone who now or ever received - or even applied for - services from a Part 2
alcohol/drug program.

- Example: John made appointment but didn't show up. He's a "patient."

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