SOCRA 2024 Flashcards
What is 21 CFR 11?
Electronic Records; Electronic Signatures
What is 21 CFR 50?
Informed Consent
What is 21 CFR 54?
Financial Disclosure
What is 21 CFR 56?
Institutional Review Boards
What is 21 CFR 312?
Investigational New Drug Application
What is 21 CFR 314?
New Drug Application
What is 21 CFR 812?
Investigational Device Exemption
What is 21 CFR 814?
Premarket Approval of Medical Devices
What is 45 CFR 46?
Federal Research
“The Common Rule”
What countries adhere to ICH E6 GCP?
- European Union
- Japan
- Unites States
- Australia
- Canada
- Nordic Countries
- World Health Organization
What does ALCOA-C stand for?
Attributable, Legible, Contemporaneous, Original, Accurate, Complete
What year did the Nuremberg Code come out?
1947
What foundation of ethical research come out during WWII?
The Nuremberg Code
What is the core principle of the Nuremberg Code?
Informed Consent - Voluntary consent of the human subject is absolutely essential.
Who wrote the World Medical Association (WMA)?
The Declaration of Helsinki
What year did The Belmont Report come out?
1974
What are the three basic ethical principles of The Belmont Report?
- Respect for Persons
- Beneficence
- Justice
What is Respect for Persons (Belmont Report)?
Individuals should be treated as autonomous agents capable of deliberation about personal goals. This is all about respect for autonomy of the person.
What is Beneficence (Belmont Report)?
Persons are treated in an ethical manner not only for respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
Example: do not harm, maximize possible benefits and minimize possible harms.
What is Justice (Belmont Report)?
Fairness in distribution of burdens and benefits.
who’s responsibility is it to obtain the signed 1572 (pharmaceutical investigation) or Investigator Agreement (device investigation)?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
What does the Investigator’s Agreement contain?
- CV
- Statement of Investigator’s relevant experience
- Explanation of termination circumstances
- Statement of the Investigator Commitment
Who can the Sponsor transfer any or all of their responsibilities to?
Contract Research Organization (CRO)
Who is responsible for proper monitoring and providing a monitoring plan?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
What is the DSMB and what do they do?
DSMB: Data Safety Monitoring Board
Independent group who conducts periodic review and evaluates study data for patient safety, study conduct and progress - will have initiated “event triggers” prior to study start.
Who is responsible for manufacturing, packaging, labeling and coding of the investigational product?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Who is responsible for providing the investigational product only to investigators participating in an investigation?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Who is responsible for maintaining drug and device accountability records from manufacturing through use, return and destruction?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Who is responsible for promptly reporting information about significant new adverse events, new information or risks with respect to the investigational product or investigations to the FDA and investigators?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
If the sponsor determines that the investigational product presents an unreasonable and significant risk to study subjects, the sponsor must do the following (3 things)?
- Discontinue all studies that present the risk
- Notify FDA, all investigators involved in the study(ies) and their IRBs
- Assure return and accounting for all investigational product, its return to the sponsor (or on-site destruction)
Who is responsible to submit Safety Reports (Expedited Reporting), if appropriate?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Who is responsible for providing pre-clinical and clinical study reports in information amendments to the IND/IDE?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Who is responsible for submitting an annual report to the IND/IDE?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Who does the Clinical Investigator include?
- Investigator
- Any sub-investigators
- Spouse of investigator or sub-investigators
- Each dependent child of investigator or sub-investigator
What is Form FDA 3454?
Certification: Financial Interests and Arrangements of Clinical Investigators
What is Form FDA 3455?
Disclosure: Financial Interests and Arrangements of Clinical Investigators
Who is responsible for registering an Applicable Clinical Trial (ACT)?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: a. sponsor
Explanation: A Principle Investigator (PI) can be responsible, however, this needs to be delegated by the sponsor.
Who verifies the rights and well-being of human subjects are protected?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: b. monitor
Who verifies reported trial data is accurate, complete and verifiable from source documents?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: b. monitor
Who verifies the study is conducted in compliance with the study protocol, the GCP guidelines, and applicable regulations?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: b. monitor
Who appoints a monitor for a clinical trial study?
a. sponsor
b. clerical staff
c. investigator
d. IRB
Correct answer: a. sponsor
Who is properly trained and has the scientific and/or clinical knowledge needed to observe the trail adequately?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: b. monitor
Who is the main line of communication between the sponsor and the investigator?
The monitor
Who selects sites and/or processes for targeted for MVs?
The monitor
What does the Statement of Investigator (1572) contain?
- The name and address of the investigational site(s)
- The name and address of the responsible IRB
- The name and address of clinical laboratories, if any
- For devices, the corresponding requirements are contained in an investigator’s agreement (no form comparable to Form FDA 1572)
Who personally conducts or supervises the investigation?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Does the investigator need IRB approval prior to starting any study related activities?
Yes
Who ensures that an IRB complies with requirements of 21 CFR 56 will be responsible for initial and continuing review?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who promptly reports to the IRB all changes in the research activity and unanticipated problems?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who does not may any changes in the research without the sponsor and IRB approval, except to eliminate hazards to human subjects?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who conducts the study in accordance with the relevant, current protocol?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who ensures requirements relating to obtaining informed consent (21 CFR 50) the IRB review and approval (21 CFR 56) are met?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who obtains informed consent from each subject before entry into the study (ex. before any study related procedures)?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who explains the proper use of the investigational product to subjects?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who ensures proper storage and handling of study drug/device; accountability, return or destruction of unused study drug(s)?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who informs subjects that study drugs are being used for investigational purposes?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who ensures investigational product is used only by individuals who have agree to participate in clinical trials as evidenced by signed written informed consent?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who assures the investigational product is used only by the investigator or qualified subinvestigators?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Who assures provisions of medical care be given to study patients for study related adverse events?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Per 21 CFR 312.64, who reports adverse events during the study?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
Per 21 CFR 312.62, who maintains adequate and accurate records and make study records available for inspection?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
How do you correct a mistake per GCP/ALCOA-C?
Single line through the error, enter correct information, initial and date change, provide explanation if needed; do not obliterate the the error, no erasures, no white-out.
How do investigator’s verify the accountability records?
- Doses specified in the protocol were provided to subjects
- Drug/device was provided only to study subjects
- Use by study subjects reconciles the amounts received and returned to the sponsor
- Product was stored as specified by the sponsor and in compliance with applicable regulations
- Device was used for its intended purpose
How often does the investigator needs to provide the IRB/IEC?
Annually or more frequent if required by the IRB/IEC
Who does the final written summary to the IRB/IEC?
a. sponsor
b. monitor
c. investigator
d. IRB
Correct answer: c. investigator
What does “clinical investigators” mean per 21 CFR 54?
Listed or identified investigator or sub-investigator who is directly involved in the treatment or evaluation of research subjects”, including the spouse and each dependent child of the investigator or subinvestigator.
How long is the investigator’s financial disclosure for compensation of >$25,000 or >$50,000 valid for?
a. 7 calendar days
b. 5 days
c. 1 year after completion of the study
d. year
Correct answer: c. 1 year after completion of the study
How long is the investigator’s financial disclosure for compensation of any amount <$25,000 valid for?
a. 7 calendar days
b. 5 days
c. while the study is being conducted
d. year
Correct answer: c. while the study is being conducted
What phase identifies potential new compounds?
a. pre-clinical/non-clinical
b. Phase I
c. Phase II
d. Post Market
Correct answer: a. pre-clinical/non-clinical
What phase tests in appropriate laboratory and animal models to assess potential activity in humans?
a. pre-clinical/non-clinical
b. Phase I
c. Phase II
d. Post Market
Correct answer: a. pre-clinical/non-clinical
What phase involves thousands of molecules?
a. pre-clinical/non-clinical
b. Phase I
c. Phase II
d. Post Market
Correct answer: a. pre-clinical/non-clinical
What phase develops the dosage forms?
a. pre-clinical/non-clinical
b. Phase I
c. Phase II
d. Post Market
Correct answer: a. pre-clinical/non-clinical
What phase includes animal models?
a. pre-clinical/non-clinical
b. Phase I
c. Phase II
d. Post Market
Correct answer: a. pre-clinical/non-clinical
What needs to occur prior to a clinical trial beginning? 3 things.
- summaries of all acute toxicity studies
- 28-day studies in one rodent and one non-rodent species, usually rats and dogs
- regulatory authorities can require more information
- non-clinical studies have to support the conclusion that the drug can be administered safely to human subjects
What phase helps to assure the quality of the scientific evaluation is adequate to permit evaluation of the drug’s safety and effectiveness?
a. pre-clinical/non-clinical
b. Phase I
c. Phase II
d. Post Market
Correct answer: b. Phase II
