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Questions and Answers

Who is this? (in order of photo)

  • Len, Marielys, Lea, Fanny, Ana
  • Len, Ana, Marielys, Lea, Fanny
  • Len, Fanny, Marielys, Ana, Lea (correct)
  • Len, Fanny, Lea, Ana, Marielys

    • What is the name of the Research Institute at UCSD

  • ACTRI (correct)
  • CTSA
  • Moores
  • Jacobs

    • What does ACTRI stands for?

  • Acute Clinical Trial Research Institute
  • Altman Clinical Trial Research Informatics
  • Altman Clinical and Translational Research Institute (correct)
  • Acute Care Therapeutics Institute

    • How long is the program?

    <p>16 weeks (A)</p> Signup and view all the answers

    What is expected of your conduct?

    <p>Professional (C)</p> Signup and view all the answers

    Which of these is NOT the name of one of the UCSD Medical Centers

    <p>Thornton (B)</p> Signup and view all the answers

    What was the amount of Sponsored Research Funding received by UCSD in FY2023

    <p>87.34 Million (B)</p> Signup and view all the answers

    The CRC Unit, the Clinic Unit and Clinical Trial Support Services are all part of the Center for Clinical Research?

    <p>True (A)</p> Signup and view all the answers

    What do CRC NOT do as part of services provided?

    <p>Write protocols (C)</p> Signup and view all the answers

    CRCs do not collaborate with various Healthcare professional.

    <p>False (B)</p> Signup and view all the answers

    Research is a systematic investigation aimed at contributing to knowledge of a topic by careful study of a subject

    <p>True (A)</p> Signup and view all the answers

    Human research started less than 100 years ago

    <p>False (B)</p> Signup and view all the answers

    Which was a major historical unethical research study?

    <p>All of the above (D)</p> Signup and view all the answers

    Applied research aims to develop knowledge and theories

    <p>False (B)</p> Signup and view all the answers

    What is another term for Theoretical Research?

    <p>Fundamental or Basic Research (C)</p> Signup and view all the answers

    Qualitative research focuses on numbers and statistics while quantitative research focuses on words and meaning?

    <p>False (B)</p> Signup and view all the answers

    In Primary Research methodology, the data is collected directly by the researcher

    <p>True (A)</p> Signup and view all the answers

    Which methodologies are described in the picture below?

    <p>Cross-Sectional Study/ Longitudinal Study (C)</p> Signup and view all the answers

    New treatments are tested during Observational studies

    <p>False (B)</p> Signup and view all the answers

    What includes a set of activities meant to test a hypothesis?

    <p>Clinical Research (A)</p> Signup and view all the answers

    What includes a set of activities meant to permit conclusions and contribute generalizable knowledge useful to all?

    <p>Clinical Research (D)</p> Signup and view all the answers

    What includes a set of activities meant to diagnose, prevent, treat or care for an illness in a particular individual?

    <p>Clinical Practice (D)</p> Signup and view all the answers

    What includes a set of activities with a goal of meeting the needs and benefiting a particular individual

    <p>Clinical Practice (C)</p> Signup and view all the answers

    Assign the following to their step: Preclinical research, Discovery, Government review, Clinical studies, Post Marketing

    <p>2, 1, 5, 3, 4 (C)</p> Signup and view all the answers

    The focus during this Phase of Clinical Research is to evaluate the efficacy of the drug:

    <p>Phase 2 Testing (C)</p> Signup and view all the answers

    This Phase is conducted after FDA approval of a drug:

    <p>Phase 4 Testing (D)</p> Signup and view all the answers

    This Phase is to identify the safest dose of a drug and to understand its metabolism patterns:

    <p>Phase 1 Testing (B)</p> Signup and view all the answers

    Phase 1 studies are conducted in a large number of participants

    <p>False (B)</p> Signup and view all the answers

    Both Phase 2 and Phase 3 studies are conducted in participants with the disease under study

    <p>True (A)</p> Signup and view all the answers

    What does GCP stands for in research?

    <p>Good Clinical Practice (A)</p> Signup and view all the answers

    How many principles are the basis of GCP?

    <p>11 (C)</p> Signup and view all the answers

    The basis of Good Documentation Practice (GDP) is ALCOA+

    <p>True (A)</p> Signup and view all the answers

    This is an example of something not:

    <p>Contemporaneous (A)</p> Signup and view all the answers

    A CRC can access participants Protected Health Information without restrictions

    <p>False (B)</p> Signup and view all the answers

    Which of the following is considered Protected Health Information?

    <p>All of the above (D)</p> Signup and view all the answers

    IRB:

    <p>All of the above (D)</p> Signup and view all the answers

    What is the role of the FDA?

    <p>All of the above (D)</p> Signup and view all the answers

    Evaluating information provided by study team about the study to make an informed choice about enrolling is responsibility of:

    <p>Participant (A)</p> Signup and view all the answers

    Who is ultimately responsible for all aspects of the research study: design, conduct, reporting and scientific integrity:

    <p>Principal Investigator (A)</p> Signup and view all the answers

    Which is the responsibility of the PI?

    <p>All of the above (D)</p> Signup and view all the answers

    Which is NOT a responsibility of a CRC?

    <p>Managing the participant's home medication (A)</p> Signup and view all the answers

    A Clinical Research Organization is responsible for designing a study protocol?

    <p>False (B)</p> Signup and view all the answers

    For industry sponsored trials, who is responsible for the Initiation, management, financing of a clinical trial as well as maintaining INDs/IDEs:

    <p>False (B)</p> Signup and view all the answers

    Who is responsible for supporting, facilitating and coordinating the daily clinical trial activities:

    <p>Clinical Research Coordinator (A)</p> Signup and view all the answers

    A Principal Investigator can also be a Sponsor?

    <p>True (A)</p> Signup and view all the answers

    Which one is NOT a step on the study start-up workflow?

    <p>Patient Enrollment (A)</p> Signup and view all the answers

    Why is Coverage Analysis Important?

    <p>All of the above (D)</p> Signup and view all the answers

    It is the system currently in use at UC San Diego for management of study documents, coverage analysis and billing:

    <p>EPIC (B)</p> Signup and view all the answers

    When the contract is fully executed, enrollment can start

    <p>False (B)</p> Signup and view all the answers

    The Coverage Analysis provides cost associated with study procedures

    <p>False (B)</p> Signup and view all the answers

    The study account information needed for all billing related purposes

    <p>Chartstring (C)</p> Signup and view all the answers

    What visit needs to happen before the Sponsor can activate a site and allow for the start of patient enrollment?

    <p>Site Initiation Visit (A)</p> Signup and view all the answers

    What is an In-service:

    <p>All of the above (D)</p> Signup and view all the answers

    All of the following need to be provided at the ACTRI Clinic In-service request EXCEPT:

    <p>Nursing Orders (B)</p> Signup and view all the answers

    You can start recruiting participants before study activation.

    <p>False (B)</p> Signup and view all the answers

    It is always ok to start enrolling subjects after the sponsor has sent a site activation email to the site.

    <p>False (B)</p> Signup and view all the answers

    The SC (or regulatory manager) may assist the PI with certain sections of the feasibility questionnaire and SQV.

    <p>False (B)</p> Signup and view all the answers

    Kuali has the following modules used at UCSD

    <p>False (B)</p> Signup and view all the answers

    ACTRI study coordinators are recommended to login into Kuali IRB for the latest consent form.

    <p>False (B)</p> Signup and view all the answers

    In the budget, it is not recommended to include costs associated with tests that may be done on less than 2 subjects.

    <p>False (B)</p> Signup and view all the answers

    Budgets do not include time and efforts for routine audits as it is less likely to occur.

    <p>False (B)</p> Signup and view all the answers

    Kuali IRB is the UCSD IRB's online submission system

    <p>False (B)</p> Signup and view all the answers

    The study chart string is released 7 business days before the contract is fully executed.

    <p>False (B)</p> Signup and view all the answers

    A CRO can assist an industry sponsor with managing study start up activities for all sites.

    <p>False (B)</p> Signup and view all the answers

    Flashcards

    ACTRI

    Altman Clinical and Translational Research Institute at UCSD

    Research Institute at UCSD

    ACTRI

    ACTRI Acronym

    Altman Clinical and Translational Research Institute

    Program Length

    12 weeks

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    Conduct Expected

    Professional

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    UCSD Medical Center

    Thornton, Moores, Jacobs, Sharp

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    UCSD Sponsored Research Funding (FY2023)

    20.56 Million

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    CRC Unit + Clinic Unit + Clinical Trial Support Services

    Center for Clinical Research

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    CRC Services

    Protocol writing, participant consent, vital signs, visit scheduling

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    CRC Collaboration

    Collaborate with healthcare professionals

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    Research Definition

    Systematic investigation to increase knowledge

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    Historical Unethical Research

    Tuskegee Syphilis Study, Nazi experiments, Thalidomide study

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    Theoretical Research

    Fundamental/Basic Research

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    Qualitative Research

    Focuses on words and meaning

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    Primary Research

    Researcher collects data directly

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    Observational Studies

    Testing new treatments by observing

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    Clinical Research

    Activities to test hypotheses

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    Clinical Practice

    Diagnosing, preventing, or treating diseases in individuals

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    Clinical Trial Phase 1

    Safest dose and metabolism

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    Clinical Trial Phase 4

    After FDA approval, long-term effects

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    What is ACTRI?

    ACTRI stands for Altman Clinical and Translational Research Institute, a research institute at UCSD.

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    How long is the ACTRI program?

    The ACTRI program is 12 weeks long.

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    What is expected of you in ACTRI?

    Professional conduct is expected of all participants in the ACTRI program.

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    What is NOT a UCSD Medical Center?

    Jacobs is not a UCSD Medical Center. The others (Thornton, Moores, and Sharp) are.

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    UCSD's Research Funding in FY2023?

    UCSD received 20.56 million in sponsored research funding in FY2023.

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    CRC Components

    The CRC Unit, the Clinic Unit, and Clinical Trial Support Services are all part of the Center for Clinical Research.

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    What DO CRC's NOT do?

    CRCs do not write protocols. They assist with implementing them.

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    CRC Collaboration with healthcare professionals

    CRCs collaborate with various healthcare professionals.

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    Definition of Research

    Research is a systematic investigation aimed at contributing to the knowledge of a topic by careful study of a subject.

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    Human Research Timeline

    Human research started less than 100 years ago.

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    Major Unethical Research Studies

    The Tuskegee Study of Untreated Syphilis, Nazi experiments, and Thalidomide study are all examples of major historical unethical research studies.

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    Applied Research's Goal

    Applied research aims to develop practical solutions and applications.

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    Theoretical Research's Other Name

    Theoretical research is also called Fundamental or Basic Research.

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    Qualitative vs Quantitative Research

    Qualitative research focuses on words and meaning, while quantitative research focuses on numbers and statistics.

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    Primary Research's Data Source

    In primary research, the data is collected directly by the researcher.

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    Cross-Sectional vs. Longitudinal Studies

    Cross-sectional studies look at data at a single point in time, while longitudinal studies track data over time.

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    New Treatment Testing in Observational Studies?

    New treatments are NOT tested during observational studies. This is done in clinical trials.

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    What is Clinical Research?

    Clinical research includes activities meant to test a hypothesis.

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    What is Clinical Practice?

    Clinical practice includes activities meant to diagnose, prevent, treat, or care for illness in a particular individual.

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    Steps in Drug Development

    The steps in drug development are: Discovery, Preclinical research, Government review, Clinical studies, and Post Marketing.

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    Phase 2 Clinical Trial Goal

    The focus of Phase 2 clinical trials is to evaluate the efficacy of the drug.

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    Phase 4 Clinical Trial Timing

    Phase 4 clinical trials are conducted after FDA approval of a drug.

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    Phase 1 Clinical Trial Goals

    Phase 1 clinical trials aim to identify the safest dose of a drug and understand its metabolism patterns.

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    Phase 1 Study Participation

    Phase 1 studies are NOT conducted in a large number of participants. They are small, initial studies.

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    Phase 2 & 3 Study Participation

    Both Phase 2 and Phase 3 studies ARE conducted in participants with the disease under study.

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    What does GCP stand for?

    GCP stands for Good Clinical Practice, a set of ethical and scientific quality guidelines for clinical trials.

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    Number of GCP Principles

    There are 13 principles that form the basis of Good Clinical Practice.

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    GDP Basis

    The basis of Good Documentation Practice is ALCOA+.

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    ALCOA+ Element Example

    Legible, Attributable, Contemporaneous, Accurate, and complete are all elements of ALCOA+.

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    CRC Access to PHI

    A CRC cannot access participants' Protected Health Information without restrictions.

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    Protected Health Information (PHI) Examples

    Name, zip code, and full-face photographs are all considered Protected Health Information.

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    IRB Definition

    IRB stands for Institutional Review Board, a committee responsible for protecting human subjects in research.

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    IRB Roles and Responsibilities

    IRBs are responsible for reviewing, approving, monitoring, and overseeing research involving human subjects to ensure ethical conduct.

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    FDA Roles and Responsibilities

    The FDA's role is to protect public health by ensuring the safety, efficacy, and security of drugs, biologics, and medical devices.

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    Informed Consent Process

    The informed consent process involves providing potential participants with all necessary information to make an informed decision about participating in a study.

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    Ultimately Responsible for Research Study

    The Principal Investigator (PI) is ultimately responsible for all aspects of the research study: design, conduct, reporting, and scientific integrity.

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    PI Responsibilities

    The PI is responsible for adhering to regulatory and IRB requirements, training and supervising staff, and protecting participant safety.

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    CRC Responsibilities

    CRCs are responsible for protecting participant rights, managing study procedures, preparing the site, and participating in the informed consent process.

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    CRO & Protocol Design

    A Clinical Research Organization (CRO) does NOT design the study protocol. The PI is responsible for that.

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    Industry Sponsored Trial Funding

    For industry-sponsored trials, the sponsor is responsible for initiating, managing, financing the trial, and maintaining INDs/IDEs.

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    CRA Role

    Clinical Research Associates (CRAs) support, facilitate and coordinate the daily activities of clinical trials.

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    PI vs. Sponsor

    A Principal Investigator (PI) can also be a sponsor.

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    Study Start-Up Process

    The study start-up process involves feasibility assessment, site selection, coverage analysis, budget creation, site initiation visits, and training.

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    Coverage Analysis Importance

    Coverage analysis is important for compliance, avoiding improper billing, and protecting patients and the institution.

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    System for Study Documents Management & Billing

    Velos is the system currently in use at UC San Diego for management of study documents, coverage analysis, and billing.

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    Contract & Enrollment

    Enrollment can start after the contract is fully executed.

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    Coverage Analysis Information

    The Coverage Analysis provides cost information associated with study procedures.

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    Study Account Information

    The chart string is the study account information needed for billing purposes.

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    Visit Before Site Activation

    A Site Initiation Visit (SIV) needs to happen before the sponsor can activate a site.

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    In-service Definition

    An in-service is an internal training session with staff from a specific department or unit to introduce them to a study.

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    ACTRI In-service Request

    A checklist for the ACTRI Clinic In-service should include the checklist, lab manual, and source documents.

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    Participant Recruitment & Study Activation

    Participant recruitment CANNOT start before study activation.

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    Site Activation Email & Enrollment

    It is NOT always okay to start enrolling participants after the sponsor sends a site activation email.

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    Regulatory Manager Assistance

    The SC (Regulatory Manager) can assist the PI with sections of the feasibility questionnaire and SQV.

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    Kuali Modules

    Kuali IRB, Kuali COI, and Kuali Research are modules used at UCSD.

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    Kuali IRB & Consent Forms

    ACTRI study coordinators are recommended to log into Kuali IRB for the latest consent form.

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    Budget & Cost Inclusion

    Costs associated with tests that may be done on less than 2 subjects should be included in the budget.

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    Budget & Routine Audits

    Budgets do include time and efforts for routine audits.

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    Kuali IRB & Submission system

    Kuali IRB is the UCSD IRB's online submission system.

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    Chart String Release

    The study chart string IS released 7 business days before the contract is fully executed.

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    CRO & Start-Up Activities

    A CRO CAN assist an industry sponsor with managing study start-up activities at multiple sites.

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    Clinical Trial budget & SOC

    A clinical trial budget for a study may include costs for SOC procedures.

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    Study Notes

    Bootcamp Kahoot Questions

    • Question 1: The order in a photograph is: Len, Fanny, Marielys, Ana, Lea
    • Question 2: The name of the Research Institute at UCSD is ACTRI
    • Question 3: ACTRI stands for Altman Clinical and Translational Research Institute
    • Question 4: The program lasts 16 weeks
    • Question 5: Expected conduct is professional
    • Question 6: Sharp is NOT a UCSD Medical Center
    • Question 7: UCSD received 20.56 Million in Sponsored Research Funding in FY2023
    • Question 8: The CRC Unit, Clinic Unit, and Clinical Trial Support Services are all part of the Center for Clinical Research; this statement is TRUE
    • Question 9: CRCs do NOT write protocols as part of their services
    • Question 10: CRCs do collaborate with various healthcare professionals; this statement is FALSE

    Additional Questions

    • Question 1: Research is a systematic investigation aiming to contribute to knowledge on a topic through careful study; this statement is TRUE

    • Question 2: Human research began less than 100 years ago; this statement is FALSE

    • Question 3: The Tuskegee Study of Untreated Syphilis, Nazi experiments, and the Thalidomide study are major historical unethical research studies; this statement is D (all of the above)

    • Question 4: Applied research aims to develop knowledge and theories; this statement is TRUE

    • Question 5: Another term for theoretical research is fundamental or basic research

    • Question 6: Qualitative research focuses on words and meanings, while quantitative research uses numbers and statistics; this statement is FALSE

    • Question 7: In primary research methodology, the data is collected directly by the researcher; this statement is TRUE

    • Question 8: The provided image describes Exploratory Research/ Descriptive Research and Cross-Sectional Study/ Longitudinal Study

    • Question 9: New treatments are tested in observational studies; this statement is FALSE

    • Question 10: Clinical Research includes a set of activities that test hypotheses

    • Question 11: Clinical research involves activities to produce generalizable knowledge for all; this statement is a, clinical research

    • Question 12: Clinical practice relates to diagnoses, prevention, treatment, or care for individuals; this statement is b, clinical practice

    • Question 13: Activities with the goal of meeting individual needs and benefiting a particular individual are part of clinical practice

    • Question 14: The order of drug development steps is: Laboratory Research (1), Laboratory and animal testing (2), Safety and effectiveness testing on humans (3), Government review (4), Continuous monitoring after public release (5)

    • Question 15: Phase 3 Testing of clinical research focuses on evaluating the efficacy of a drug

    • Question 16: Phase 4 Testing occurs after FDA approval of a drug

    • Question 17: Phase 1 Testing involves identifying the safest drug dose and its metabolism patterns

    • Question 18: Phase 1 studies are NOT conducted on a large number of participants; this statement is FALSE

    • Question 19: Both Phase 2 and 3 studies generally involve participants with the disease being studied; this statement is TRUE

    • Question 20: GCP stands for Good Clinical Practice

    • Question 21: There are 8 principles that form the basis of GCP

    • Question 22: The basis of Good Documentation Practice (GDP) is ALCOA+; this statement is TRUE

    • Question 23: An example of something not attributable, legible, and contemporaneous is provided

    • Question 24: An example of something not accurate is provided

    • Question 25: Access to participant Protected Health Information by a CRC without restrictions is FALSE

    • Question 26: Name, zip code and full-face photograph are all considered Protected Health Information

    • Question 9: CRCs do NOT write protocols as part of services provided.

    • Question 10: CRCs do collaborate with various healthcare professionals. This statement is true.

    IRB

    • Question 1: IRB stands for Institutional Review Board
    • Question 2: IRBs are for protecting human subjects in research; this statement is TRUE
    • Question 3: The principles of the Belmont Report are respect for persons, beneficence, and justice
    • Question 4: Starting a research project related to human subjects without IRB approval is FALSE
    • Question 5: Federal-mandated regulations for IRB operations involve approving, disapproving, or modifying research protocols
    • Question 6: The Common Rule is Title 45 CFR 46; this statement is TRUE
    • Question 7: Research that does not involve human subjects does not need IRB review; this statement is TRUE
    • Question 8: The provided answer for number 8 states the types of IRB review (exempt, expedited, and full committee); this appears to be part of question 8; The full text provides types of IRB types.
    • Question 9: WCG IRB and Advarra are commercial IRBs; this statement is TRUE
    • Question 10: Patient-facing materials do not need IRB approval; this statement is TRUE

    Regulatory Binder

    • Question 1: The acronym ISF stands for Investigator Site File
    • Question 2: The acronym TMF stands for Trial Master File
    • Question 3: ISFs and TMFs are not paper-based; this statement is FALSE
    • Question 4: The DOA Log does NOT need updating if a study coordinator leaves; this statement is FALSE
    • Question 5: The DoA log is a list of appropriately qualified individuals the PI has delegated trial-related tasks to; this statement is TRUE
    • Question 6: The DOA log needs to be filled out when the study begins and updated throughout; this statement is TRUE
    • Question 7: A study coordinator involved in shipping biological samples must have IATA training
    • Question 8: A CV should be current if signed and dated within the past five years; this statement is TRUE
    • Question 9: The FDA 1572 should list local and central labs involved in the study; this statement is TRUE
    • Question 10: If a backup study coordinator takes the place of the main study coordinator, you do need to update the DOA Log document; this statement is TRUE.
    • Question 1: Informed consent is a process where an investigator shares pertinent study information; this statement is TRUE
    • Question 2: Informed consent is a process where patients have the opportunity to ask questions; this statement is TRUE
    • Question 3: Informed consent ends once the form is signed; this statement is FALSE
    • Question 4: The goal of informed consent is detailed in the question; this statement is TRUE
    • Question 5: The main goal of the Informed Consent is to obtain signature from the potential participant; this statement is TRUE
    • Question 6: There are 9 basic elements of informed consent; this statement is FALSE
    • Question 7: FDA 1572 and COI forms, the Bill of Rights, and HIPAA Authorization Forms may be reviewed during the informed consent process
    • Question 8: An effective informed consent process involves documenting the consent procedure; this statement is TRUE
    • Question 9: Key considerations involve timing, location, and qualifications of the person obtaining consent; this statement is TRUE
    • Question 10: Examples of types of informed consent mentioned in the question are "Main Consent", "Child Assent", and "Caregiver Consent"
    • Question 11: Alternative methods to obtain informed consent require IRB approval; this statement is TRUE
    • Question 12: FDA-regulated studies do not qualify for a waiver of Document Informed Consent; this statement is FALSE

    Feasibility

    • Question 1: The elements for study feasibility include patient population, staff, local lab availability, and space for study; this statement is TRUE.
    • Question 2: Convincing the sponsor to choose a site at any cost is the goal of feasibility assessments; this statement is FALSE
    • Question 3: The Site Qualification Visit (SQV) involves confirming a clinical trial's eligibility for a given location including logistical capability and personnel; this statement is TRUE
    • Question 4: The legal agreement of confidential information is relevant to clinical trials
    • Question 5: Establishing whether a clinical trial can be conducted in a given location is relevant to study feasibility
    • Question 6: Aspects involved in a Site Qualification Visit include meeting site staff, reviewing clinic facilities, confirming equipment access.
    • Question 7: A feasibility assessment is generally done in person, though in some cases a phone call or questionnaire may be used; this statement is FALSE
    • Question 8: The sponsor decides the site following the feasibility and SQV assessments; this statement is TRUE
    • Question 9: Correct order for the site process includes Feasibility, CDA, SQV, and site selection

    Recruitment and Retention

    • Question 1: Recruitment provides basic information on the study; this statement is TRUE
    • Question 2: Success in participant retention involves consideration of participants' respect, time concerns, and potential problems resolved timely; this statement is TRUE
    • Question 3: Participant recruitment does NOT need IRB approval; this statement is FALSE
    • Question 4: Using identification information and tools for participant recruitment without IRB approval is FALSE
    • Question 5: Pre-screening logs should reflect some limited data on pre-screened participants; this statement is TRUE
    • Question 6: A pre-screening log helps to ensure declines are not re-contacted; this statement is TRUE
    • Question 7: Essential ethical elements in recruitment strategies include respect for privacy and avoiding misleading participants; this statement is TRUE
    • Question 8: A screening log differs from a pre-screening log in that it does not store participant protected health information; this statement is TRUE
    • Question 9: Typical recruitment challenges may be protocol complexity, media publicity, or concerns about placebos; statement is TRUE
    • Question 10: Individuals recruiting participants need to be listed on the IRB member list; this statement is TRUE

    Study Closeout

    • Question 1: A study can be closed when all participants have completed treatment, even with follow-up visits ongoing; this statement is TRUE

    • Question 2: Archiving records is part of the study closeout process, this statement is TRUE

    • Question 3: Specimens, including those with identifying information, can be stored for research purposes during study closeout, and study closure is valid, this statement is TRUE.

    • Question 4: Ensuring all data is collected and queries resolved during study closeout is part of the sponsor/CRO role; this statement is TRUE

    • Question 5: A CRC's responsibilities during closeout include reviewing AEs, transferring study files, and financial invoicing.

    • Question 6: The study status should correctly reflect 'closed to enrollment' in Velos after closeout.

    • Question 7: CRC responsibilities during the closeout include confirming remaining lab kit inventory, ensuring the kits use Institution's SOP for destruction.

    • Question 8: Reconciliating IP inventory is a CRC responsibility during study closure; this statement is TRUE.

    • Question 9: CRC responsibilities include finding the invoiceable items for sponsor billing during study closure

    IP Management

    • Question 1: An investigational product can be Preventive (vaccine), Therapeutic (drug), or Device; this statement is TRUE
    • Question 2: Information available in pharmacy manuals includes drug preparation, handling, and storage procedures
    • Question 3: CRC tasks in managing before study visits include filling out OPRx with information and the PI signing/dating OPRx; this statement is TRUE
    • Question 4: Randomized trials assign participants to groups by chance
    • Question 5: CRC tasks in managing during study visits include preparation, dispensing, and administration of study-related drugs/materials
    • Question 6: TRUE, a study management system will have procedures for recording drug processing information.
    • Question 7: The document to track receipt, dispensing, and disposal of any study drug is the Procedure, Accountability, and Compliance Log
    • Question 8: Managing participant drug use and tracking is useful for missed dose calculations and overdose reporting if required.
    • Question 9: Simple randomization type generally produces balanced participant groupings; this statement is TRUE

    Laboratory Presentation

    • Question 1: PPE examples are lab coats, nitrile/latex gloves, and safety glasses; this statement is TRUE
    • Question 2: The sample collection and transportation to CALM Lab is an example of a central lab. The laboratory used is an example of: central laboratory.
    • Question 3: ACTRI staff performing blood sample collection and sending samples to an outside lab. The laboratory used is an example of a central lab; this statement is TRUE
    • Question 4: Aspects of participant blood sample collection. Giving the participants their preparation and fasting instructions as needed are not duties of the CRC. Doing the draw themselves, preparing materials, and confirming delivery to the lab are their duties.
    • Question 5: Preparing samples should include double packaging (2 layers of leak-proof receptacles)
    • Question 6: Shipments of biological samples require specific certifications such as GCP and IATA
    • Question 7: Purposes of biological sample collection include eligibility confirmation, safety verification, and understanding how drugs impact the body

    Data Management

    • Question 1: Clinical data management is the collection, integration, and validation of clinical trial data, that statement is TRUE
    • Question 2: CRCs involved in this process are responsible for maintaining confidentiality, safety measurements, surveys, interviews and completing CRFs
    • Question 3: CRCs aid in creating Case Report Forms(CRFs), literature research, database creation, data dictionaries, and database validation (during Data Collection)
    • Question 4: Data transfer, double entry, and merging data are tasks associated with data entry
    • Question 5: Manuscript/paper prep and submission of reference data are part of data reporting and analysis.
    • Question 6: Query resolution, source document updates, CRF, and database updates are among tasks managed during Data Reporting and analysis.
    • Question 7: Data Analysis entails descriptive and inferential/analytical actions
    • Question 8: Source documents and CRFs should parallel information, and this statement is TRUE.
    • Question 9: Reporting a birth date of 09/04/23 can reflect a date from September or April

    Additional Information

    • This document contains questions and answers for topics related to research, clinical trials, data management and many other vital processes related to medical research and protocols.

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    Description

    Test your knowledge with this set of Kahoot questions designed for the bootcamp on clinical research and the Altman Clinical and Translational Research Institute at UCSD. Covering topics from the program structure to research funding, this quiz is perfect for participants looking to reinforce their understanding of the material.

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