Kahoot Questions (2) PDF

Bootcamp Kahoot Questions ACTRI Introduction 1. Who is this? (in order of photo) a. Len, Fanny, Marielys, Ana, Lea b. Len, Ana, Marielys, Lea, Fanny c. Len, Fanny, Lea, Ana, Marielys d. Len, Marielys, Lea, Fanny, Ana 2. What is the name of the Research Insti...

Bootcamp Kahoot Questions ACTRI Introduction 1. Who is this? (in order of photo) a. Len, Fanny, Marielys, Ana, Lea b. Len, Ana, Marielys, Lea, Fanny c. Len, Fanny, Lea, Ana, Marielys d. Len, Marielys, Lea, Fanny, Ana 2. What is the name of the Research Institute at UCSD a. CTSA b. Jacobs c. Moores d. ACTRI 3. What does ACTRI stands for? a. Acute Clinical Trial Research Institute b. Altman Clinical Trial Research Informatics c. Acute Care Therapeutics Institute d. Altman Clinical and Translational Research Institute 4. How long is the program? a. 9 weeks b. 12 weeks c. 16 weeks d. 20 weeks 5. What is expected of your conduct? a. Casual b. Student-like c. Professional d. None of the above 6. Which of these is NOT the name of one of the UCSD Medical Centers a. Thornton b. Moores c. Sharp d. Jacobs 7. What was the amount of Sponsored Research Funding received by UCSD in FY2023 a. 0.87 Million b. 1.76 Million c. 20.56 Million d. 87.34 Million 8. The CRC Unit, the Clinic Unit and Clinical Trial Support Services are all part of the Center for Clinical Research? a. True b. False 9. What do CRC NOT do as part of services provided? a. Write protocols  b. Consent participants c. Obtain vital signs d. Schedule visits 10. CRCs do not collaborate with various Healthcare professional. a. True b. False  What is research? 1. Research is a systematic investigation aimed at contributing to knowledge of a topic by careful study of a subject a. True b. False 2. Human research started less than 100 years ago a. True b. False 3. Which was a major historical unethical research study? a. Tuskegee Study of Untreated Syphilis b. Nazi experiments c. Thalidomide study d. All of the above 4. Applied research aims to develop knowledge and theories a. True b. False 5. What is another term for Theoretical Research? a. Fundamental or Basic Research b. Applied Research c. Artificial Research d. Hypothetical Research 6. Qualitative research focuses on numbers and statistics while quantitative research focuses on words and meaning? a. True b. False 7. In Primary Research methodology, the data is collected directly by the researcher a. True b. False 8. Which methodologies are described in the picture below? a. Exploratory Research/ Descriptive Research b. Cross-Sectional Study/ Longitudinal Study c. Inductive Research/ Deductive Research d. Primary Research/ Secondary Research 9. New treatments are tested during Observational studies a. True b. False 10. What includes a set of activities meant to test a hypothesis? a. Clinical Research b. Clinical Practice  c. Clinical Visit d. Practical Visit 11. What includes a set of activities meant to permit conclusions and contribute generalizable knowledge useful to all? a. Clinical Research b. Clinical Practice c. Clinical Visit d. Practical Visit 12. What includes a set of activities meant to diagnose, prevent, treat or care for an illness in a particular individual? a. Clinical Research b. Clinical Practice c. Clinical Visit d. Practical Visit 13. What includes a set of activities with a goal of meeting the needs and benefiting a particular individual a. Clinical Research b. Clinical Practice c. Clinical Visit d. Practical Visit 14. Assign the following to their step: Preclinical research, Discovery, Government review, Clinical studies, Post Marketing a. 1, 2, 3, 4, 5 b. 3, 1, 5, 2, 4 c. 2, 1, 4, 3, 5 d. 2, 1, 5, 3, 4 15. The focus during this Phase of Clinical Research is to evaluate the efficacy of the drug: a. Phase 1 Testing b. Phase 2 Testing c. Phase 3 Testing d. Phase 4 Testing 16. This Phase is conducted after FDA approval of a drug: a. Phase 1 Testing b. Phase 2 Testing  c. Phase 3 Testing d. Phase 4 Testing 17. This Phase is to identify the safest dose of a drug and to understand its metabolism patterns: a. Phase 1 Testing b. Phase 2 Testing c. Phase 3 Testing d. Phase 4 Testing 18. Phase 1 studies are conducted in a large number of participants a. True b. False 19. Both Phase 2 and Phase 3 studies are conducted in participants with the disease under study a. True b. False 20. What does GCP stands for in research? a. Global Coffee Platform b. Google Cloud Platform c. Good Clinical Practice d. Good Colleague Procedure 21. How many principles are the basis of GCP? a. 8 b. 11 c. 13 d. 18 22. The basis of Good Documentation Practice (GDP) is ALCOA+ a. True b. False 23. This is an example of something not: a. Attributable b. Legible c. Contemporaneous d. Accurate 24. This is an example of something not:  a. Attributable b. Legible c. Both Legible and Attributable d. Accurate 25. A CRC can access participants Protected Health Information without restrictions a. True b. False 26. Which of the following is considered Protected Health Information? a. Name b. Zipcode c. Full face photograph d. All of the above  Responsibilities of the Investigator and CRC 1. IRB: a. Stands for Interventional Review Board b. Also called Ethics Committee c. Comprised of 3 persons, including one member not affiliated with the institution. d. All of the above 2. What is the role of the FDA? a. Protecting the public health b. Ensuring the safety, efficacy and security of drugs, biologics and devices c. Ensuring clinical trials are conducted according to federal law and GCP d. All of the above 3. Evaluating information provided by study team about the study to make an informed choice about enrolling is responsibility of: a. Sponsor b. Principal Investigator c. Clinical Research Coordinator d. Participant 4. Who is ultimately responsible for all aspects of the research study: design, conduct, reporting and scientific integrity: a. Sponsor b. Principal Investigator c. Clinical Research Coordinator d. Clinical Research Organization 5. Which is the responsibility of the PI? a. Adherence to regulatory and IRB requirements and guidance b. Training and supervision of collaborating faculty and staff c. Protecting the safety and welfare of the research participants d. All of the above 6. Which is NOT a responsibility of a CRC? a. Protecting the rights and welfare of human subjects b. Managing the participant's home medication c. Preparing the site for study conduct d. Participating in the Informed Consent Process 7. A Clinical Research Organization is responsible for designing a study protocol? a. True b. False 8. For industry sponsored trials, who is responsible for the Initiation, management, financing of a clinical trial as well as maintaining INDs/IDEs: a. Sponsor b. Principal Investigator c. Clinical Research Coordinator d. Participant 9. Who is responsible for supporting, facilitating and coordinating the daily clinical trial activities: a. Sponsor b. Principal Investigator c. Clinical Research Coordinator d. Clinical Research Associate 10. A Principal Investigator can also be a Sponsor? a. True b. False  Start-Up Process: 1. Which one is NOT a step on the study start-up workflow? a. Study Feasibility and Site Selection b. Coverage Analysis and Budget creation c. Patient Enrollment d. Site Initiation Visit and In-services 2. Why is Coverage Analysis Important? a. Compliance b. Avoid improper billing c. Protect our patients and our institution d. All of the above 3. It is the system currently in use at UC San Diego for management of study documents, coverage analysis and billing: a. EPIC b. Velos c. Clinical Conductor d. Concur 4. When the contract is fully executed, enrollment can start a. True b. False 5. The Coverage Analysis provides cost associated with study procedures a. True b. False 6. The study account information needed for all billing related purposes a. Chartstring a. IRB number b. Kuali Record number c. Index number 7. What visit needs to happen before the Sponsor can activate a site and allow for the start of patient enrollment? a. Site Qualification Visit b. Site Initiation Visit c. Interim Monitoring Visit d. Site Closeout Visit 8. What is an In-service: a. Is an internal training session with the staff from a specific UCSD department or unit. b. Is done to introduce UCSD Healthcare workers to your study and inform them that research procedures will be performed in their unit. c. Can be in-person or on Zoom d. All of the above 9. All of the following need to be provided at the ACTRI Clinic In-service request EXCEPT: a. In-service Checklist b. Study Lab Manual c. Study Source Documents  d. Nursing Orders 10. You can start recruiting participants before study activation. a. True b. False 11. It is always ok to start enrolling subjects after the sponsor has sent a site activation email to the site. a. True b. False 12. The SC (or regulatory manager) may assist the PI with certain sections of the feasibility questionnaire and SQV. a. True b. False 13. Kuali has the following modules used at UCSD a. Kuali IRB, Kuali COI, Kuali Research b. Kuali IRB, Kuali Research, Kuali Data c. Kuali Data, Kuali COI, Kuali Velos d. Kuali Velos, Kuali Research, Kuali Data 14. ACTRI study coordinators are recommended to login into Kuali IRB for the latest consent form. a. True b. False 15. In the budget, it is not recommended to include costs associated with tests that may be done on less than 2 subjects. a. True b. False 16. Budgets do not include time and efforts for routine audits as it is less likely to occur. a. True b. False 17. Kuali IRB is the UCSD IRB's online submission system a. True b. False 18. The study chart string is released 7 business days before the contract is fully executed. a. True b. False 19. A CRO can assist an industry sponsor with managing study start up activities for all sites. a. True b. False 20. A clinical trial budget for a study may include costs for SOC procedures. a. True b. False  Protocol/MOP/SOP: 1. You can find all the necessary information for the conduct of the study in this document: a. Informed Consent Form b. Pharmacy Manual c. Protocol/Research Plan d. None of the above 2. Your PI wants to check the dose of the IP, where do you check to find this information? a. Informed Consent Form b. Protocol c. Manual of Operations and Procedures (MOP) d. Standard Operating procedure (SOP) 3. Some of the essential elements in a protocol are a. Study Design b. Schedule of Events c. Study Assessments and Procedures d. All of the above 4. What is the rule regarding Inclusion Criteria: a. A potential candidate must meet ALL of these to qualify for the study b. A potential candidate must meet NONE of these to qualify for the study c. A potential candidate can meet SOME of these to qualify for the study d. This criteria is only a suggestion for what participants should have to be included in the study but doesn’t need to be followed. 5. What is the rule regarding Exclusion Criteria: a. A potential candidate must meet ALL of these to qualify for the study b. A potential candidate must meet NONE of these to qualify for the study c. A potential candidate can meet SOME of these to qualify for the study d. This criteria is only a suggestion for what participants should have to be excluded from the study but doesn’t need to be followed. 6. TRUE or FALSE: Every protocol amendment has to receive regulatory approval before any changes can be implemented. a. True b. FALSE 7. A Manual of Operations and Procedures (MOP) is : a. A document with detailed information on the study’s conduct and operations b. A description of a process to record routine operations and practices c. A document with all the scientific research information about a study d. All of the above 8. A Standard Operating Procedure (SOP) is: a. A document with detailed information on the study’s conduct and operations b. A description of a process to record routine operations and practices c. A document with all the scientific research information about a study d. All of the above 9. This is an example of :  a. b. MOP c. SOP d. Protocol e. None of the above 10. This is an example of: a. MOP b. SOP c. Protocol d. None of the above  Institutional Review Board (IRB) 1. What does IRB stand for? a. Institutional Research Board b. International Review Board c. Institutional Review Board d. International Research Board 2. IRBs are for the Protection of Human Subjects in Research. a. True b. False 3. The overarching principles of the Belmont Report are: a. Respect for persons; Beneficence; Justice b. Respect for persons; Benefits; Justice c. Regards for persons; Benevolence; Judgement d. Regards for persons; Beneficence; Judgement 4. A research project involving human subjects can be initiated without review by an IRB. a. True b. False 5. Federal regulations indicate IRBs can: a. Approve, disapprove, or require modifications of a protocol b. Conduct continuing reviews of research c. Suspend or terminate approval of research d. All of the above 6. Title 45 CFR 46 is also known as The Common Rule a. True b. False 7. A project does not require an IRB review if it involves research and human subjects. a. True b. False 8. These are all types of IRB Reviews EXCEPT: a. Exempt Review b. Expedited Review c. Full Committee Review d. Half Committee Review 9. WCG IRB and Advarra are Commercial IRBs a. True b. False 10. Patient facing materials does not need IRB approval. a. True b. False  Regulatory binder 1. What does ISF stand for? a. Independent Safety File b. Independent Site File c. Investigator Site File d. Investigator Safety File 2. What does TMF stand for? a. Total Master File b. Total Maintenance File c. Trial Master File d. Trial Maintenance File 3. ISFs and TMFs are always paper based. a. True b. False 4. It is not required to update the DOA Log if the study coordinator leaves the study. a. True b. False 5. The DoA log is a list of appropriately qualified persons to whom the PI has delegated significant trial related duties. a. True b. False 6. The DOA log should be populated when the study starts and updated as needed throughout the study a. True b. False 7. A study coordinator involved in shipping blood collected from subjects must have a. IATA training b. Biomed training c. GCP training d. Nursing degree 8. A CV is considered current if it is signed and dated within past 5 years. a. True b. False 9. The FDA1572 should list local and central labs involved in the study. a. True b. False 10. It is required to update the DOA Log if a backup study coordinator fills in for the main study coordinator for one day. a. True b. False  Informed Consent 1. Informed consent is a process in which the investigator shares all relevant information about the study a. True b. False 2. Informed consent is a process when the potential participant has opportunity to ask questions to decide on participation a. True b. False 3. Informed consent ends once the informed consent form is signed. a. True b. False 4. Goals of Informed Consent include all of the following EXCEPT: a. Protect human subjects/research participants b. Provide details of the study c. Obtain potential participant’s signature ASAP to increase enrollment number d. Stimulate discussion of questions & provide answers and clarifications 5. The main goal of the Informed Consent is to obtain signature from the potential participant a. True b. False 6. There are nine basic elements of the informed consent. a. True b. False 7. Which additional forms are required to be reviewed during the informed consent process? a. FDA 1572 Forms and COI forms b. Bill of Rights (BoR) and HIPAA Authorization Form c. Research protocol and Investigator’s Brochure d. None of the above 8. An effective informed consent process involves documenting the consent appropriately. a. True b. False 9. Key considerations for obtaining informed consent include the following: a. Timing b. Location c. Qualifications of person obtaining consent d. All of the above 10. The following are a Type of Informed Consent in Research EXCEPT: a. Main Consent b. Child Assent c. Commissioner Consent d. Caregiver Consent 11. Alternative methods to obtaining informed consent requires IRB approval. a. True b. False 12. FDA regulated studies do not qualify for a Waiver of Documented Informed Consent.  a. True b. False 13. The following are considered as Vulnerable Populations EXCEPT: a. Cognitively Impaired b. Cancer Patients c. Children d. Pregnant Women & Human Fetal Tissues 14. Research in children must adhere to additional safeguards for protection. These safeguards include: a. Main consent & Prescreening ICF b. Caregiver consent & Adult consent c. Parental permission & Child Assent d. Genetic testing ICF & Adult consent 15. A LAR is an individual authorized to consent on behalf of a prospective subject to their participation in a procedure a. True b. False 16. The preferred method for consenting non-English speakers is to provide consent forms written in the participant’s language. a. True b. False 17. Even if not delegated, anyone from the research team can obtain consent. a. True b. False 18. The following are appropriate consent methods EXCEPT for: a. In-person b. DocuSign (Part 11 Compliant) c. Email with ICF attached d. Remote by phone 19. The potential participant cannot take home the consent form to decide whether to participate. a. True b. False 20. Re-consenting is not necessary when: a. Indicated in the most recent IRB approval b. PI change c. Protocol amendment to the study but does not change the risk and benefit to subject d. New risks are identified 21. If you are not sure how to respond to a question when consenting a potential participant, think quickly and come up with an appropriate response. a. True b. False  Feasibility 1. Which of the following is NOT assess during study feasibility? a. Patient Population b. Staff availability and credentials c. Cost of local laboratory tests d. Space to conduct the trial 2. The goal of the feasibility assessment is to convince the Sponsor to select the site at all cost a. True b. False 3. Which of the following is true for the Site Qualification Visit (SQV)? a. Legal agreement that governs the disclosure of confidential information as related to the clinical trial b. A meeting with sponsor to ensure PI is fully capable/equipped to run a study c. Evaluates the possibility of conducting a clinical trial in a proposed location d. Last step before the Sponsor can activate a site and allow for the start of patient enrollment 4. Which of the following is true for a Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA)? a. Legal agreement that governs the disclosure of confidential information as related to the clinical trial b. A meeting with a sponsor to ensure the institution is fully capable and equipped to run a specific clinical trial c. Evaluates the possibility of conducting a clinical trial in a proposed location d. Last step before the Sponsor can activate a site and allow for the start of patient enrollment 5. Which of the following is true for Study feasibility assessment? a. Legal agreement that governs the disclosure of confidential information as related to the clinical trial b. A meeting with a sponsor to ensure the institution is fully capable and equipped to run a specific clinical trial c. Evaluates the option of conducting a clinical trial in a proposed location d. Last step before the Sponsor can activate a site and allow for the start of patient enrollment 6. During the Site Qualification Visit, the monitor will: a. Meet with the PI and staff b. Tour the facilities (Clinic, Lab, Pharmacy, etc.) c. Verify available equipment (Clinic equipment, Lab equipment, etc.) d. All of the above 7. The feasibility assessment is done in-person during the Qualification visit a. True b. False (questionnaire or Phone Call) 8. After the Feasibility assessment and SQV to site, the Sponsor proceeds to make the site selection decision. a. True b. False 9. What is the correct order of the Site selection process? a. Feasibility, CDA, SQV, Site selection  b. Site selection, SQV, feasibility, CDA c. CDA, Feasibility, SQV, Site selection d. Site selection, Feasibility, SQV, CDA 10. The feasibility assessment does not impact the success of patient enrollment in a study a. True b. False  11. Recruitment & Retention 1. Recruitment provides basic information about the study in order to attract interest in participation. a. True b. False 2. A successful participant retention strategy involves: a. Treating the participant with respect b. Being considerate of the participant’s time c. Identifying & overcoming barriers to retention in a timely manner d. All of the above 3. Participant recruitment does not need IRB approval. a. True b. False 4. Patient’s identification and recruitment tool (i.e. ResearchMatch, EMR) can be used without IRB approval a. True b. False 5. Which are true about pre-screening logs? a. GCP guidance requires that the PI document all pre-study recruitment activities b. Pre-screening logs should record limited details of those pre-screened c. A pre-screening log is a helpful tool to ensure those who decline are not re-contacted d. All of the above 6. What IRB approval allows researchers to use/access PHI for recruitment purposes only? a. FDA 1572 b. Partial HIPAA Waiver c. DoA log d. All of the above 7. Respect for privacy, lack of pressure, unbiased presentation of the study, and avoiding therapeutic misconception are ethical concerns & principles when evaluating recruitment strategies. a. True b. False 8. What is the main difference between a pre-screening log and a screening log. a. A screening log does not contain PHI b. A pre-screening log list only participants that were contacted c. A screening log only list participants who consented to the study d. A pre-screening log list only participant that declined study participation 9. Intricacy of study protocol, bad publicity by media, and concerns about getting a placebo are challenges to recruitment. a. True b. False 10. The individual recruiting participants does not need to be listed as a Key Personnel in the IRB. a. True b. False 12. Research Systems: 1. Kuali IRB is best described as: a. Local IRB portal used at UCSD b. Central IRB c. All of the above d. None of the above 2. Which if the below is a Clinical trial Management system (CTMS) that enables the management of research, safety, regulatory, financial, biospecimen, and operational data in one location: a. EPIC b. Velos c. Clinical Conductor d. Concur 3. Electronic Medical record system used at UC San Diego Health a. EPIC b. Velos c. Clinical Conductor d. Concur 4. Which system is used in the ACTRI clinic for scheduling purposes: a. EPIC b. Velos c. Clinical Conductor d. Concur 5. What is REDCAP: a. A Secure web application for building and managing online surveys and databases. b. The system used for billing purposes c. The Electronic Medical Record used at UCSD d. The system used to order gift cards for research participants 6. At UCSD, CRC primarily use it for requesting participants’ compensation (gift cards): a. EPIC b. Velos c. Clinical Conductor d. Concur 7. Florence e-Binders allow study team to have: a. All digital from start-up to close-out b. Remote Monitoring c. Customizable electronic logs d. All of the above 8. Which of the following is NOT one of the forms that need to be completed in Velos before study can be activated? a. Research Account Form b. Research Laboratory Form c. Research Pharmacy Form d. Research Imaging Form 9. TRUE or FALSE: After consenting a participant, CRC needs to upload the signed Consenting Documents to participant’s EPIC chart. a. True b. False 10. TRUE or FALSE: For each participant’s study visit, CRC needs to upload Clinic Nursing orders in Clinical Conductor at least 48 hours prior to the study visit. a. True b. False 13. IP Management: 1. An investigational product in a clinical trial can be: a. Preventative (vaccine) b. Therapeutic (drug or biologic) c. Device d. All of the above 2. Pharmacy manual provides information on: a. Preparation of study drug b. Handling of study drug c. Storage of study drug d. All of the above 3. Which of the following does NOT occur BEFORE a study visit: a. CRC fills out OPRx with Participant and visit information b. PI signs and date OPRx c. CRC shares sign OPRx with IDS d. IDS prepares the study drug 4. True or False: A randomized trial is a design where participants are assigned into different groups by chance to compare treatments a. True b. False 5. Which of the following does NOT occur DURING a study visit: a. CRC shares sign OPRx with IDS b. Study Drug Preparation c. Study Drug Dispensation d. Study Drug Administration 6. TRUE or False: A double-blinded study refers to a study in which both the participants and the Principal Investigator know the type of treatment given to the participant. a. True b. False 7. Shows a complete and accurate record of how the drug or device was received, dispensed, and disposed of, including quantities used and final disposition: a. Procedure Log b. Accountability Log c. Temperature Log d. Compliance Log 8. Used to track study drug disposition and accountability for each individual participant and can be useful in the calculation of missed doses and or overdose: a. Procedure Log b. Accountability Log c. Temperature Log d. Compliance Log 9. TRUE or FALSE: The Simple randomization type is the easiest to implement and provide equal number of participant in each group a. True  b. False 10. TRUE or FALSE: The Block randomization type ensure there is an equal number of participant in each group a. True b. False 14.Laboratory Presentation: 1. Which of the following are examples of Personal Protective Equipment (PPE): a. Laboratory coat b. Nitrile/Latex gloves c. Safety glasses d. All of the above 2. Blood samples were collected at ACTRI clinic and transported to UCSD CALM Lab for processing. The laboratory used is an example of: a. Central Laboratory b. Local Laboratory c. International Laboratory d. None of the above 3. ACTRI staff performed a blood samples collection and then processed, packed and shipped samples to ICON Laboratory for processing. The laboratory used is an example of: a. Central Laboratory b. Local Laboratory c. International Laboratory d. All of the above 4. Which of the following is NOT a role of CRC in participants’ blood sample collection? a. Give participants instructions prior to study visit (ex. Need for fasting). b. Performing the blood draw on participants. c. Preparing lab kits before each study visit and delivering it to ACTRI lab at least 24 hours prior to participant’s visit. d. Confirming package containing the samples was picked-up by courier. 5. You need to ship frozen blood samples to ICON laboratory. Which of the following are needed for this shipment? a. Samples should be packed in 2 layers of Leak-proof receptacles. b. A requisition form must accompany the samples. c. Confirm that the outer box is displaying all the correct labels. d. All of the above 6. Which specific training and certification is required to ship biological samples? a. GCP b. IATA c. HIPAA d. Bloodborne Pathogen 7. Purpose of biological samples collection: a. Eligibility Check: Verify participant meets Inclusion and Exclusion Criteria set per protocol b. Safety Labs: Verify that the study procedures do not have an adverse effect on the study participants c. Investigative Labs: Understand how the drug gets used and processed by the body d. All of the above 8. Where do you find specific information and instructions regarding samples collection, storage and shipping for your study: a. Protocol  b. Informed Consent Form c. Laboratory Manual d. Pharmacy Manual 9. Pharmacokinetics (PK) studies: a. What does the body do to the drug? How the body interacts with administered substances for the entire duration of exposure. b. How does the drug flows through an Infusion pump? c. “What does the drug do to the body?” The drug's molecular, biochemical, and physiologic effects or actions on the body. d. How long the drug is stable for 10. Pharmacodynamics (PD) refer to: a. What does the body do to the drug? How the body interacts with administered substances for the entire duration of exposure. b. How does the drug flows through an Infusion pump? c. “What does the drug do to the body?” The drug's molecular, biochemical, and physiologic effects or actions on the body. d. How long the drug is stable for 11. What is the main advantage for a sponsor to use a local lab? a. Cheaper b. Faster results c. Uniform across sites d. More reliable 12. The main advantage to use a central lab is uniformity across all sites? a. True b. False 13. After centrifugation, the yellow-ish liquid obtained from this tube will be serum? (Purple top) a. True b. False 14. Serum is the liquid portion of blood that has been allowed to clot a. True b. False 15. What types of samples are collected for research? a. Blood b. Urine c. Tissue d. All of the above 15. Data Management 1. Clinical Data Management is the collection, integration and validation of clinical trial data. a. True b. False 2. During this process the CRC helps maintaining confidentiality, monitoring safety measures, administering surveys, conducting interviews, and completing CRFs: a. Data Design b. Data Collection c. Data Entry d. Data Cleaning 3. During this process the CRC helps with identifying source docs, creating Case Report Forms (CRFs), literature searches, building database, writing data dictionary, and database validation: a. Data Design b. Data Collection c. Data Entry d. Data Cleaning 4. During this process the CRC help by transferring data from CRF to database, double entering & merging: a. Data Cleaning b. Data Analysis c. Data Entry d. Data Reporting and Presentation 5. During this Process the CRC assists in preparing manuscript, literature reviews, compiling references, conference paper or poster, PI talks, and ClinicalTrials.gov reporting: a. Data Cleaning b. Data Analysis c. Data Entry d. Data Reporting and Presentation 6. During this process the CRC helps with query generation & resolution, updating source docs, CRFs & database: a. Data Cleaning b. Data Analysis c. Data Entry d. Data Reporting and Presentation 7. During this process the CRC assists in performing descriptive (and perhaps Inferential) analysis: a. Data Cleaning b. Data Analysis c. Data Entry d. Data Reporting and Presentation 8. Source Documents and Case Report Form should mirror each other a. True b. False 9. What is the issue with reporting a date of birth as 09/04/23? a. It could be in September or in April  b. The date could be on the 4th or the 9th of the month c. The year could be 1923 or 2023 d. All of the above 10. Industry-Sponsored mostly use RedCap as their database/eCRF a. True b. False 11. A CRC needs to send the signed study drug prescription order to IDS, what are important considerations? a. Start the email subject line with “Secure:” b. Limit the use of PHI in the subject line c. Use the study ID and/or Initials instead of the full name of participant d. All of the above 12. This is the correct way to rectify an error during data collection a. True b. False 13. Following a visit, data entry in the eCRF can be done up to 2 weeks later a. True b. False 14. In clinical research, what is a query? a. A communication tool used to clarify or resolve any discrepancies or inconsistencies found in the data. b. A fellow researcher prying on the work of their colleagues c. A request for information to be extracted from a database d. A mechanism between Coders and physicians to clarify ambiguous or incomplete documentation in the medical record. 15. When a study is closed, the records and binders can be disposed of a. True b. False 16.Subject Compensation: 1. Compensation refers to anything given to participants as remuneration for the time and inconvenience of participation in research a. True b. False 2. Reimbursement is when the researchers pay some or all of the costs generated by the participants to attend a visit (ie transportation): a. True b. False 3. At UCSD, you use this online system to order gift cards for participants compensation for their study visits: a. Concur b. Velos c. Clinical Conductor d. Epic 4. If a participant makes more than the following amount in one calendar year, it needs to be reported to the IRS: a. $300 b. $600 c. $1,000 d. Always needs to be reported independent of the amount 5. Which kind of Log do you need to keep track of gift card given to participants? a. Screening Log b. Enrollment Log c. Compensation Tracking Log d. Concomitant Procedure Log 6. You should avoid the following when creating a compensation plan: a. Coercion b. Undue influence c. All of the above d. None of the above 7. The following requirements are needed for a compensation plan: a. Subjects participating in the same study and completing the same tasks should be compensated equitable b. Reduce the exposure to risks associated with loss of privacy or breach of confidentiality. c. Should be presented in the same manner as other information in the recruitment and consent materials. d. All of the above 8. True or False: Compensation is considered a benefit? a. True b. FALSE 9. Which is the best document to look for the compensation plan? a. Study Reference Manual b. Informed Consent Form  c. HIPAA d. California Bill of Rights 10. All studies provide parking vouchers to their study participants? a. True b. FALSE 17. Oversight: Monitoring visits, Audits, Inspections 1. Monitoring visits are conducted by a representative of the sponsor/CRO involved with the study? a. True b. False 2. The CRC is closely involved with monitoring visits, audits and inspections along with the investigator and other research team members a. True b. False 3. Oversight of clinical research activities is important to verify that the reported trial data is accurate, complete, and verifiable from source documents a. True b. False 4. It is not required to submit the FDA483 to the IRB of record a. True b. False 5. Who is required to be present at the exit interview for an FDA inspection? a. PI and study coordinator b. IRB representative and study coordinator c. Compliance team and study coordinator d. None of the above 6. What are the 3 main areas of review of an audit or inspection a. Subject binders, facilities for research, handling of IP b. Regulatory binder, subject binders, handling of IP c. Regulatory binder, subject binders, staff interviews d. None of the above 7. At the time of an FDA inspection, the notice of inspection is a. FDA483 b. FDA482 c. FDA481 d. FDA480 8. What type of inspection has quality control function a. Inspection b. Audit c. Monitoring visits d. All of the above 9. Monitoring visits may be conducted every 4-6 weeks depending upon the frequency of subject randomization and visits a. True b. False 10. A ‘for cause’ audit may be conducted by the sponsor/CRO due to: a. High numbers of protocol deviations and participant complaints b. High number of follow up visits and participant complaints c. High numbers of protocol deviations and follow up visits d. None of the above 18. Effective Communication 1. If a participant does not pick up the phone, you can remind them about an upcoming appointment by leaving a voicemail in which you specify the name of the doctor, name of Research study they are participating, participant’s disease diagnosis and upcoming appointment’s information. a. True b. False 2. To save time, you can start the Informed Consent process in the waiting room area and continue the discussion in an Exam Room once it is available: a. True b. False 3. By being mindful of “waiting room” conversations, being careful not to share information without permission, the CRC a. Uphold safety, privacy & confidentiality of their participants b. Ensure the Protocol is being followed c. Develop Positive Relationships d. All of the above 4. By keeping visits on schedule, complete lab tests when scheduled, perform all assessments completely and accurately, the CRC a. Uphold safety, privacy & confidentiality of their participants b. Ensure the Protocol is being followed c. Develop Positive Relationships d. All of the above 5. A CRC can improve Recruitment, retention and compliance outcomes by doing the following: a. Uphold safety, privacy & confidentiality of their participants b. Ensure the Protocol is being followed c. Develop Positive Relationships d. All of the above 6. It is acceptable to connect and communicate with participants via Facebook or Instagram account. a. True b. False 7. To ensure participants complete the study visits and assessments, CRCs have to be firm and inconsiderate a. True b. False 8. A situation arises within your team at work, what is the best course of action a. Fix it yourself and don’t tell anyone b. Talk to your supervisor to keep them informed c. Vent about it with your colleagues d. Report the issue to HR Department 9. What is a good approach when dealing with a conflict resolution a. Drop the defenses b. Own your mistakes/ shortcomings c. Try to understand the other’s perspective d. All of the above 10. It is acceptable to discuss your jobs and/or patients on posts on social media a. True b. False 19. Study closeout 1. A study can be closed with the IRB once all study subjects have completed treatment even though follow up visits are ongoing a. True b. False 2. Records archiving is a part of the study close out process a. True b. False 3. Specimens containing individually identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research continues. Can the study be closed? a. Yes b. No 4. At the study closeout visit, the sponsor/CRO will ensure that all the data have been collected (there are no more outstanding adverse events & all outstanding queries/data clarification forms have been resolved appropriately). a. True b. False 5. Which of the following is not the responsibility of the CRC during Close-out? a. Reviewing AE, SAE and PD for IRB reporting b. Transferring study files back to the PI c. Reviewing enrollment number and invoiceable items for financial invoicing d. Filing final safety reports with the FDA 6. What is the appropriate status of the study in Velos after the study has been closed? a. Study - Active/ Enrolling b. Study - Not Active c. Study - Closed to enrollment d. Study - Permanently closed 7. What does a CRC do with remaining lab kits at the time of study closure a. Confirm inventory of remaining lab kits with Sponsor b. Destroy kits based on institution’s SOP c. Write NTF to document the destruction of lab kits d. All of the above 8. It is the responsibility of the CRC to reconciliate IP inventory at the time of study closure a. True b. False 9. The study is closing, what should the CRC do with the IPad used to administer questionnaires during the study? a. Keep it in the office for future studies b. Take it home, there is no use for it in the study anymore c. Return to the Sponsor with the rest of the study specific equipment d. None of the above 10. Where does a CRC find the invoiceable items and everything that should be invoiced to Sponsor at the end of study? a. Coverage Analysis b. Budget c. Informed Consent Form d. Confidentiality Disclosure Agreement 20. Acronyms: 1. SIV: a. Site Involvement Visit b. Site Initiation Visit c. Sponsor Introduction Visit d. None of the above 2. IMV: a. Initial Monitoring Visit b. Interim Monthly Visit c. Internal Monitoring Visit d. Interim Monitoring Visit 3. CRA: a. Clinical Research Associate b. Coordinator Research Associate c. Clinical Research Administration d. None of the above 4. CRC: a. Clinical Research Candidate b. Clinical Response Coordinator c. Clinical Research Coordinator d. None of the above 5. PI: a. Principal Interviewer b. Principal Investigator c. Partial Investigator d. Private Investigator 6. IRB: a. Institutional Review Board b. Interventional Review Board c. Institutional Research Board d. Interventional Research Board 7. IDS: a. Intermittent Device Service b. Investigational Drug Services c. Investigational Drug Supply d. None of the above 8. CRF: a. Case Review Form b. Case Report Form c. Clinical Report Form d. None of the above 9. EDC: a. Electronic Device Coordinator b. Evaluating Data Capture  c. Electronic Data Capture d. Electronic Device Capture 10. IP: a. Independent Product b. Initial Product c. Investigational Product Investigative Product 11. CRO: a. Clinical Research Organization b. Clinical Research Organizer c. Clinical Report Organizer d. None of the above 12. ICF: a. Investigational Consent Form b. Informed Correct Facts c. Informed Consent Facts d. Informed Consent Form 13. GCP: a. Great Clinical Practice b. Good Clinical Practice c. Good Conduct Practice d. None of the above 14. PHI: a. Principal Health Information b. Protected Health Initiative c. Principal Health Initiative d. None of the above 15. AE: a. Accurate Entry b. Approved Examination c. Adverse Event d. Account Executive 16. IRT: a. Initial Response Therapy b. Interactive Response Technology c. Interactive Randomization Tool d. Initial Randomization Technology 17. MRN: a. Material Receiving Note b. Medical record Number c. My Referral Network d. Medicare Remittance Notice 18. DoA a. Dead on Arrival log  b. Date of Arrival log c. Date of Assessment log d. Delegation of Authority log 19. SOE a. Schedule of Events b. State-owned Enterprise c. Standard Option Equipment d. School of Education 20. SAE a. Severe Adverse Event b. Simple Adverse Event c. Strong Adverse Event d. Serious Adverse Event IRB Safety Reporting 1. Whom would you report a serious adverse event to? a. Sponsor, HR b. DSMB, HR c. DSMB, Supervisor d. Sponsor, DSMB 2. Lightheadedness following a blood draw is an example of an AE. a. True b. False 3. It is ok to disregard an adverse event related to administration of IP if it is not listed in the consent form. a. True b. False 4. A study coordinator missed a lab to check for liver health following administration of IP. It is ok to not document this as long as this mistake is not repeated. (Sentence too long. Changed to: “A CRC missed a lab test required at a study visit. It’s ok not to document this as long as the mistake is not repeated” a. True b. False 5. An event is considered an AE if the severity of an existing symptom changes after administration of IP a. True b. False 6. Minor protocol violations include instances that do not impact participant safety or substantially alter risks to participants a. True b. False 7. A subject complaint not resolved by the research team may need to be reported to the IRB a. True b. False 8. Adverse events can occur both pre- and post-marketing approval. a. True b. False 9. Investigators are responsible for the accurate documentation, causality assessment and follow-up of all definite, probable and possible study related AEs and safety-related information. (Sentence too long. Changed to: “Investigators are responsible for accurate documentation, causality assessment, and follow-up of study related AEs”) a. True b. False 10. Following a safety report to the IRB, the following may happen a. Request additional information b. Flag the report and monitor the study c. Permanently suspend or terminate approval d. All of the above