Clinical Research Associate (CRA) - Roles and Responsibilities, Exams of Nursing

Download Clinical Research Associate (CRA) - Roles and Responsibilities and more Exams Nursing in PDF only on Docsity!

CRA TEST| 110 questions| with complete solutions What does CRA stand for? correct answer: Clinical research associate What's 2 other names for a CRA? correct answer: Trial monitor, clinical monitor What is another name for a study? correct answer: Protocol and clinical trial The main ingredient in a drug is called? correct answer: A compound Pre-clinical trials are done on?? correct answer: Animals, microorganisms, and tissue Before any drug can make it to market how many phases must they go thru? correct answer: 4 phases Which phase is a continuous phase? correct answer: Phase 4 Patients participating in a clinical trial are always? correct answer: Volunteers What is oncology? correct answer: study of cancer When is the only time a patient is not healthy for phase 1? correct answer: It's the patient has aids or cancer; other than that all patients must be healthy in phase 1

At which phase are patients NOT healthy? correct answer: At phase 2 T-F Preclinical trials don't have a phase? correct answer: True What's another name for side effects? correct answer: Toxicity and adverse events What does TMF stand for? correct answer: Trial Master File What is pharmacokinetics? correct answer: the study of drug movement throughout the body An investigator is usually? correct answer: A doctor or physician What's another name for a sugar pill? correct answer: A placebo T-F Preclinical trials involve humans? correct answer: False At what phase would you see healthy patients? correct answer: Phase 1 How many days does the FDA have to approve an application? correct answer: 30 days What's another name for a physician in the clinical field? correct answer: Investigator T-F 4 applications are required to be sent in for pre clinical trial? correct answer: False

What does CRO stand for? correct answer: Clinical research organization Which phase involves the 3+3 design? correct answer: Phase 1 How many types of visits are there? correct answer: 4 visits What is another name for "enrolled"in clinical trial? correct answer: Randomization What is a CV? correct answer: A resume that states the individuals skills and background What is a MP? correct answer: Is the plan that establishes the guidelines for conducting monitoring visits and monitoring related tasks. What are the monitoring guidelines? correct answer: The monitoring guidelines are ICH-GCP Guidelines and FDA Guidelines What are the keypoints of a protocol? correct answer: 1) inclusion/exclusion criteria

2. schedule of assessment
3. study drug
4. SAE/AE
5. prohibited concomitant medication What is CTCAE? And what is it used for? correct answer: Common Terminology Criteria for Adverse Events and it's a

tool used at the site to grade adverse events. The grading is from 1- What is an IM? correct answer: An Investigators Meeting is a meeting in which all PIs, SCs, Medical Team, Sponsor Team, and study team are present to provide a formal training together with all the sites that will be participating on the study. Who is present during a SIV? correct answer: During a SIV the PI, Sub I, SC, and other key staff are present. Who is the Sponsor? correct answer: The actual pharmaceutical or bio-technology company What does IRB stand for? correct answer: Institutional Review Board What does the IRB approval? correct answer: The IRB approval the protocol, acknowledgement of the IB, ICF, All protocol related material, recruitment advertisement, and the IRB approval letter Who are the key staff at the site? correct answer: The key staff at the site are the PI, SC, DC, RC, Pharmacist, and site manager What's the name of the documentation that must be signed and dated by the site prior to scheduling a QV? correct answer: A CDA

In a double blinded study who knows what the subject is receiving? correct answer: In a double blinded study only the Sponsor will know what drug the subject is receiving What is a protocol violation? correct answer: A protocol violation is an alter within the protocol guidelines that affects the subjects safety. What is standard of care (SOC)? correct answer: The normal care provided per the sites guidelines The SIV and COV reports are the only reports that will what? correct answer: That will be sent back to the site after finalization to be filled in the RB/SFN unless specified What information is entered into the CTMS? correct answer: Trip reports (TR), Protocol deviations (PD), and site information Phase 2 trials are usually done in Special clinical centers such as? correct answer: University Hospitals What is a therapeutic area? correct answer: Oncology, Cardiology, General Medicine Clinical trial specialist correct answer: Who is the assistant to the LCRA? Sub-investigator/ Co- investigator correct answer: The back up physician to the PI that also assists with the conduct of the study

Data coordinator correct answer: The person on site that enters the subjects data an answer EDC queries Good clinical practice certificates correct answer: The training certificate for GCP that confirms that the site staff has been trained Financial disclosure form correct answer: A document that confirms that the PI or sub I does not have any financial interest within the study. it is collected at the beginning and at the end of the study Clinical trial agreement/contract correct answer: A contract between the CRO and the site that states the agreement of what's expected within the study Pre-site selection visit (PSSV) correct answer: This visit is conducted in order to confirm whether the site is qualified to participate in the study. There will only be one qualification visit per site per study Site initiation visit correct answer: This visit is connected once the site has been selected and the site receives A greenlight approval. Greenlight approval is an approval that all essential documents have been collected and the IRB has approved the site ready to participate in the study. There will only be one SIV per site per study Post marketing surveillance Trial correct answer: Phase 4 trails are also known as what?

Confidential disclosure agreement correct answer: Legal contract between the CRO/ sponsor and the site that outlines Confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties. It is a contract through which the parties agree not to disclose information covered by the agreement. Study Coordinator SC correct answer: The person that will be the CRA's primary contact at the site. The SC will be delegated to many tasks such as: entering data, reporting SAE's, ordering study drug, scheduling subjects visits, scheduling monitoring visits, and updating the site's regulatory binder Approved budget correct answer: A budget if they agree dollar amounts that will be paid to the site for each subject and visit that is perform for the study. Investigational brochure IB correct answer: A comprehensive document summarizing the body of information about an investigational product. It lists information regarding the safety of the drug and statistical data around the adverse events associated with the drug Clinical Laboratory Improvement Amendments (CLIA) correct answer: A laboratory certificate that certifies that lab. The CLIA expires yearly and an updated copy needs to be collected once the CLIA expires Certified Authorization Professional (CAP) correct answer: And additional certificate that some sites have in addition to the

CLIA. It is a certification. It is an objective measure of the knowledge, Skills and abilities required for personnel involved in the process of authorizing and maintaining information systems Reference ranges RR correct answer: A range of numbers in which a value is placed to determine if a result is normal Site signature delegation log/delegation of authority SSDL/DOA correct answer: A log that has everyone at the site listed along with the task they will perform that was delegated by the principal investigator Standard operation procedure / SOP correct answer: A set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOP's and to achieve efficiency, quality outpour and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations Note To File NTF correct answer: A document that provides a detailed description regarding a discrepancy noted during the clinical study Source document verification SDV correct answer: A review of the data collected from the site to confirm that the data matches what is entered in the EDC system Case report form/electronic case report form CRF/eCRF correct answer: The data that is collected and the EDC are CRFs

Database lock DBL correct answer: A lock of data entered within the EDC system. No changes or queries can be entered if a DBL occurs. They typically occur at the end of the study and is permanent. End of every phase and end of every study Interm analysis/ Soft Lock IA correct answer: A lack of the data answered within the EDC system during set time points of the study. Typically this occurs when certain endpoints are reached. This lock is not a permanent lock. Once the Biostaticians review the data then they will unlock the data. Investigational Product (Drug) correct answer: The actual study drug that is used during a clinical study. Study drug the sponsor is trying to get on market Serious Adverse Event SAE correct answer: Any And toward events that may or may not be related to the study drug which results in death, hospitalization for greater than 24 hours, causes congenital anomaly, causes incapacitation, that is life- threatening, or considered medically significant Adverse Event (AE) correct answer: Any untoward event that may or may not be related to the study drug that was not originally identified within the subjects medical history Protocol Deviation PD correct answer: And alter within a protocol guidelines that do not affect the subject safety. Basically deterred away from what's in protocol. Document on log and retain site and have trained staff sign log

Therapeutic area (TA) correct answer: Refers to a generalized organ system/disease in which a study is being conducted i.e. oncology, cardiology, general medicine Electronica data capture (EDC) correct answer: A system that house is that an answered by each side participating on a clinical study. Only the site can't enter data. The CRA will have read only access and will only be able to question the data (query) or close the query Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA) correct answer: The guidelines/standards set by the FDA for data collection Trial Master File (TMF) correct answer: A system that must be the exact replica of the essential documents that are housed at the site in the regulatory binder Clinical trial management system (CTMS) correct answer: CRA will enter trip reports, track protocol deviations, house all site information Integrated VOICE response system (IVRS) correct answer: Via telephone Integrated WEB response system (IWRS) correct answer: Via Web Regulatory Binder correct answer: A binder that is located at each site which houses all of the sites are essential documents

informed consent form (ICF) correct answer: Subject + PI or delegated site personnel What is another name for trip report correct answer: Monitoring report What are the type of systems used in clinical research? correct answer: EDC, IVRS, IWRS, TMF, CTMS What are the study start up documents/essential documents? correct answer: FDF, CV, CTA, SOA, GCP, IB, Protocol Signature Page, ML, Approved Budget What are the clinical site roles? correct answer: PI, SC, Sub-I, DC , RC International Council for harmonization (ICH) correct answer: ICH is a project that brings together the regulatory authorities of Europe, Japan and the United States and expert from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration What are the Clinical Study Roles correct answer: CRA, PM, COL, CTL, CTM, LCRA, PS, PD, CTS, DM What is a CRA? correct answer: A CRA is a health-care professional who performs many activities related to medical research, particularly clinical trials. What's another name for a CRA? correct answer: Clinical monitor, trial monitor, or site manager

What is the main function of a CRA? correct answer: To monitor clinical trials Monitoring clinical trials consist of what? correct answer: - Review subject data associated with the protocol/ study -Ensure the safety and well being of subjects

• Provide protocol/ study specific training to site personnel -Review essential documents housed in the regulatory binder
• Conduct on-site and phone visits -Complete Trip reports
• Communicate with site personnel on a consistent basis What's another name for patient? correct answer: Subject What's another name for subject? correct answer: Patient Traveling to site are what type of visits? correct answer: On-site visits Another name for a phone visit Is what? correct answer: Remote visit Drug development is??? correct answer: A term used to define the entire process of bringing a new drug or device to the market. It includes drug discovery, preclinical research (microorganism/animals) and clinical trials (on humans) What's the drug development process? correct answer: - Drug development

-Pre-Clinical Studies

• Clinical Trials
• Phase 1 -Phase 2 -Phase 3 -Phase 4 Pre-clinical studies are performed on? correct answer: Animals, microorganisms, tissue What is a New Chemical Entities (NCE)? correct answer: Compounds which emerge from the process of drug discovery What is an Investigational New Drug Application? correct answer: An application filed with the FDA after completion of pre-clinical and prior to human testing A NDA must be submitted after completion of what phase? correct answer: After completion of phase 1, phase 2, phase 3 studies of clinical trials Phase 1 trials are done to determine what? correct answer: Whether humans and animals show a significantly different response to the drug and to establish safe clinical dosage range What are non-blind or open studies? And which phase does this occur in? correct answer: Non-blind or open is when both the investigators and the subjects know what drug is being given to them and this occurs in phase 1

What is dose escalation? And what Phase does it occur? correct answer: Is studies so that the appropriate dose for therapeutic use can be found. It occurs in phase 1 Many predictable toxicities are detected in what phase? correct answer: Phase 1 Clinical Trials are conducted on human volunteers to allow what? correct answer: Safety and efficacy date to be collected for health intervention -Review subject data associated with the protocol/study -ensure the safety and well being of the subjects

• provide protocol/study specific training to site personnel
• Review essential documents housed in the regulatory binder
• conduct onsite and phone visits -complete trip reports
• communicate with site personnel on a consistent basis correct answer: What does monitoring clinical trials consist of? Drug Development is a term used to define the entire process of bringing a new drug or device to the market. It includes: drug discovery, product development, pre-clinical research (microorganisms/animals) and clinical trials (on humans) correct answer: What is Drug Development? CRA work in various settings such as pharmaceutical companies, CRO, medical research institutes, and government agencies. correct answer: Clinical Research Associates work in what kind of settings?