ICON Interview Flashcards
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Questions and Answers

Give an example of a proactive decision you made.

I noticed that a scheduled phone call was due for a subject but had not been made. I asked the CRC about it, and he quickly made the call.

What will you do if there is an SAE that wasn't reported?

Report the SAE within 24 hours, follow up within 15 days, retrain site staff on reporting guidelines, and notify the IRB.

What will you do if you find out that a subject was not properly given informed consent?

Document the issue, inform the PI and CRC, retrain staff, and ensure corrections are made by the next visit.

Give an example of a protocol deviation.

<p>A temperature excursion was noted in the logs. I documented it, trained site staff on storage requirements, and escalated the issue.</p> Signup and view all the answers

What is an SAE?

<p>An SAE is an event that leads to death, prolonged hospitalization, congenital anomaly, life-threatening conditions, or requires intervention to prevent it from becoming an adverse event.</p> Signup and view all the answers

How can you tell if a PI has oversight of a study?

<p>A PI shows oversight by reviewing and signing off on source documents timely, checking lab results within 48 hours, and being available to meet during monitoring visits.</p> Signup and view all the answers

Describe the drug development process?

<ol> <li>Manufacture/develop the compound. 2. In vivo (cellular) testing. 3. Animal research. 4. Clinical research testing in humans.</li> </ol> Signup and view all the answers

What therapeutic areas have you worked in?

<p>Pain, CNS, Cardiovascular, Oncology.</p> Signup and view all the answers

What therapeutic indications have you worked with?

<p>Low back pain, osteoarthritis, depression, schizophrenia, coronary artery disease, solid tumors (breast).</p> Signup and view all the answers

What are clinical trials?

<p>Set tests in medical research and drug development that generate safety and efficacy data for health interventions.</p> Signup and view all the answers

What is a protocol?

<p>A set of guidelines that specifies how a clinical trial will be conducted.</p> Signup and view all the answers

What is an investigational product?

<p>The experimental compound/drug used in the clinical research/trial.</p> Signup and view all the answers

What is phase 1 clinical research?

<p>Research of experimental drug or treatment in a small group of healthy volunteers to evaluate its safety.</p> Signup and view all the answers

What is phase 2 clinical research?

<p>Research of experimental drug or treatment in a small group of subjects to further evaluate drug safety.</p> Signup and view all the answers

What is phase 3 clinical research?

<p>Research of an experimental drug administered to a large group to confirm its effectiveness and monitor side effects.</p> Signup and view all the answers

What is good clinical practice?

<p>An international ethical and scientific quality standard for conducting trials involving human subjects.</p> Signup and view all the answers

Who are the key players in clinical trials?

<p>Sponsor, Site, CRA, and IRB.</p> Signup and view all the answers

List the functions of the CRA?

<p>Ensure the site understands protocol, conduct research in accordance with protocol, and verify the safety of subjects.</p> Signup and view all the answers

What does a medical monitor do?

<p>Makes medical decisions that directly affect subject safety and participation in clinical trials.</p> Signup and view all the answers

What does a project manager do?

<p>Manage the overall project, including allocation of resources and budget.</p> Signup and view all the answers

Who has the overall responsibility of the site?

<p>The Principal Investigator.</p> Signup and view all the answers

A Principal Investigator can delegate work and delegate responsibility of tasks.

<p>False</p> Signup and view all the answers

What are the four types of visits a CRA conducts?

<p>Pre-study selection visit, Site qualification visit, Interim Monitoring visit, and Close out visit.</p> Signup and view all the answers

What is an inpatient and outpatient study?

<p>Inpatient requires patient to be hospitalized; outpatient does not. Inpatient studies are mostly phase 1.</p> Signup and view all the answers

What are the three protocol cycles/periods?

<p>Screening period, treatment period, follow-up period.</p> Signup and view all the answers

What is a screening period?

<p>Time site is given to confirm if a subject is eligible to participate in a study.</p> Signup and view all the answers

What is a treatment period?

<p>Period after eligibility is confirmed and the first dose of study medication is given.</p> Signup and view all the answers

What is the follow-up period?

<p>Period used to assess the subject's health after the last dose of the investigational product.</p> Signup and view all the answers

What is a feasibility questionnaire?

<p>Form completed to gather preliminary information about the site to determine qualification.</p> Signup and view all the answers

What document must be available for each site prior to conducting a PSSV?

<p>A confidential disclosure agreement.</p> Signup and view all the answers

How do you prepare for a PSSV visit?

<p>Confirm visit, send confirmation letter, review protocol, and make copies for distribution.</p> Signup and view all the answers

What questions would you ask during SQV/PSSV?

<p>Questions about PI specialty, enrolment methods, current CV, and necessary site staff.</p> Signup and view all the answers

On average, how many visits are required per month?

<p>8 - 10 site visits per month.</p> Signup and view all the answers

What are the report deadlines?

<p>Draft reports are due in 5 business days and final reports in 10 business days after the visit.</p> Signup and view all the answers

What do you send before a visit and after a visit to a site?

<p>A confirmation letter before and a follow-up letter after a visit.</p> Signup and view all the answers

Example of an issue identified during a PSSV?

<p>CRA noted that blood pressure cuff is due for calibration.</p> Signup and view all the answers

What must each site have before it can be initiated for a study?

<p>A finalized budget and a signed contract.</p> Signup and view all the answers

What documents must the IRB approve?

<p>Protocol, Investigator's Brochure, FDA Form 1572, Financial Disclosure form, and other requested documents.</p> Signup and view all the answers

What do sponsors need before they can release IP to a site?

<p>The FDA Form 1572, Financial Disclosure form, and protocol signature page.</p> Signup and view all the answers

What are all the essential documents?

<p>Protocol, Protocol Amendments, ICF, IRB approval, FDA Form 1572, and various logs.</p> Signup and view all the answers

Where are the essential documents stored?

<p>Site binder/Investigator Site File.</p> Signup and view all the answers

Per GCP guidelines, the site staff has to be qualified by what?

Signup and view all the answers

What is ALCOA?

<p>Attributable, Legible, Contemporaneous, Original, and Accurate.</p> Signup and view all the answers

What must you ensure are in place before you conduct an SIV?

<p>Site has IRB Approval, approved contract, and budget.</p> Signup and view all the answers

What are some study supplies that a site must have at SIV?

<p>Lab kits, investigational product, study-specific equipment.</p> Signup and view all the answers

What is IWRS and what are its functions?

<p>Interactive Web/Voice Response System; manages drug inventory and subject enrollment.</p> Signup and view all the answers

What is an Electronic Data Capture System (EDC) and examples of EDC systems?

<p>Systems like Medidata Rave, Trial Master, DataLabs.</p> Signup and view all the answers

The first place data is recorded is called?

<p>Source document.</p> Signup and view all the answers

What is the trial master file and give examples?

<p>A database of all regulatory documents for sites involved in the protocol; examples include eClinical, IMPALA.</p> Signup and view all the answers

What is a Clinical Monitoring Plan?

<p>A plan specific to a trial indicating how it will be monitored and IMV intervals.</p> Signup and view all the answers

When should the first IMV occur?

<p>Usually within 10 business days after a site has randomized the first subject.</p> Signup and view all the answers

What do you do during a monitoring visit?

<p>Check ICF of new subjects, check for SAE or AE reporting, perform source document verification.</p> Signup and view all the answers

What is an adverse event?

<p>Any unfavorable sign, symptom, or disease associated with the use of a medicinal product.</p> Signup and view all the answers

What is a serious adverse event?

<p>Any adverse event that leads to death, is life-threatening, or requires intervention.</p> Signup and view all the answers

What is a Safety Pharmacovigilance group?

<p>Group that tracks SAEs or events of interest as part of the CRO.</p> Signup and view all the answers

When are sites required to report an SAE and to whom?

<p>Report to the sponsor within 24 hours and notify the IRB within 10 business days.</p> Signup and view all the answers

What is an unexpected adverse reaction?

<p>Adverse reaction not listed in the Investigator's Brochure and is unexpected.</p> Signup and view all the answers

What is the site's responsibility with Adverse Events?

<p>Site must report it to the sponsor, enter it into EDC, and ensure healthcare needs of subject are met.</p> Signup and view all the answers

What is the CRA responsibility with SAEs?

<p>CRA must verify all SAEs, ensure timely reporting, and help resolve any queries.</p> Signup and view all the answers

What is CRA level of access with EMR?

<p>CRA should have access to only research-specific subjects' data.</p> Signup and view all the answers

What will you do if you go to a site and the site has less IP than indicated in IWRS?

<p>Notify IWRS and CTL, address security and IP handling issues.</p> Signup and view all the answers

What will you do if you determine a subject misplaced IP while doing subject-level drug accountability?

<p>Ensure site documents misplace, retrain the subject, and document in IMV report.</p> Signup and view all the answers

What type of IP have you worked with?

<p>Pills stored at room temperature, and IV.</p> Signup and view all the answers

What must be available from the PI and site prior to receiving a controlled substance?

<p>Site needs DEA 222 on site and mailed to supplier; PI needs a DEA 223 license.</p> Signup and view all the answers

How should controlled IP be stored?

<p>IP should be stored in a triply locked, limited access room.</p> Signup and view all the answers

How do you perform IP accountability with a controlled substance?

<p>Accountability should be done with a witness present.</p> Signup and view all the answers

What are the essential documents?

<p>Protocol, Protocol Signature Pages, Investigator's Brochure, ICF template, FDA Form 1572, etc.</p> Signup and view all the answers

If there are changes to the site staff, what should the site do?

<p>New FDA 1572 forms need to be submitted.</p> Signup and view all the answers

What is a financial disclosure form?

<p>All staff listed on FDA 1572 must sign a financial disclosure form.</p> Signup and view all the answers

What is a Delegation of Authority Log?

<p>Log that lists all active site staff and their responsibilities.</p> Signup and view all the answers

What report must be in the site binder?

<p>SIV Trip report.</p> Signup and view all the answers

What log must be signed at each visit?

<p>CRA must sign the site visit log.</p> Signup and view all the answers

Tell me something you have done that has made you proud as a Clinical Research Associate.

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One of your sites just randomized a patient; what do you do if you have no time for an IMV?

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Give an example of a time where you did not have adequate resources or information to perform your job.

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Give an example of a time you had to help or correct a colleague.

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With multiple protocols, how do you stay organized?

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Give an example of a time you had to solve a problem.

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Give an example of a mistake you identified.

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You arrive at a site for an IMV and identify a temperature excursion. What do you do?

<p>Document the deviation, inform the site staff, retrain them on protocol.</p> Signup and view all the answers

You go to the site for a monitoring visit and identify a SAE that was not reported. What do you do?

Signup and view all the answers

What if the site refuses to do the IP accountability?

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You are scheduled to be onsite for 2 days; however, your time is cut short to 4 hours. What do you do?

<p>Review ICF of newly screened subjects and check for SAEs.</p> Signup and view all the answers

You get to the site and the CRC is not around to assist you during the monitoring visit. What do you do?

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What do you look for when reviewing the ICF of a subject?

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What do you look for when reviewing the source document of a subject?

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What is the meaning of ALCOA?

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What does PI oversight mean to you?

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Give an example of a PI without adequate oversight.

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What are the responsibilities of the CTL vs your line manager?

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How were you trained as a CRA?

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What is the most difficult study you have worked on?

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How do you prep for an IMV?

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What do you do during an IMV?

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Do you have experience with electronic medical records?

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Give an example of a time when a customer asked you to make an unethical action, what did you do?

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What will you do if the PI is pushing back on a request?

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What will you do if you are given too many tasks than you can handle?

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Give an example of a time when your interaction with your manager went wrong?

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Study Notes

Drug Development Process

  • The process includes manufacturing/developing the compound, in vivo testing, animal research, and clinical research testing in humans.

Therapeutic Areas

  • Experience in Pain, Central Nervous System (CNS), Cardiovascular, and Oncology.

Therapeutic Indications

  • Focus on low back pain, osteoarthritis, depression, schizophrenia, coronary artery disease, and solid tumors (e.g., breast cancer).

Clinical Trials

  • Defined as tests in medical research and drug development, aimed at generating safety and efficacy data.

Clinical Trial Protocol

  • A set of guidelines specifying how a clinical trial will be conducted.

Investigational Product

  • Refers to the experimental compound/drug used in the clinical trial.

Phases of Clinical Research

  • Phase 1: Tests on 20-80 healthy volunteers to evaluate safety and dosage range.
  • Phase 2: Involves 100-300 subjects to further evaluate drug safety and tolerability.
  • Phase 3: Conducted on 1000-3000 patients to confirm effectiveness and monitor side effects.

Good Clinical Practice (GCP)

  • An international ethical standard ensuring rights, safety of human subjects, and the credibility of trial data.

Key Players in Clinical Trials

  • Include sponsors, site staff, Clinical Research Associates (CRAs), and Institutional Review Boards (IRBs).

Functions of Clinical Research Associates (CRA)

  • Act as the sponsor's eyes and ears, ensure protocol understanding, conduct research according to guidelines, verify safety, and check data credibility.

Medical Monitor

  • Responsible for medical decisions affecting subject safety in clinical trials.

Principal Investigator (PI)

  • Holds overall responsibility for the site and ensuring adherence to the study protocol.

Site Visits

  • Types include Pre-Study Selection Visit (PSSV), Site Qualification Visit (SQV), Interim Monitoring Visit (IMV), and Closeout Visit.

Inpatient vs. Outpatient Studies

  • Inpatient studies require hospitalization, primarily associated with Phase 1 trials; outpatient refers to Phase 2 and 3 studies.

Study Reporting Periods

  • Encompass screening, treatment, and follow-up periods for subject assessment.

Feasibility Questionnaire

  • Used to gather preliminary information about a site’s qualification.

Essential Documents for Studies

  • Include Protocol, Investigator’s Brochure, Informed Consent Forms, IRB approvals, and various logs and agreements.

Adverse Events (AE) and Serious Adverse Events (SAE)

  • AE: Any unfavorable sign or symptom associated with medicinal product use.
  • SAE: Adverse events leading to death, hospitalization, disability, or requiring intervention.

Safety Pharmacovigilance Group

  • Monitors SAEs and important events as part of the Clinical Research Organization (CRO).

Reporting Procedures for SAE

  • Must report to the sponsor within 24 hours and notify IRB within 10 business days.

ALCOA Principles

  • Ensures data is Attributable, Legible, Contemporaneous, Original, and Accurate.

Interactive Web/Voice Response System (IWRS)

  • Manages drug inventory, site replenishments, and maintains subject screening logs.

Electronic Data Capture (EDC) Systems

  • Examples include Medidata Rave, Trial Master, and DataLabs.

Source Document

  • The first place where data is officially recorded.

Clinical Monitoring Plan

  • Outlines monitoring procedures and intervals for each site within a clinical trial.

Preparing for Monitoring Visits

  • Involves reviewing protocols, confirming participant eligibility, and ensuring necessary documentation is available.

Addressing Issues at Site Visits

  • Includes documenting issues, retraining staff, and ensuring adherence to study protocols.

Protocol Deviations

  • Any deviations from set protocols must be documented, reported, and retraining conducted to prevent recurrence.### Deviation Management
  • A deviation was documented regarding protocol storage requirements.
  • Site staff were informed and retrained on the necessary protocols for storage.

Investigating the Incident

  • Identification was made of the Investigational Product (IP) affected by the excursion.
  • Subjects that were dispensed the affected IP were also identified if applicable.
  • The issue was escalated to the Clinical Team Leader (CTL) and Medical Monitor.

Documentation and Follow-up

  • A temperature log copy was sent to the CTL for review.
  • The IP vendor provided documentation confirming the IP was suitable for use post-issue.
  • The incident was documented in the trip report for record-keeping.

Serious Adverse Event (SAE) Definition

  • SAE refers to any event leading to death, prolonged hospitalization, hospitalization for over 24 hours, congenital anomalies, birth defects, disabilities, life-threatening conditions, or requires interventions to prevent escalation to an adverse event (AE).
  • Any AE deemed life-threatening by the Principal Investigator (PI) also qualifies as an SAE.

Principal Investigator (PI) Oversight

  • Effective oversight by a PI is indicated by timely reviews and sign-offs on source documents.
  • The PI should review and sign subject screening records before randomization.
  • Lab results must be reviewed within a 48-hour window.
  • Continuous assessment of AEs and SAEs is necessary.
  • The PI should be available for meetings during Interim Monitoring Visits (IMV).

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Prepare for your ICON interview with these flashcards covering essential questions and definitions related to drug development processes and therapeutic areas. Each card presents a question along with a comprehensive answer to help you ace your interview.

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