Podcast
Questions and Answers
Give an example of a proactive decision you made.
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?
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?
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.
Give an example of a protocol deviation.
What is an SAE?
What is an SAE?
How can you tell if a PI has oversight of a study?
How can you tell if a PI has oversight of a study?
Describe the drug development process?
Describe the drug development process?
What therapeutic areas have you worked in?
What therapeutic areas have you worked in?
What therapeutic indications have you worked with?
What therapeutic indications have you worked with?
What are clinical trials?
What are clinical trials?
What is a protocol?
What is a protocol?
What is an investigational product?
What is an investigational product?
What is phase 1 clinical research?
What is phase 1 clinical research?
What is phase 2 clinical research?
What is phase 2 clinical research?
What is phase 3 clinical research?
What is phase 3 clinical research?
What is good clinical practice?
What is good clinical practice?
Who are the key players in clinical trials?
Who are the key players in clinical trials?
List the functions of the CRA?
List the functions of the CRA?
What does a medical monitor do?
What does a medical monitor do?
What does a project manager do?
What does a project manager do?
Who has the overall responsibility of the site?
Who has the overall responsibility of the site?
A Principal Investigator can delegate work and delegate responsibility of tasks.
A Principal Investigator can delegate work and delegate responsibility of tasks.
What are the four types of visits a CRA conducts?
What are the four types of visits a CRA conducts?
What is an inpatient and outpatient study?
What is an inpatient and outpatient study?
What are the three protocol cycles/periods?
What are the three protocol cycles/periods?
What is a screening period?
What is a screening period?
What is a treatment period?
What is a treatment period?
What is the follow-up period?
What is the follow-up period?
What is a feasibility questionnaire?
What is a feasibility questionnaire?
What document must be available for each site prior to conducting a PSSV?
What document must be available for each site prior to conducting a PSSV?
How do you prepare for a PSSV visit?
How do you prepare for a PSSV visit?
What questions would you ask during SQV/PSSV?
What questions would you ask during SQV/PSSV?
On average, how many visits are required per month?
On average, how many visits are required per month?
What are the report deadlines?
What are the report deadlines?
What do you send before a visit and after a visit to a site?
What do you send before a visit and after a visit to a site?
Example of an issue identified during a PSSV?
Example of an issue identified during a PSSV?
What must each site have before it can be initiated for a study?
What must each site have before it can be initiated for a study?
What documents must the IRB approve?
What documents must the IRB approve?
What do sponsors need before they can release IP to a site?
What do sponsors need before they can release IP to a site?
What are all the essential documents?
What are all the essential documents?
Where are the essential documents stored?
Where are the essential documents stored?
Per GCP guidelines, the site staff has to be qualified by what?
Per GCP guidelines, the site staff has to be qualified by what?
What is ALCOA?
What is ALCOA?
What must you ensure are in place before you conduct an SIV?
What must you ensure are in place before you conduct an SIV?
What are some study supplies that a site must have at SIV?
What are some study supplies that a site must have at SIV?
What is IWRS and what are its functions?
What is IWRS and what are its functions?
What is an Electronic Data Capture System (EDC) and examples of EDC systems?
What is an Electronic Data Capture System (EDC) and examples of EDC systems?
The first place data is recorded is called?
The first place data is recorded is called?
What is the trial master file and give examples?
What is the trial master file and give examples?
What is a Clinical Monitoring Plan?
What is a Clinical Monitoring Plan?
When should the first IMV occur?
When should the first IMV occur?
What do you do during a monitoring visit?
What do you do during a monitoring visit?
What is an adverse event?
What is an adverse event?
What is a serious adverse event?
What is a serious adverse event?
What is a Safety Pharmacovigilance group?
What is a Safety Pharmacovigilance group?
When are sites required to report an SAE and to whom?
When are sites required to report an SAE and to whom?
What is an unexpected adverse reaction?
What is an unexpected adverse reaction?
What is the site's responsibility with Adverse Events?
What is the site's responsibility with Adverse Events?
What is the CRA responsibility with SAEs?
What is the CRA responsibility with SAEs?
What is CRA level of access with EMR?
What is CRA level of access with EMR?
What will you do if you go to a site and the site has less IP than indicated in IWRS?
What will you do if you go to a site and the site has less IP than indicated in IWRS?
What will you do if you determine a subject misplaced IP while doing subject-level drug accountability?
What will you do if you determine a subject misplaced IP while doing subject-level drug accountability?
What type of IP have you worked with?
What type of IP have you worked with?
What must be available from the PI and site prior to receiving a controlled substance?
What must be available from the PI and site prior to receiving a controlled substance?
How should controlled IP be stored?
How should controlled IP be stored?
How do you perform IP accountability with a controlled substance?
How do you perform IP accountability with a controlled substance?
What are the essential documents?
What are the essential documents?
If there are changes to the site staff, what should the site do?
If there are changes to the site staff, what should the site do?
What is a financial disclosure form?
What is a financial disclosure form?
What is a Delegation of Authority Log?
What is a Delegation of Authority Log?
What report must be in the site binder?
What report must be in the site binder?
What log must be signed at each visit?
What log must be signed at each visit?
Tell me something you have done that has made you proud as a Clinical Research Associate.
Tell me something you have done that has made you proud as a Clinical Research Associate.
One of your sites just randomized a patient; what do you do if you have no time for an IMV?
One of your sites just randomized a patient; what do you do if you have no time for an IMV?
Give an example of a time where you did not have adequate resources or information to perform your job.
Give an example of a time where you did not have adequate resources or information to perform your job.
Give an example of a time you had to help or correct a colleague.
Give an example of a time you had to help or correct a colleague.
With multiple protocols, how do you stay organized?
With multiple protocols, how do you stay organized?
Give an example of a time you had to solve a problem.
Give an example of a time you had to solve a problem.
Give an example of a mistake you identified.
Give an example of a mistake you identified.
You arrive at a site for an IMV and identify a temperature excursion. What do you do?
You arrive at a site for an IMV and identify a temperature excursion. What do you do?
You go to the site for a monitoring visit and identify a SAE that was not reported. What do you do?
You go to the site for a monitoring visit and identify a SAE that was not reported. What do you do?
What if the site refuses to do the IP accountability?
What if the site refuses to do the IP accountability?
You are scheduled to be onsite for 2 days; however, your time is cut short to 4 hours. What do you do?
You are scheduled to be onsite for 2 days; however, your time is cut short to 4 hours. What do you do?
You get to the site and the CRC is not around to assist you during the monitoring visit. What do you do?
You get to the site and the CRC is not around to assist you during the monitoring visit. What do you do?
What do you look for when reviewing the ICF of a subject?
What do you look for when reviewing the ICF of a subject?
What do you look for when reviewing the source document of a subject?
What do you look for when reviewing the source document of a subject?
What is the meaning of ALCOA?
What is the meaning of ALCOA?
What does PI oversight mean to you?
What does PI oversight mean to you?
Give an example of a PI without adequate oversight.
Give an example of a PI without adequate oversight.
What are the responsibilities of the CTL vs your line manager?
What are the responsibilities of the CTL vs your line manager?
How were you trained as a CRA?
How were you trained as a CRA?
What is the most difficult study you have worked on?
What is the most difficult study you have worked on?
How do you prep for an IMV?
How do you prep for an IMV?
What do you do during an IMV?
What do you do during an IMV?
Do you have experience with electronic medical records?
Do you have experience with electronic medical records?
Give an example of a time when a customer asked you to make an unethical action, what did you do?
Give an example of a time when a customer asked you to make an unethical action, what did you do?
What will you do if the PI is pushing back on a request?
What will you do if the PI is pushing back on a request?
What will you do if you are given too many tasks than you can handle?
What will you do if you are given too many tasks than you can handle?
Give an example of a time when your interaction with your manager went wrong?
Give an example of a time when your interaction with your manager went wrong?
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).
Studying That Suits You
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Description
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.
