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CRA Interview > CRA Interview > Flashcards

CRA Interview Flashcards

1
Q

FDA’s CFR (Code of Federal Regulations)

A

• Fundamental principle of research ethics
o Respect for persons
 Recognizes the rights of individuals to make their own choices and decisions
o Beneficence
 Researcher is responsible for participants well being
o Justice
 Researcher’s obligation to distribute drug and practices equally
• Title 21 Food and Drugs
o Part 11 = Electronic Records; Electronic Signatures
o Part 50 = Protection of Human Subjects
o Part 54 = Financial Disclosure by Clinical Investigators
o Part 56 = Institutional Review Boards
o Part 200-499 = Drugs
o Part 312 = Investigational new drug application
 Sec 312.32 = IND Safety Reports
• Serious and unexpected suspected adverse reaction
o Part 314 = Application for FDA Approval to market a new drug
o Part 600-699 = Biologics
 Part 600 = Biological products
o Part 800-899 = Medical Devices
 Part 812 = Investigational device exemptions
 Part 814 = Premarket approval of medical device
• Title 45
o OHRP (Office of Human Research Protections) = “the common rule”
o OCR (Office of Civil Rights) – HIPPA

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2
Q

Phase I

A

15-30 pts, 1st in humans

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3
Q

Phase II

A

100-300 pts, determine efficacy and safety

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4
Q

Phase III

A

100-1000s pts, compare agent to standard treatment or placebo
Safety

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5
Q

Phase IV

A

Several hundred or 1000s

Post market, long term safety and efficacy

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6
Q

GCP

A

(Good Clinical Practices)
• International ethical and scientific quality of standard for designing, conducting, recording, and reporting trials with humans
o Protects the rights, safety and welfare of subjects
o Assure quality of data
o Makes trial data credible
• Focus on Rights and safety of pts, data integrity, confidentiality
• EXAMPLES: Draw a single line, initial and date, Data entered by authorized personnel only, EDC keeps audit trail

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7
Q

ICH

A

(International Conference on Harmonization)
• Concerned with quality, safety, and efficacy
• ICH Guidelines
o Trials should be conducted in accordance with ethical practices
o Risks are weighted against benefits
o Rights, safety and wellbeing of subjects
o Must have adequate clinical information to support the trial
o Must be scientifically sound
o Trial must be completed in accordance to the protocol
o Medical decisions for patient always responsibility of physician
o Must explain and train subjects on what their requirements are in the trial
o Freely given informed consent
o Investigation products manufactured, handled and stored in accordance to GMP (good manufacturing practices)

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8
Q

Fundamental Principles of Research Ethics

A
  • Respect for persons - capacity and rights of patients; pts right to choose
  • Beneficence – researcher is responsible for patient’s physical, mental, and social well-being; risks weighed
  • Justice - equal distribution to all patients
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9
Q

Study Start-Up Process

A 
•	Identify sites
•	Contact sites
•	Execute CDA
o	Confidential Disclosure Agreement
	Between site an sponsor in order to share protocol specifics
•	Conduct Feasibility
o	Determines site interest and capabilities to perform study
	Staff and lab info
	Availability of staff
	Patient population
•	How many seen, how often and diagnosis
•	SQV
•	Initiate and Negotiate CTA & Budget
o	Agreement between site and sponsor that outlines each party and responsibilities within the research 
	Includes budget
•	Reg Doc submission and IRB approval
•	SIV
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10
Q

AE

A
  • Untoward medical occurrence

* Record as soon as study drug received to 30 days after last dose

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11
Q

SAE

A 
(21 CR 312.32)
Adverse event where the outcome was
•	Death
•	Life threatening
•	In-patient hospitalization
•	Birth defects
•	Permanent disability 
Must be reported within 24 hours
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12
Q

Regulatory Binder Checklist

A

• Protocol and amendments
• IRB approval
• ICF
o Proper version is signed
o Approved by IRB
o Patient, witness, and PI signatures and dates
 ensure signature dates match
 ensure dates are prior to any study visits and procedures
o Check for initials on each page if necessary
o ensure amended consent is signed if necessary
o ensure nothing was crossed out or altered
• IB and safety info
• Logs and forms (such as drug accountability logs, screening and enrollment logs, 1572, Financial disclosure form
o 1572 – Statement of Investigator
 Agreement signed by investigator to provide information to sponsor, and will comply with FDA regulations related to study (IND studies)
 Provides the sponsor with investigator’s and site qualifications to conduct study
 Signed when investigator is going to participation in a new IND, prior to any study procedures or drug is given
 Resigned if changes such as IRB address change, new subinvestigators, or new research lab has occurred
 What to look for on 1572
• Section 1 = Investigators full name and address
• Section 2 = Education, training (CV)
• Section 3 = Name and addresses of all sites
• Section 4 = Name and address of all labs
• Section 5 = Name and address of IRB
• Section 6 = Names of Subinvestigators
• Section 7 = Name of protocols in the IND to be conducted by investigator
• Section 8 = Protocol information
o Financial Disclosure Form
 FDA Form 3455 – 21CRF 54
 PI and sub’s sign
 Any compension made to PI from sponsor
•
o Drug accountability log
 Lot number
 Visit number
 Date and amount dispensed, initialed by personnel
 Date and amount returned, initialed by personnel
• Delegation of Authority Log
o Log that lists all site members names, roles, and study tasks within the study
o Authorized by the PI
• CV’s & Licenses
• All study communications (correspondence w/sponsor and IRB)
• Training records
• Lab records
• Manuals
• Medwatch forms
• Safety reports
• Blank CRFs

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13
Q

ICF

A

o Proper version is signed
o Approved by IRB
o Patient, witness, and PI signatures and dates
 ensure signature dates match
 ensure dates are prior to any study visits and procedures
o Check for initials on each page if necessary
o ensure amended consent is signed if necessary
o ensure nothing was crossed out or altered

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14
Q

1572

A

– Statement of Investigator
 investigator agrees to comply with FDA regulations related to study (IND studies)
 Provides the sponsor with investigator’s and site qualifications to conduct study
 Signed when investigator is going to participation in a new IND, prior to any study procedures or drug is given
 Resigned if changes such as IRB address change, new subinvestigators, or new research lab has occurred
 What to look for on 1572
• Section 1 = Investigators full name and address
• Section 2 = Education, training (CV)
• Section 3 = Name and addresses of all sites
• Section 4 = Name and address of all labs
• Section 5 = Name and address of IRB
• Section 6 = Names of Subinvestigators
• Section 7 = Name of protocols in the IND to be conducted by investigator
• Section 8 = Protocol information

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15
Q

Financial Disclosure Form

A

 FDA Form 3455 – 21CRF 54
 PI and sub’s sign
 Any compension made to PI from sponsor

PI name, title, organization
Study title
Signature and date

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16
Q

Drug accountability log

A

Log that tracks drug from the time the site receives IP to when its disposed/returned

Date of shipment received, batch number, who received it, quantity of IP
Date dispensed to patient, who dispensed, what patient and visit
Date returned by patient, who received it, and how much received.
Date disposed/returned, by who
CRA monitoring initials and date

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17
Q

Delegation of Authority Log

A

GCP E6 4.1.5

PI delegates tasks to all study staff (nurses, coordinators, sub-is, pharmacist, etc)

Staff name, signature, initials, list of responsibilities, start and stop dates

PI signature at the bottom at the end of study

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18
Q

Quality or SIV

A 
•	All visits require preparation, as in confirm time and date with coordinator, ensure investigator will be present, provide the site with your intended timeline and what you expect to see
•	While there:
o	Introductions
o	Facility Tour
o	Discuss
	Investigators obligations
	Protocol
	Source documentation requirements
	Maintenance of regulatory docs
	IP accountability
	Assess interest and ability of site
•	Write trip report
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19
Q

How would you prepare for a monitoring visit?

A

1) look at previous monitoring trip reports especially if it’s your first time visiting the site to familiarize yourself with the site and see what’s really been going on with the site
2) look at the EDC to see how much time you would need to perform STV
3) look thru EDC and assist in resolving any outstanding queries
4) remote verification to see if there are any protocol deviations
5) write confirmation letter to the site- agree on a specific date and time to visit the site
6) book your travel dates
7) go into IBRS system and print out IBRS report that’s used to perform IP accountability
8) go into TMF system and retrieve the TMF report in order to see all outstanding documents that need to be retrieved at the site

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20
Q

Walk me through an IMV

A
  • All visits require preparation, as in confirm time and date with coordinator, ensure investigator will be present at some point, provide the site with your intended timeline and what you expect to review, ask them to pull files prior to you being there, and/or provide you with a login for electronic records
  • “During a typical day, I would greet the Study Coordinator, sign the visit log, perform SDV (reviewed subjects with SAE’s first, then new enrolled subjects, and then subjects that have been previously SDV’d, check the Regulatory Binder, visit the Pharmacy to do drug accountability, meet with PI, then the Study Coordinator to discuss pending queries, follow up items, enrollment logs, and schedule next visit.

Arrive onsite and sign the monitoring log

Tell the SC your plan for the day to ensure that works for them

Review ICFs of newly enrolled or reconsented subjects

Complete SDV and make a list of discrepancies discovered for the SC to fix while I review the reg binder

Review reg binder for accuracy of logs and completeness of reg docs

Visit the lab and/or pharmacy as necessary

Have a discussion with the PI and SC at the end of the day to go over visit and findings

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21
Q

Walk me through a COV

A

• All visits require preparation, as in confirm time and date with coordinator, ensure investigator will be present at some point, provide the site with your intended timeline and what you expect to review, ask them to pull files prior to you being there, and/or provide you with a login for electronic records.
• While there:
o Sign Monitoring log
o Since it’s close out visit, ensure all CRFs are completed entered and correctly.
o Ensure there are no outstanding queries.
o Ensure all AEs have been captured
o Review reg binder for completeness
 ensure all ICF signed on appropriate version
 protocols and amendment
 IRB Approvals
 Licenses, certifications, CVs
 Lab documentation
 Completeness of all logs (Delegation of Authority, training, screening, enrollment, monitoring,
o Ensure study closure was reported to IRB
o Return or dispose of any remaining IP
• Write trip report

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22
Q

Study Start to Finish

A
  • Synopsis
  • Protocol
  • Identify and contact sites for interest
  • Execute CDA
  • Conduct Site Feasibility
  • SQV
  • Execute CTA and budget
  • Obtain reg docs and irb approval
  • SIV
  • Monitoring, data submission, and cleaning
  • Complete enrollment
  • COV
  • Data analysis, publication, FDA submission if phase iii
23
Q

Monitoring Report

A

• Date, site, my name, names of all those who I made contact with
• Communication log
• Note if any changes in personnel
• Identity my actions
o i.e. review of icfs, reg docs, crfs, etc
• Identify my findings and appropriate the actions that should be taken if needed
o I.e. incomplete crfs, queries, incomplete reg docs, aes, deviations, etc.
o Assure compliance
• Enrollment status

24
Q

Can you tell me a little about yourself?

A

I’m a research professional with 10+ years’ experience in the Clinical Research industry. I started off in the industry quite young. While working I went to college. I received my associate’s degree with honors, then moved onto Texas A&M University where I was highly involved in Certified Aggie Research Scholar Program. All still while working full time.
I started participating in clinical research as a Data Manager and became very interested in Clinical Operations. I was afforded the opportunity at Prometheus to have a split position between DM and clinical where I was able to grow into my CRA role. I’m the type of person that always craves more knowledge because I like to see the whole picture, which is why I often find myself taking on multiple roles at work.

25
Q

Greatest Strength

A

• My organizational skills. Im extremely organized, which helps me better prioritize my tasks and projects. In addition, it helps with communication, in the sense that if I can’t recall something off the top of my head, I know exactly where to go to find the necessary information. Also, because I’m organized, I tend to promote structure in whatever I’m working on.

26
Q

Greatest Weakness

A

• I tend to take on a lot of work because I’m so eager to learn every aspect of what’s going on.

27
Q

How would you describe your ideal job?

A

An ideal job for me would be one that help me enhance my skills while helping me grow professionally and as a person. It would be a job that travel and offer at least one day in my home office.

28
Q

Advantages to Multiple Roles

A
  • I could see error trends within Data Management that helped me better monitor those aspects
  • BC I created the CRFs, I understood the importance of specific data, which I could relay in site training
  • BC I was at the site, I could better understand storage limits to build better lab kit prototypes.
29
Q

Why do you want this job?

A

Love to travel and meet new people

When child, word search was my favorite game and i get the same enjoyment out of finding data discrepancies

Love learning about science and working with sites.
Their passion for patient care and progressive medicine ignites my passion, so I just want to be a part of it all. The best feeling is when the Drs and nurses want the product on market immediately because it’s working wonders on the patients.

30
Q

Why should we hire you?

A

I’m extremely focused and motivated. I’m hungry for this job!!

I understand the importance of working relationships such as:
great rapport with sites and CLs

Take I take pride in finding the most efficient way to complete my tasks.

I’m a team player, but have no problem working independently, or taking initiate when needed.

I have proved in my previous positions that I am capable of taking on high volumes studies and tasks.

31
Q

Where do you see yourself in five years?

A

In 5 years I will be a Clinical Lead for a company that values me as much as I value my work.

32
Q

What other companies are you interviewing with?

A

I’m interviewing with a large CRO, and another small CRO in San Diego

33
Q

What CTMS systems have you worked in?

A

The only e clinical system has been Remarque. All other systems were Microsoft word and excel

34
Q

What’s the greatest number of studies you have worked on?

A

I’ve worked on up to 15 studies between monitoring and managing. However, I’ve monitored up to 7 studies at one time.

35
Q

You’re at a site and discover an unreported SAE, what would you do?

A

Notify coordinator immediately
Site to complete SAE report, EDC entry, and report to the IRB

Retrain the site on reporting requirements (must be reported within 24 hours)
Note retraining on Training Log and in report

Let my internal study team know the same day

36
Q

If a site calls you and asks you if they can add a sub-investigator to their site, what regulatory documents need to be updated?

A

Get an updated 1572
Have sub-i sign FDF
Add sub-i CV, FDF, ML, and GCP to reg binder and TMF
Add sub-i to DOA

37
Q

What do you do when you find a deviation?

A

Notify the SC and PI
Retrain the site on proper protocol procedure and have them document that on the Training Log
Request a Note to File
Have the site report to the IRB if necessary
Notify study team immediately if its a major deviation
Write everything up in the report and document deviation within the CTMS

38
Q

Tell me about a time you had to retrain a Site?

A

There was one site that enrolled up to 3 patients on the study that didn’t qualify. I escalated the issue to the study manager and PI. The study manager went over the protocol in detail with the PI, while I retrained the coordinator and logged the training.
When I retrain site personnel I indicate the specific training on the training log. I sign and date, then request that the personnel sign and date and document that I trained the site personnel in my trip report.

39
Q

How do you manage tight timelines?

A

Put everything in my calendar including date in which specific steps should be completed by, create action item lists for myself and sites, communicate, communicate, and communicate.

40
Q

If the FDA shows up onsite, what would you do?

A

Put all materials back immediately, promptly leave the site undetected, and contact my manager

41
Q

What to know more about this company and what they expect from their employees?

A 
Attributable – original source, author
	Legible
	Contemporaneous – data recorded asap
	Original
	Accurate
	Complete
42
Q

End of interview

A

Nice to meet you
Thank you - i know your time is valuable
I hope I answered all your questions
I look forward to hearing back from you soon

43
Q

PI asks about a drug interaction for current study. how do you handle this situation?

A

I check the protocol and IB to see if i can find the answer, if not i would reach out to the medical monitor on behave of the PI

44
Q

IND

A

Investigation New Product

45
Q

Principle components of an ICF and why important?

A

IRB approved stamped and most current version

all pages must be present (nothing crossed out or altered)

Patient and person consenting signature, date and time. Dates must match and be prior to any study procedure and IP dispensation

Patient initials on each page if required

Person consenting on DOA

For CA: Bill of Rights must accompany the consent with signature and date by the patient

46
Q

Describe the consenting process

A

Person consenting subject goes over the protocol and each page of the consent - answers any questions

Leave the patient alone for ample time to review and think about participation

If ok, both sign and date consent

copy is made for patient, original is filed in subject source

47
Q

What do you feel are opportunities for growth/improvement

A

Like to expand into different fields of research such as vaccinations, neuroscience, and dermatology.

I would like to look into management development opportunities

48
Q

How do you stay current in the clinical research field?

A

read current publications

seek independent professional development courses such as barnett, ACRP, or UCSD extension programs

49
Q

You’re pulled into an urgent meeting and learn your taking over monitoring duties of another CRA for in progress studies. How do you handle this?

A

Introduce myself to the site staff via email and schedule needed visits

While onsite, my main concern is ensure the patient safety and data integrity is intact, so i:
Review all ICFs
Complete a full ISF/TMF reconciliation
Spot check previous monitoring practices by checking eligibility
then perform regulator monitoring activities

50
Q

Describe a time you had a difficult time with a PI and how did you handle it?

A

One time during an SIV, the PI asked me “what’s my incentive to enroll on this study?”
I responded, I believe the incentive would be health and well being of your patients.
He replied, no, what’s in it for me? How much is he and his site staff going to get paid? Is it worth their time?
I politely reminded him that a CTA was signed and the budget had been negotiated and finalized. I added that he could rereview the budget, and if he does not feel that amount reflected is satisfactory, then he could always reach back out to the contract group to try and renegotiate. I then provided him with the appropriate contact, and notified my CL of the situation as soon as I left the site.

51
Q

Tell me about a time you had to deal with a difficult colleague.

A

At one of the companies I worked for, the warehouse had been placing the incorrect tubes in the lab kits and was shipping the kits out late. The warehouse manager would never acknowledge that he or his group did anything wrong. I would try to explain that this is a serious concern, as we only have the right to draw so much blood especially from pediatric patients. He would say it was the Clinical team that never gives him the correct information, so i suggested that moving forward we have weekly meetings to ensure our communication was open and clear. In these meetings, i would frame suggestions in a manner that made him think the whole idea was his, so he felt uplifted versus being put down. These meetings also ensured on time shipments and if there was an issue with a kit build, it could be addressed immediately.

52
Q

When should the site notify the IRB of a deviation?

A

Anytime its a major deviation. So if it affects:
the safety or welfare of a subject, rights of a subject, or the integrity of the study design.

EX:  Failure to obtain consent
ICF signed after study procedures occurred
Drug dispensation error
Failure to report an SAE
No performing all study procedure
53
Q

Examples of source docs

A

Medical records

Progress notes

Medical history and PE reports

Lab and imaging reports

Patient assessments

operative reports

CRA Interview (1 decks)

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