CRA Interview

What would you do if you got to a site and they told you they didn't have time for you?

- First, clarify who "they" are. You can usually perform some tasks associated with the visit (e.g., regulatory binder review, some aspects of study drug reconciliation) even if primary personnel aren't available. Determine the root cause of their unavailability. Discuss the issue with the Principal Investigator and the (site's) site manager. Keep Project Management apprised of the situation as it develops and in real time.

Why do you want to work for IQVIA? Why did you choose to apply at IQVIA?

- Patient advocacy - Best Multinational Workplace - 401(k) match up to 3% of your base salary and then 3% at 50% - Competitive 'per diem' strategy -CRA training Program - Regulation, and structure -Tuition reimbursement -Oncology experience

What is the CRA job?

-First ling representative for the sponsor of the trials -Oversees the activities of the site personnel who are actually carrying out the clinical research

How would you handle a coordinator that was not getting the work completed in a timely manner.

-Help the coordinator find solutions to the barriers of him/her completing the work on time. -I will identify her difficulties , If she has a lot to do due to high enrollment, I will escalate to the PI to have an additional delegated assistant coordinator to help her, if she has difficulties with the eCRF and IVRS and IWRS, I will retrain her, I will also retrain her on the protocol, especially in regard to dosing, subject visit windows as specified by the protocol

What databases do you know?

-OpenClinica -BioClinica (CTMS -SharePoint) -eTMF (Trial Interactive) and PhlexEview -DM Net

Which tasks do you complete at a site first if the following are occurring?

-Patient needs to be source verified and is now on C3D15 -You did not meet with the physician on your last visit and need to meet with them on this one - There are two newly registered patients beginning treatment the day you have arrived for your visit - You need to perform drug accountability?

What is required in an informed consent?

1. Description of Clinical Investigation 2. Risks and Discomforts 3. Benefits 4. Alternative Procedures or Treatments 5. Confidentiality 6. Compensation and Medical Treatment in Event of Injury 7. Contacts 8. Voluntary Participation

What are some regulatory documents required to start a clinical trial.

1572, FDFs, Protocol Training for PI, SC and Pharmacists, Protocol Approval

What salary do you prefer to receive?

80,000k the least

Do you understand what a 'double-blind' trial is?

A 'double-blind' trial is a clinical trial in which neither patients nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or standard treatment. Yes, I do understand 'double-blind' trials. In this type of trial, like a controlled trial, one group of participants receives the experimental drug or treatment while another group receives a placebo or standard treatment. The difference is, in a 'double-blind', neither the staff working the trial nor the participants is aware which group is receiving which treatment.

Can A Participant Leave A Clinical Trial At Any Point?

A participant can leave a clinical trial at any time. The participant should let the research team know when withdrawing from the trial and the reasons for leaving the study.

Interactive Voice Response (IVR) Systems

A technology that facilitates access to the database from signals transmitted by telephone to retrieve information and enter data.

What Is A Control Or Control Group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

What Is A Placebo?

A placebo is an inactive pill, liquid or powder that has no treatment value. In a placebo controlled trial, some portion of the participants will receive placebo instead of an active drug or experimental treatment to assess the experimental treatment's effectiveness and safety relative to no treatment at all.

What Is A Prospective, Randomized, Double-blind, Controlled Clinical Trial?

A prospective, randomized, double-blind, controlled clinical trial is the most rigorous clinical trial design, and the one that regulatory agencies mandate must be conducted to demonstrate a medication's effectiveness and safety. In a new drug application, these studies represent the highest quality data regarding the drug and its actions, and form the basis for approval. In this study design, patients are carefully selected for participation and are randomly assigned to receive the experimental drug or a matching active drug or placebo. Neither the patient nor the treating physician knows which treatment was provided, thereby eliminating possible bias. Individual definitions of the study descriptions are: Prospective: Forward looking, beginning before the patient has started treatment. Randomized: Patients are randomly assigned to receive the experimental treatment or alternative (e.g. standard of care or placebo) Double-blind: Neither patients nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or standard treatment. Controlled: One group of patients will be given an experimental drug or treatment, while a second group is given either a standard treatment for the illness or a placebo.

Are you familiar with what a protocol is with regard to clinical research?

A protocol is the plan that the clinical trial is based upon. It describes the details regarding what people may participate in the trial as well as tests, medications, and length of the study. Yes, I am familiar with the term 'protocol.' With regard to clinical trials, it is the guide or plan that describes how a trial is to be carried out. It lists what types of patients may participate, what tests or procedures need to be done, the medications, dosages, etc. that need to be monitored.

What Is A Protocol?

A protocol is the study plan on which the clinical trial is based. Each trial is carefully designed to safeguard the health of participants as well as answer specific research questions. The protocol describes in detail what types of people may participate in the trial, the schedule of tests, procedures, medications, dosages, and length of the study.

How would I handle discussing a difficult topic with a site, coworker or client?

Always keep a respectful tone and never take things personally. If I am having difficulty, I would get tips from my manager or mentor on ways to address it.

Define an SAE

Any adverse event that: · Results in death · Is life threatening, or places the participant at immediate risk of death from the event as it occurred · Requires or prolongs hospitalization · Causes persistent or significant disability or incapacity · Results in congenital anomalies or birth defects · Is another condition which investigators judge to represent significant hazards Must be reported to Sponsor within 24 hours- subject id, time and date, cause

Adverse Event (AE)

Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research. All AEs are collected on an Adverse Event Form, either in paper or electronic format. A sample AE Form is shown in Adverse Event Form. All AEs experienced by the participant during the time frame specified in the protocol (e.g., from the start of intervention through the end of the study) are to be reported, as outlined in the protocol.

What does ALCOA stand for?

Attributable Legible Contemporaneous Original Accurate

Who Can Participate In A Clinical Trial?

Before joining a clinical trial, a participant must meet certain criteria. This is an important aspect of any clinical trial to ensure that the treatment is being investigated accurately and safely. Factors that allow someone to participate in a clinical trial are called "inclusion criteria," and those that disallow someone from participating are called "exclusion criteria." These criteria are used to identify appropriate participants. Acceptance of a participant into a clinical trial is based on such factors as age, gender, the type and stage of disease, previous treatment history, and other medical conditions. For example, some research studies seek participants with specific illnesses or conditions, while others need healthy participants. Some studies may include only men, some studies may include men and women but not women of child-bearing potential, and some studies may include men and women within a specific age range (ie, 18-65 years of age). These criteria are defined by the amount of scientific and safety information that is known about a treatment being tested at the time the trial is planned to start.

Who Sponsors A Clinical Trial?

Clinical trials can be sponsored or funded by a variety of organizations or individuals including physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to government agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), Human Health and Services (HHS), and the Department of Veteran's Affairs (VA).

What is Case Report Tabulation (CRT)?

CRT's are sent to the FDA whenever a pharmaceutical company is submitting an NDA.

What tools are used by clinical research team?

Checklist (Inclusion/Exclusion Criteria, Consenting, Protocol, SAE logs, visit logs, protocol deviations, EDCs, Regulatory Binders, etc. )

Explain Clinical Research

Clinical research refers to any kind of investigation in human subjects which aims to discover or check the clinical, pharmacological, and other pharmacodynamic effects of an investigational product.

What Are The Phases Of Clinical Trials?

Clinical trials are conducted in a series of stages, called phases, each having specific goals. This process provides information about the treatment in a controlled process intended to also protect the participants. The number of participants in each phase of the trial may be based on the overall incidence of the condition being studied. Clinical trials are usually classified into one of four phases: Phase 1: Sometimes called dosing, pharmacokinetic, or clinical pharmacology studies, these trials test methods of administering the treatment (e.g. by mouth, injection, etc.) and how often, as well as the safety of the treatment. These trials usually involve a small number of healthy participants (20-80 healthy volunteers). Phase 2: These trials continue to test the safety of the treatment and evaluate how well the treatment is tolerated and how well it works. Phase II studies usually evaluate the treatment in a specific condition. These trials usually involve 100-300 patients. Phase 3: These trials compare the experimental treatment to the current standard of treatment for a specific condition, establishing both efficacy and adverse events. Participants are usually assigned to either receive the experimental treatment or the current standard. Phase III trials typically enroll large numbers of patients (1,000-3,000) and may be carried out at hospitals and doctors' offices nationwide. Phase 4: Post-marketing studies to gain a greater understanding of the treatment, including its risks, benefits, and optimal use. Depending on the purpose of these studies they may be small studies like the Phase I type OR may be even larger than a Phase III study.

What Is a Clinical Trial?

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must first be studied in laboratory animals to determine its safety before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise in the animal model are then moved into clinical trials. Clinical trials are an integral part of new product discovery and development, and are required by all regulatory agencies (e.g. the Food and Drug Administration (FDA) in the United States), before a new product can be brought to the market.

Code of Federal Regulations (CFR)

Codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government, including FDA CFR is divided into 50 titles

Give Examples Of Edit Ckecks You Made In Your Programs?

Demographic: Body mass index is below expected and Weight is outside expected range (check weight and height). DOB is greater than the Visit date or not. The Gender value is a valid one or invalid. Age is not within expected range. Adverse Event: Visit Start is before birthdate or Stop is before the start. Study medicine discontinued due to the adverse event but completed Labs: Result is within the normal range and also abnormal is not blank or the case can be 'N'Result is outside the normal range and also abnormal is blank. Vitals: Diastolic Blood pressure more than Systolic Blood Pressure Medical History: Visit date prior to Screen date Physical Physical exam is normal and also comment included

What are essential documents?

Essential documents to conduct clinical trials are protocol to conduct the clinical trials ,informed consent forms, approvals from regulatory authorities, sponsors, IRB/IEC approvals, investigational brochure etc

What is the meaning of Ethical (proper definition & not as per google)

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large.

Expected AE

Event is known to be associated with the intervention or condition under study.

Are you familiar with what 'expanded access' means?

Expanded access is the term used to describe the means by which manufacturers make new drugs that are being investigated available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. If you have experience working with patients who have been given expanded access, share some details, as appropriate. If you don't have personal experience, share your knowledge. I do have some knowledge about 'expanded access' although I have not worked directly with patients who have been giveThe manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug.

What are your strengths and weaknesses?

Experience proficient in Microsoft word, excel and outlook. Problem solver. Detailed oriented, prioritizing tasks, analyzing a situation, complete tasks within a timely manner. Get tasks completed right away, hard working, flexible, adaptable, team player, Weakness: I'm anal when it comes to drug accountability.

Tell me how you would react if a CRC would not give you a document or piece of information.

First I will try to get it from CRC and if it doesn't work then I will approach to PI and ask him to get the document by explaining the importance of document and consequences if it is not provided.

What Should One Expect During A Clinical Trial?

For all types of trials, participants work with a research or clinical trial team, including doctors, nurses, social workers, and other health care professionals. Prior to the trial, the research team will check the health of the participant and review any special instructions for trial participation. As the trial begins and throughout its duration, the research team will administer treatment, (whether that be the experimental treatment, a standard treatment or a placebo depending on the requirements of the study) and monitor the participant on a regular basis to determine effectiveness and side-effects of the treatment. Ongoing communication is an important part of any clinical trial and after the trial has been completed the research team will stay in touch with the participant for a specified period of time to assess any effects of the treatment after treatment has stopped. The data collected before, during and after the trial is a crucial component to the drug's approval submission to drug regulatory agencies.

How would you handle a coordinator that was not getting the work completed in a timely manner?

I would email the coordinator reminding he or she about the task at hand. I would then call the coordinator to ensure they have received the instructions. I would send a follow up email with the PI cc'ed. If the coordinator was still not compliant, I would send another email cc'ing the project manager.

How do you remain organized?

For each study I create a step by step approach by which I will complete the tasks accordingly. I will create a list of tasks in accordance with their urgency. I handle the tracking of new IRB document with a red pen. At the site, we would photo copy new consents in different colored paper.

If a trial participant asks you to explain what a placebo is and why it may be used, what would your answer be?

I would explain to the participant that a placebo is an inactive pill, liquid or powder that has no treatment value. I will further explain that in a placebo controlled trial, some portion of the participants will receive placebo instead of an active drug or experimental treatment and that this is done to assess the experimental treatment's effectiveness and safety versus no treatment at all. I will tell the participant that a placebo is a liquid, powder, or pill that has no treatment value and that is used in clinical trials to help determine the difference between the active drug or experiment compared to no treatment at all.

Tell me about a time when an unexpected assignment required you to set aside your planned responsibilities. How did you handle it?

I would first analyze between the responsibilities I currently have and the unexpected assignment as to which is more urgent. If the unexpected assignment was not as urgent as the task at hand, I would notify whomever is requesting the assignment as to a timeline in which I will complete the task.

What Is Informed Consent?

Informed consent is the verification of a person's willingness to participate in a research project. Prior to enrollment in a clinical trial, researchers inform participants about all relevant study details and known risks. Participants are then provided an informed consent document that details all the important study information including its purpose, duration, risks, potential benefits, required procedures, and key contacts. Once participants have had a chance to read this form and ask questions, if they agree to participate in the trial, they will be asked to sign an informed consent document. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled. The research team actively maintains informed consent throughout the entire trial by providing the participant with any new or developing information, as needed.

What is a 1572?

It provides the sponsor with information about the investigator's qualifications and the site that enables the sponsor to establish and document that the investigator is qualified and the site is an appropriate location to conduct the study To inform the investigator of his/her obligations and obtain the investigator's commitment to follow FDA regulations.

What is the most important part of a 1572?

Locations where the trial is being done

Tell About Domains/datasets You Have Used In Your Studies?

Medical History, ECG, Labs , Demog , Physical Exam, Adverse Events ,Vitals etc

Unexpected SAE

Nature or severity of the event is not consistent with information about the condition under study or intervention in the protocol, consent form, product brochure, or investigator brochure.

Clinical trials can be of several types. These are as follows:

New approaches of prevention trials test like medications, vitamins, or other supplements which according to doctors may can lower the risk of development of a certain type of cancer. Generally the prevention trials are conducted with healthy people with no cancer history. Certain trials are also conducted with people who have cancer and want to reduce the chance of developing a new type of cancer or returning of cancer. Diagnostic trials are conducted usually on people who shows signs or symptoms of cancer whereas treatment trials are conducted with the people who actually have cancer. They answer certain questions and effectiveness of new treatment or a new way of using a standard treatment is judged. These trials test treatments such as new drugs, new approaches to surgery or radiation therapy, vaccines, or new combinations of treatments supportive care (also called Quality-of-life) trials explore ways to improve the comfort and quality of life of cancer patients and its survivors. These trials will be helpful in the study of treatment of patients experiencing nausea, vomiting, depression, sleep disorders, or other effects from cancer or its treatment. To detect cancer earlier screening trials are done and are often conducted to determine whether finding cancer at early stage of symptoms decreases the chance of dying. These trials include people who do not have any signs of cancer. Diagnostic trials study could be used to identify cancer more accurately. They are sometimes part of another cancer clinical trial. The genetics component of the trial also focus on how genetic makeup can affect diagnosis, detection, or response to cancer treatment.

What are some of the risks associated with being a participant in a clinical trial?

One of the main risks that many participants and the healthcare team is concerned with is potential side-effects that are known and those that have not yet been identified One of the frustrating things about clinical trial risk is that participants may not know that they are receiving a placebo and, as a result, will not have the outcome they had hoped for.

Last Observation Carried Forward (LOCF)

Pharmaceutical companies spend several months to conduct longitudinal studies on human subject. It is unrealistic to expect patients to keep timely visit over such a long period of time. Despite all the efforts, patient data are not collected for some and these become missing values in a SAS data set later. For reporting, the most recent previously available value is substituted for each of the missing visits. LOCF doesn't mean the last SAS dataset observation which gets carried forward rather it means last non-missing value carried forward. It is the values of individual measures which are actually "observations" in this case. Also if there are multiple variables containing these values then they will be carried forward independently.

There are Five phases of clinical Trials:

Pre-clinical: animal tests and In vitro (test tube), to determine dosing and any other potential risks to administration in the human beings. Phase One: The determination of safe doses of a new drug by trials on healthy human volunteers and the drug's effect on the body (pharmacodynamics) and the body's effect on the drug (pharmokinetics). Often performed by CROs (Contract Research Organisations) or in large teaching hospitals. Phase Two: Treatment or the experimental drug is given to a large group of people (100-300) to see that the drug is effective or not for that treatment. Phase Three: Studies with large numbers of patients undertaken by GPs or in hospital. Comparing of the efficiency and side effects of the drug with existing placebos and treatments. Phase Four: Is performed after the product license has been granted by the regulatory authorities. Industry conducts large, long term epidemiological studies to assess optimal use and for the marketing strategy of the drug these are essential. Safety (pharmacovigilance) is monitored by post marketing surveillance studies.

How would you handle a provider who was not following the Protocol?

Re-educate the provider on importance of following protocol and potential of risking subject safety if going outside the parameters of protocol. Then escalate to PM and/or MM

If you had your choice of a research project to work with, what would you choose?

Research is such an exciting industry. If I had a choice, I would love to work on any project that has to do with cancer research. Cancer is a dreadful diagnosis and I would love to have some part in helping to find better ways to treat and hopefully cure it. I have always wanted to work in research, but I really don't know if I have a favorite or preferred area. Things change so quickly within our industry that I feel like any area I work in would be exciting.

Why Statistical Analysis Plan (SAP) Is Important?

SAP is the document that contains detailed information regarding the statistical methods and study objectives to help in the production of the Clinical Study Report (CSR) including figures, summary tables, and subject data listings for Protocol. Documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis are also contained in this.

What Are Side Effects And Adverse Reactions?

Side effects include any undesired actions or effects of a drug or treatment. Experimental drugs must be evaluated for both immediate and long-term side effects.

Describe the consenting process.

The consent form should be obtained prior to study procedures. Process documented in Source: -Date and Time -Version Reviewed -Study personnel conducting the discussion(s) -Topics discussed with participant Adequate time for review of consent and questions Participant received copy of consent document Valid signatures and dates are present Correct version was signed, including the updates

Why Participate In A Clinical Trial?

The decision to participate in a clinical trial is one that should be made by the patient and his/her loved ones working in close communication with the physician. Participants in clinical trials play a key role in drug development and discovery; clinical trials contribute to knowledge and progress in treating and preventing diseases. First and foremost participants can help others by contributing to medical knowledge and improving public health. Further, a participant does not need to be a patient diagnosed with a specific disease or health problem as some clinical trials, focusing on safety, will include healthy volunteers. Patients who take part in clinical trials may benefit from the treatments they receive. As part of a clinical trial, a patient will receive either the experimental treatment being tested, an accepted standard treatment for the condition, or a placebo. It is important to understand that there is no guarantee that any treatment received in a clinical trial will produce the desired results.

Contract Research Organizations such as IQVIA employ people from many different backgrounds with a variety of skills. Have you ever worked with a very diverse group of people?

The largest diverse group I worked with was probably when I did my clinical rotation at University Medical Center. I was afforded the opportunity to meet people from different cultures, religions, and professional backgrounds. It gave me an eye-opening experience of how many wonderful people there are! I think diversity in the healthcare industry is essential. People from all over the world now call our country their home. I believe learning about and showing an appreciation for people from different walks of life only makes us stronger as we build upon the common bond of caring for others.

Clinical Research Managers (CRM)

They supervise informed consent forms for clinical trials, case report forms and design and writing of protocols. CRM ensures that Case Report Forms are reviewed timely and submitted to the data management group.

Explain verification.

Verification ensures the accuracy of the final tables and the quality of SAS programs which generates the final tables. I selected the subset of the final summary tables for verification according to the instructions SOP and SAP.

Describe a situation in which you made an error. What happened and what did you do about it?

Zambia- List of SOPs.

AE Relatedness

· Definitely Related: The adverse event is clearly related to the investigational agent/procedure - i.e. an event that follows a reasonable temporal sequence from administration of the study intervention, follows a known or expected response pattern to the suspected intervention, that is confirmed by improvement on stopping and reappearance of the event on repeated exposure and that could not be reasonably explained by the known characteristics of the subject's clinical state. · Possibly Related: An adverse event that follows a reasonable temporal sequence from administration of the study intervention follows a known or expected response pattern to the suspected intervention, but that could readily have been produced by a number of other factors. · Not Related: The adverse event is clearly not related to the investigational agent/procedure - i.e. another cause of the event is most plausible; and/or a clinically plausible temporal sequence is inconsistent with the onset of the event and the study intervention and/or a causal relationship is considered biologically implausible.

Adverse Event Severity

· Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type causing no loss of time from normal activities. Symptoms do not require therapy or a medical evaluation; signs and symptoms are transient. · Moderate: Events introduce a low level of inconvenience or concern to the participant and may interfere with daily activities, but are usually improved by simple therapeutic measures; moderate experiences may cause some interference with functioning · Severe: Events interrupt the participant's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE.