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This is the List of the ‘Clinical Research Associate Interview Questions’ it may helpful what kinds of questions while facing the Clinical Associate Job Interview or CRA interview. This is questions will be helpful for clinical research coordinator jobs as well as Pharmacovigilance interviews as well.Be Prepared well with this Interview questions.
What is informed consent?
Before Partifipating to take whether to take part in clinical trial or not,the first mandatory point is to take permission informed consent is the method of discovering crucial information about a clinical trial. The provision of information for the participants is also a continuous process during the study.
The Complete Clinical trial explain by Clinical Research Associates or CRA’s, Doctors, Nurses and the Medical staff the details of the study to help someone decide whether to participate or not. If the participant’s native language is not English, translation assistance can also be provided.
The research team also offers an informed consent document that contains specifics of the project, such as its purpose, duration, required procedures, and key contacts.
What is Primary and Secondary End points
Primary end point are the specific event that the study is designed to assess the effect of the drugs upon. It answers the most important question of the clinical trial. They are also called primary outcome measure.
Secondary end point are additional events of interest, but which the study is not specifically powered to assess. They are also knows as Secondary outcome measures.
What is treatment arm?
A group of subjects that receives a specific intervention/treatment, or no intervention in clinical trial. Group of subjects who receive treatment, are called treatment arm.
Active comparator arm:Group of subjects receive standard treatment
Placebo comparator arm: Group of subjects receive standard treatment
Sham comparator arm: group of subjects receive same procedure or device without active component or process. (It is like Placebo comparator arm but for medical devices and procedure)
What is Surrogate end point?
As per National Cancer Institute: “In clinical trials, an indicator or sign used in place of another to tell if a treatment works. Surrogate endpoints include a shrinking tumor or lower biomarker levels.”
Alternatively of stronger metrics such as longer lifespan or better quality of life, they could be used as the test results can be assessed earlier.
Using surrogate endpoints in clinical trials that allow for earlier approval of new drugs for treating severe or life-threatening diseases , such as cancer. Surrogate endpoints are not necessarily accurate markers or measures of how well a treatment operates.
What do you understand by Randomization?
As per the National Cancer Institute “In research, the process by which participants in clinical trials are assigned by chance to separate groups that are given different treatments or other interventions.
Neither the researcher nor the patient chooses what medication or intervention they should receive.
Using chance of assigning people to groups means that the results of the care or intervention obtained by the participants can be more equally compared.
What do you know about ICH and GCP?
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use is the full form of ICH.
Guidelines provided by ICH can be divided into 4 categories: Quality (Q), Safety (S), Efficacy (E) and multidisciplinary guidelines (M).
These guidelines help to harmonize technical guidelines which are being followed by many countries for drug registration.
Read about missing and member countries: https://www.ich.org.
What are the different types of clinical studies?
There are two main type of trials: Observational clinical trial and interventional clinical trial
“Interventional clinical study is performed with the purpose of studying or representing clinical or pharmacological properties of drugs/devices, their side effects and to establish their efficacy or safety.”
Whereas observational studies,are those studies where intervention is not given (treatment, drug, surgery). There are many type of clinical studies and you can read about each study in detail here: (case report or case series, ecologic, cross-sectional (prevalence study), case-control and cohort studies)
What are the Phases of clinical trials?
Clinical trials are conducted in four phases. Each Trial have different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in very small group of population (20-80) for the first time in order to evaluate its safety, determine a safe dosage range, and to identify side effects. (Maximum tolerated dose assessment)
In Phase II trials, the experimental study drug or treatment is given to a larger group of population (100-300) to see if it is effective and to further evaluate its safety. (Efficacy)
In Phase III trials, the experimental study drug or treatment is given to large groups of population (1,000-3,000) to validate its effectiveness, monitor side effects, compare it to commonly used treatments, and assemble information that will allow the experimental drug or treatment to be used very safely. (effectiveness)
In Phase IV trials, post-marketing studies describe additional information including the drug’s risks, benefits, and best possible use. (Post Marketing surveillance)
What is “expanded access”?
Expanded access is a means by which manufacturers, under certain circumstances, make investigational new drugs available to treat a patient(s) with a serious illness or condition that can not participate in a controlled clinical trial.Most human use of the investigational new drugs takes place in controlled clinical trials conducted to measure the safety and efficacy of the new drugs.
What do you know about single and double blind studies?
In a single blind study, the subjects in the clinical trial do not know if they are receiving the placebo or the real treatment. where as in double blind clinical trial , both the subjects and the investigator do not know which group got the placebo and which got the experimental treatment.
What are Triple Blind Studies?
In triple blind studies, Subjects, Investigator and individuals who are responsible for analysis the outcomes are blinded. You can find the example of triple blind study here:
What is Open label trials?
Open label trials are those trials where no blinding is done.Subjects and Principle investigator and outcome analysis team knows about treatment and placebo group.
What is Placebo?
“A placebo is anything that seems to be a “real” medical treatment — but it doesn’t. It might be a pill, a shot, or some other type of “fake” treatment. All placebos have one thing in common is that they do not contain an active substance meant to affect health.
Normally, the person getting a placebo doesn’t know for sure that the treatment isn’t real.
The placebo is often in the form of a “sugar pill,” but it may also be an injection, a liquid, or even a procedure. This is intended to act like a true cure, but it does not affect the disease directly.
Clinical trial protocol describes the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials.”
In simple words, We can say clinical trial protocol tells us “how to conduct scientifically sound, reliable and ethically compliance trials”
“Investigator Brochure enables investigators (Doctor at hospital) conducting clinical studies to know the risks and benefits associated with an investigational product.”
The regulatory agency of USA is FDA which has two bodies: CBER and CDER.
CBER stands for Centre for biological evolution and Research and CDER stands for Centre for drug evaluation and research. CBER agency deals with biological product whereas CDER deals with drugs and biological both. In general the drug (chemical) approval process in US can be divided into four parts, they are:
1.Supplemental new drug application
2.Abbreviated new drug application
4. New drug application
What is SAP
SAP (Statistical Analysis Plan) is the document that contains detailed information about the statistical methods and the study objectives to help in the production of the Clinical Study Report (CSR) that includes figures, summary tables, and subject data listings for Protocol.Documentation of the program variables and algorithms which would be used to produce descriptive statistics and statistical analysis.
What is LOCF?
Pharmaceutical companies spend numerous months to conduct longitudinal studies on the human subject. It is impractical to expect patients to keep timely visit over such a long period of time.In spite of all the efforts, patient data are not collected for some and these become missing values in a SAS data set soon.
Explain the role of clinical research coordinator?
In general, clinical research coordinator works as an assistant to Principle investigator (PI). CRC helps in taking the informed consent forms, enter the the in the eDC, followup with the subjects for site visits, respond to data management and clinical research associate queries. They are also involved in budget planning and management of budgets for the study and financial payments.
You can also explore the role of CRA here, which is similar question:
“Efficacy = best possible results for a particular intervention, under perfect conditions;
“Effectiveness = most likely results for a particular intervention under pragmatic or ‘real-life’ conditions (taking into account compliance, dropouts, withdrawals, the learning curve for surgical interventions, etc.)
Benefits include: Playing an active role in one’s health care, having access to medications that may not be accessible for a significant period of time, and supporting people by engaging in the study so that the drug can eventually be accepted and made readily available.
Risks include: Participation in the clinical trial may involve some risks that doctor will explain in more detail. These risks may include:
• Side-effects that are known and those that have not yet been identified;
• risks associated with the study procedures;
• the experimental treatment may be not be effective or less effective than the current standard;
• the experimental treatment may not work for all patient.
Prospective: Looking ahead, starting before therapy has started.
Randomized: Patients are randomly assigned to obtain the alternative or experimental treatment ( e.g., standard of care or placebo)
Double-blind: Neither patients nor research personnel know which participants receive the experimental drug and which participants receive a placebo or normal treatment.
Controlled: One group of the patients will be given an experimental drug or treatment, while a second group is given either the standard treatment for the illness or a placebo.
Who Sponsors A Clinical Trial?
Clinical trials can be sponsored or funded by a variety of the organizations or individuals including physicians, medical institutions, voluntary groups, foundations, and pharmaceutical companies, in addition to the government agencies such as the National Institutes of Health (NIH), the Department of Defence (DOD), Human Health and Services (HHS), and Department of Veteran’s Affairs (VA).
What is the scope of clinical research in India?
The Scope of Clinical Research depends on the growth of the Medical / Pharmaceutical Industry. And in India, this growth is immense, and the pace is rising. Drug discovery involves designing new drugs, and after identifying a prospective article, the drug development process takes place. Action, safety, use, formulation, quality control, storage, packaging, and marketing are few of the other stages associated with the drug development process.
Clinical research is a subcategory of medical research that involves studies with humans or human-related data. Medical research is concentrating on unlocking the basis of medical treatment by using a variety of approaches.
Blinding is a procedure in which one or more parties in a trial are unaware of which participants in the treatment arms were assigned, that is, what treatment was received.
Blinding is an essential characteristic of any study performed to prevent and eliminate conscious or implicit bias in planning and conducting a clinical trial.
A clinical trial is called a single blind if only one group, usually the patients, are blinded. If both the participants and study staff are blinded, it is known as double blind study. Triple blinded experiments also expand the data analysts to blind.
A trial in which no blinding is used and the treatment groups are known to all parties is called open label or unblinded.
Explain Clinical Trials ?
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 licence 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.
Why 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 Do You Understand By Crt?
CRT means Case Report Tabulation. CRT’s are sent to the FDA whenever a pharmaceutical company is submitting an NDA.
What Are All The Procs You Know?
I know about many procedures like proc sort, proc report, proc format etc. I have generated the list report using the proc report; in this procedure I used subjid as order variable and sbd, trt_grp, dbd as display variables.
As a CRA you can develop within the hierarchy of the clinical research department, or make a switch to, for example, the medical department into positions like Medical Science Liaison (MSL) or Medical Adviser.