Clinical Research Associate Interview Questions and Answers for Freshers and Experienced

What is a clinical trial?

Although clinical trials have many different definitions, they are typically thought of as biomedical or health-related research investigations in humans that adhere to a pre-established methodology. Both interventional and observational study types can be found on ClinicalTrials.gov. Interventional studies are ones in which the researcher randomly assigns research participants to receive a treatment or another type of intervention, and then records the results. Observational studies are ones in which participants are watched and the researchers measure the outcomes.

What is informed consent?

Knowing the essential information about a clinical trial before deciding whether or not to join is the process of informed consent. In addition, providing participants with information is a continuous process during the whole study. The doctors and nurses involved in the trial lay out the specifics of the study so that anyone considering participating can make an informed decision. If English is not the participant's first language, translation support can be offered. The research team then presents an informed consent document that contains information about the study, including its goal, duration, necessary steps, and essential contacts. The informed consent statement explains risks and potential benefits. The decision to sign the document is then up to the individual. A contract is not what informed consent is, and the participant may withdraw from the trial at any time.

What are side effects and adverse reactions?

Any unintended behaviours or consequences of an experimental medicine or treatment are referred to as side effects. Headache, nausea, hair loss, rashes on the skin, and other bodily issues are examples of negative or unpleasant consequences. The potential negative effects of experimental therapies must be assessed both immediately and over time.

How is the safety of the participant protected?

Clinical trials are subject to the same ethical and legal standards that apply to medical practise. Additionally, with built-in safeguards to protect the participants, the majority of clinical research is governed by federal regulations. The trial adheres to a strictly monitored protocol, a study plan outlining the procedures that will be used. As a clinical study advances, researchers publish the trial's findings to various government bodies, medical publications, and scientific conferences. The names of specific individuals won't be revealed or included in these reports (See Confidentiality Regarding Trial Participants).

What should people consider before participating in a trial?

People should be as informed as possible about the clinical study and at ease asking the members of the medical staff about it, the level of care anticipated during a trial, and the trial's cost. The participant may find it useful to discuss the following issues with the medical staff. The informed consent document contains some of the responses to these queries.

 

 

Does a participant continue to work with a primary health care provider while in a trial?

Yes. The majority of clinical trials offer transient therapies for a specific disease or condition, but they do not offer comprehensive or extended primary care. Additionally, the participant may make sure that other therapies or drugs won't clash with the protocol by having the healthcare professional collaborate with the study team.

Can a participant leave a clinical trial after it has begun?

Yes. Anytime throughout a clinical trial, a person may withdraw. The participant must inform the research staff of their decision to withdraw from the experiment, along with their reasons.

Where do the ideas for trials come from?

Researchers typically have ideas for clinical studies. The experimental medicines with the most encouraging laboratory results are pushed into clinical trials after researchers examine novel therapies or procedures in the laboratory and in animal studies. An experimental treatment's hazards and potential effectiveness are all learned more and more during a study.

Who sponsors clinical trials?

In addition to federal organisations like the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs, clinical trials are sponsored or funded by a variety of organisations or individuals, including doctors, medical institutions, foundations, volunteer groups, and pharmaceutical companies (VA). Trials may be held in a number of settings, including medical facilities, academic institutions, offices of physicians, and neighbourhood clinics.

What is a protocol?

All clinical trials are based on a protocol, which is a research strategy. The strategy is specifically created to address certain research issues as well as protect the participants' health. A protocol specifies the trial's eligibility criteria, the timetable for testing, procedures, drugs, and doses, as well as the scope of the research. The research team periodically checks in with clinical trial participants who are following the protocol to evaluate their health and assess the efficacy and safety of their medication.

What is a placebo?

An ineffective pill, liquid, or powder known as a placebo has no therapeutic benefit. To determine if an experimental treatment is beneficial, placebo controls are frequently compared in clinical studies. In certain research, a placebo will be administered to study participants in the control group in place of an active medication or an experimental therapy.

What is a control or control group?

The benchmark by which experimental observations are assessed is a control. In many clinical studies, one patient group may get an experimental medication or therapy, while the control group will receive either the conventional care for the patient's condition or a placebo.

What are the different types of clinical trials?

• Treatment studies investigate novel medication combinations, surgical techniques, or radiation therapy protocols.

• Prevention studies explore find more effective strategies to stave against illness in those who have never had it or to stop a disease from coming back. These strategies may consist of drugs, vaccinations, vitamins, minerals, or lifestyle modifications.

• Diagnostic trials are carried out to discover improved methods or tests for a certain disease or condition's diagnosis.

• Screening studies examine the most effective method for identifying certain illnesses or medical issues.

• Quality of Life studies, also known as supportive care trials, examine how to increase comfort and quality of life for people who have a chronic condition.

What are the phases of clinical trials?

• Phases of clinical trials are carried out. Each phase's trials serve a particular goal and aid research into a different area of study:
• In Phase I trials, scientists test a new medication or therapy on a small population (20–80) in order to assess its safety, establish a safe dose range, and discover any negative effects.
•  In Phase II trials, the experimental research medication or therapy is administered to a wider population (100–300) in order to determine its efficacy and further assess its safety.
•  In Phase III trials, the experimental research medication or therapy is administered to large groups of individuals (1,000–3,000) in order to validate its efficacy, track adverse effects, evaluate it against conventional therapies, and gather data that will allow the experimental drug or treatment to be used safely.

      •      Post-marketing studies in Phase IV trials provide additional data, such as the drug's dangers, advantages, and best practises.

What is “expanded access”?

Expanded access is a strategy used by manufacturers to make experimental new medications available, under specific conditions, to treat patients with severe illnesses who are unable to take part in controlled clinical trials.

Controlled clinical trials are used to evaluate the safety and effectiveness of experimental new medications on humans. The cornerstone for the drug marketing application is the data from these studies, which are used to assess a medicine's safety and efficacy. Because of age, other health issues, or other circumstances, people occasionally may not meet the requirements for these controlled studies or are otherwise unable to participate in them (e.g., a patient may not live sufficiently close to a clinical trial site).

FDA regulations permit manufacturers of such drugs to grant patients access to the drug under specific circumstances, known as "expanded access," for those patients who are unable to take part in a clinical trial of an investigational drug but who have a serious disease or condition that may benefit from treatment with the drug. If a patient does not have any other acceptable treatment choices (such as an authorised medicine that might be used to treat the patient's disease or condition), the drug cannot subject them to unacceptable risks considering the severity of the ailment that has to be treated. The drug's maker must be willing to offer broader access to it. The main goal of extended access is to treat a patient's illness or condition, rather than to collect data about the study drug.

Pharmaceutical companies provide some experimental medications through extended access programmes that are listed in ClinicalTrials.gov for use in treating patients. Review the protocol eligibility requirements and call the Contact Information number if you or a loved one is interested in receiving treatment with an experimental medicine under an extended access procedure that is published on ClinicalTrials.gov. If ClinicalTrials.gov does not mention an expanded access protocol, you or your healthcare practitioner may speak with a manufacturer of an experimental medicine directly to learn more about expanded access programmes.

1. Describe the phases of clinical trials?

Ans: The four phases of the clinical trials are as follows:

Phase 1: A novel medication or therapy is tested on a limited (20–80 person) population to determine its safety.

Phase 2: To determine if the experimental medication or treatment is successful in treating a certain condition, it is administered to a sizable population (100–300).

Phase 3: A sizable population (1000–3000) of individuals receives the experimental medication or therapy in order to assess its efficacy, track any adverse effects, and contrast it with standard medical care.

Phase 4: The post-marketing research on the drug's risks and advantages is part of the four-phase study.

2. Describe the validation procedure? How would you perform the validation for TLG as well as analysis data set?

Ans: The output of the SAS programme produced by the source programmer is examined using a validation technique. The software is written by the validator, who also produces the output. The programme is deemed to be legitimate if this output matches the output produced by the SAS programmer. This validation may be done for TLG by manually reviewing the output, and it can be done for the analytical data set by using PROC COMPARE.

3. How would you perform the validation for the listing, which has 400 pages?

Ans: Manual validation cannot be done for listings with 400 pages or more. To do this, we first use PROC RTF to convert the listing in the data sets, and then PROC COMPARE to compare the results.

4. Can you use PROC COMPARE to validate listings? Why?

Ans: Yes, we may use PROC COMPARE to validate the listing as it is impossible to manually examine them if there are numerous items (pages) in the listings. Therefore, in this circumstance, PROC COMPARE is used to validate the listings.

5. How would you generate tables, listings and graphs?

Ans: By utilising the PROC REPORT, we are able to produce the listings. The same procedures, including PROC FREQ, PROC MEANS, PROC TRANSPOSE, and PROC REPORT, may be used to construct tables. Graph generation would be done using proc Gplot, etc.

6. How many tables can you create in a day?

Ans: Actually it depends on the complexity of the tables if there are same type of tables then, we can create 1-2-3 tables in a day.

7. What are all the PROCS have you used in your experience?

Ans: I have employed several processes, including proc format, proc sort, and proc report. To create the list report, I used the proc report method. I utilised the order variable subjid and the display variables trt grp, sbd, and dbd.

8. Describe the data sets you have come across in your life?

Ans: I have worked with demographic, adverse event, laboratory, analysis and other data sets.

9. How would you submit the docs to FDA? Who will submit the docs?

Ans: We can submit the docs to FDA by e-submission. Docs can be submitted to FDA using define.pdf or define.Xml formats. In this doc we have the documentation about macros and program and E-records also. Statistician or project manager will submit this doc to FDA.

10. What are the docs do you submit to FDA?

Ans: We submit ISS and ISE documents to FDA