Clinical data management (CDM) is performed by clinical data managers. They conduct clinical research that results in high-quality, statistically sound data and reliable clinical trials. The primary role of clinical data managers is to ascertain that the collection, availability, and integration of data are of acceptable cost and quality.
Clinical data management has massive career development, and the people in this position experience tremendous career development. You should aspire for this position and experience the advantages of this massive career development. Here are clinical data management interview questions and answers you need to practice in order to pass your next interview.
1. What Is Meant by Masking or Blinding?
In masking or blinding, a researcher hides the details from the research subject, even if the research subject is receiving a placebo, investigational product, or current standard treatment. There are two types of binding: Single and double binding. Single binding is where the patient is unaware of the treatment while double binding, neither the patient nor the researcher knows the treatment. Masking or binding helps eliminate biases in the treatment process that the researcher is investigating.
2. What is Placebo?
Placebo refers to a powder, pill, or liquid that has no active ingredients. Placebo helps researchers to isolate the study treatment effect. They are a significant part of clinical studies. They give researchers a comparison point for new therapies to prove if they are effective and safe. Additionally, they provide the clinical data managers with the evidence they need to use to regulatory bodies to approve a new drug.
3. What is a Patient File? What Information Does It Contain?
A patient’s file contains the medical and treatment history of the patient and demographic data. It can also have paper records or a combination of both computer and paper records. The patient file is significant for the continuity care for the patients. It’s also essential for defending a complaint or clinical negligence claim.
4. Define the Different Phases of Clinical Trials
There are four major clinical trial phases and include:
- Phase I: Human pharmacology trials
- Phase II: Therapeutic exploratory trials
- Phase III: Therapeutic confirmatory trials
- Phase IV: Post-marketing surveillance trials
Phase I trials take one or more years and tests one or more combinations of objectives. It also includes MAD, SAD, and food effect studies. Phase II trials last for one or two years and test the effective dose and the dosing regimen. Phase III trials range from 3 to 5 years and are called randomized, controlled, and multicenter trials and are significant for the approval of drugs. Phase IV trials are those that the regulatory authorities require the manufacturer to take for competitiveness.
5. What are Orphan Trials?
Orphan trials are tests that the clinical manager performs on drugs designed to treat diseases that affect less than 200,000 people. They carry out the test on a small number of extremely sick people and see if the drugs work immediately.
6. What is Bioequivalence?
Bioequivalence is where the clinical manager evaluates the anticipated in-vivo biological equivalence of two proprietary preparation of drugs. Two drugs are bioequivalent if they are for the same intent and purpose. Bioequivalence is very significant in the development of pharmaceuticals. It matches the set standards to ensure the therapeutic performance of the drug that has undergone several processes from manufacturing until it reached the market is good.
7. What Causes the Different Phases of Trials to Fail?
Phase I trial fails when the pre-clinical model isn’t equivalent to human behavior, or there is insufficient pre-clinical data or extra toxic drug in humans. It can also fail when there is a shift in drug formulation from pre-clinical testing to clinical testing. Phase II and III trial fails due to drug interaction, drug-disease interaction, economic, infrequent ADRs and insufficient effectiveness.
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8. What Does the Declaration of Helsinki State?
The Helsinki declaration describes the rules for research, clinical care, and non-therapeutic research. The rules are that:
- Risk should never outdo benefits
- Only medically scientifically qualified individuals should conduct research
- Researchers should base research on human beings on the results from animal and laboratory experiments
- Independent committee should review research protocols before initiation
9. What are the Objectives of Ich?
The primary goal of Ich is to give recommendations on various ways to attain greater harmonization in the application and interpretation of technical guidelines and requirements for product registration. It aims at reducing the need to duplicate the tests conducted during the research and development of new medicines.
10. What are the Participants of Pharmacovigilance?
The participants include patients, doctors, nurses, pharmaceutical companies, and importing and distributing companies. The patients are the core consumers of the medicine. Doctors, nurses, and other health care practitioners are responsible for monitoring the safety standards of the medicines.
11. What is the Importance of Pharmacovigilance?
Pharmacovigilance is important in limiting the illegal sale of medicines and drugs of abuse over the internet. It also curbs increased self-medication, and increased use of traditional medication outside the borders of traditional practices use. Besides, pharmacovigilance reduces the increased use of different system medications with the potential for drug interaction.
12. What is Ib?
The investigator brochure (Ib) is a primary document which the clinical manager needs for clinical trials concerning FDA regulations. Ib contains:
- The formulation and description of the drug substance.
- Summary of the toxicological and pharmacological effects.
- Summary of information relating to its safety and effectiveness in humans
- Describes the adverse reaction and possible risks a patient should expect and the investigator’s precautions.
13. What is Protocol Document?
A protocol document defines the objectives, methodology, design, statistical considerations, and clinical trial organization. It permits researchers at multiple locations to research in the same manner to allow a combination of their data as if they did the study in the same location. Moreover, the protocol document gives the research administrators and the local researchers a common reference document for their roles during the trial.
14. What is an Audit Trail?
The audit trail refers to the data that shows the study was carried out following the accepted protocols. It mentions who, why, and when the changes in the data take place. It can also be referred to as documentation that permits the reconstruction of the course of events, according to the Society for Clinical Data Management (SCDM). Audit trails are vital in ensuring visibility in developing a system to an accurate review of the historical security and ensures the information is secure and can’t get in the hands of unauthorized personnel.
15. Describe the Process of Discrepancy Resolution
The discrepancy management team resolves the discrepancy resolution using Data Clarification Form (CDF) or the Data Query Form (DQF). The team generates DCF and sends it to the site investigator for clarification. The investigator receives the corrected values as a response to the CDF and updates them in the database. Lastly, the investigator locks the database to prevent further unauthorized modifications after he has crosschecked the data for errors.
16. What Are the Roles of Clinical Data Manager?
A clinical data manager collects data from numerous medical research projects like clinical and pharmaceutical trials. He/she collaborates with the team members to ensure they collect data, manage and give clear reports that are accurate and secure.
17. What Are the Qualities That a Clinical Data Manager Should Possess to Be Effective
An excellent clinical data manager should have excellent written and verbal communication skills to communicate effectively with the other researchers and record the data accurately. Additionally, he needs to have computer skills, database skills, and project management skills to ensure the project runs smoothly and accomplishes its objectives.
18. How Do You Stay Motivated at Work?
I value people’s health, and I love it when people get clinically proven medicines that effectively improve their health. Clinical data management is a very significant phase in clinical research and results in high-quality, statistical, sound data that is reliable from clinical trials. I get motivated to work hard to reduce the time from drug development to marketing to ensure those ailing can get the medications on time.
19. Describe Your Daily Routine as a Clinical Data Manager
I start my day by processing clinical data such as receipts, verifications, entry, and filing of information. I oversee the work that the data management project staff handle and develop data questions based on validation checks or errors and omissions that I identified during data entry and resolve the problems.
20. Describe a Time You Failed in This Role and The Lessons You Learned
As a clinical data manager, I had poor trials and inconsistencies with my endpoints during my first project. The poor trials were because I didn’t plan effectively on goals for the entire development phase, including post-market. Additionally, I involved a biostatistician and consultant statistician towards the end of the project and not from the initial stage. However, I learned to plan effectively and involve the right biostatistician and the consultant statistician from the onset of the project as they play a critical role in protocol development, monitoring and reporting, and data management.
21. Why are You Interested in This Role?
I have always admired working in your company. I thus follow all your social media handles and read all your posts. I know all the rules and regulations of your company, and I like the way you manage the company and how you support your employees. I want to be part of your team, and I promise to work smart and collaborate with my team members to ensure the success of the projects we handle.
22. What Challenges Did You Face During Your Last Role? How Did You Handle It?
The major challenge was the shortage of data for testing. It’s very dangerous to test with real-time data, and it’s against privacy regulations. Our company had insufficient realistic information that we needed for testing purposes. The shortage led to the delay in the production of the medicine. Thus, I talked to the company manager, and we purchased a reliable automated software for test data generation that helped us create fictitious test data credentials effectively.
23. Describe Briefly About Your Clinical Data Management Experience
I have over fifteen years of experience as a clinical data manager. I started working as a clinical manager in a hospital in town where I worked for six years, then got a transfer to work in their new branch in a new town. I have gained numerous skills such as project management skills, database skills, computer skills, and excellent communication skills throughout my working experience. I am conversant with all the methods of collecting data, preparing, and distributing while following the legal legislations.
24. What Kind of Strategy and Mindset is Required for This Role?
A clinical data manager needs to have excellent project management and communication skills to ensure the projects succeed. He/she should have a positive mindset and be willing to collaborate with team members and learn from them. He/she should set clear objectives to determine the process, governance tools, etc. The clinical data manager should also create strong data processors such as collection process, preparation, storage, and data distribution. Additionally, he/she should determine the right technology to store the data and ensure safety.
25. What is the Biggest Challenge You Foresee in This Job?
The biggest challenge is usually a lack of cooperation from team members, which can cause a testing project to fail. That can lead to data breaches, and also unintended data which could be costly. The malicious activities could result in a financial dent in an organization and lead to serious legal implications. However, various data masking and de-identification solutions have come up to help clinical data managers build safe test environments and comply with the regulations. Thus, I anticipate no challenge while working in your organization.
Clinical data management is a great role with a lot of advantages. According to PayScale, the salary of a clinical data manager averages around $77,401 per year. You can’t afford to miss an opportunity with such an amazing salary. Study and practice these interview questions and answers to be adequately prepared for your clinical data management interview.