215 Terms Commonly Used in Clinical Research
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With a robust background in clinical research, I, Anıl Goktas, have honed my skills across various therapeutic areas and trial phases. As a Clinical Research Associate (CRA), I have played a pivotal role in numerous high-profile studies, particularly in oncology, cardiology, and autoimmune diseases.
My journey in clinical research began at Medex SMO, where I served as a Site Coordinator, managing Phase III trials with precision. Over the years, I advanced to the role of CRA, contributing to the success of pivotal Phase II and III trials at esteemed organizations like Medex CRO, IQVIA, and Ascot Science.
Currently, as a CRA 2 at Medex CRO, I am deeply involved in cutting-edge CAR-T therapy studies and groundbreaking oncology research. My expertise ensures compliance with rigorous regulatory standards, maintaining the highest quality of clinical data.
Passionate about advancing medical science, I continue to engage in transformative research that aims to improve patient outcomes and contribute to the development of innovative treatments.
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PHASE 1
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2022-2023: DC25-1A CAR-T (Phase I/IIa) Multiple Myeloma - Clinical Research Associate (CRA)
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2023-Present: MG-001 (Phase Ib/II) - Clinical Research Associate 2
PHASE 3
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2023-Present: PZN-127-03 (Phase III) - Clinical Research Associate 2
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2023-2023: Horizon01 – Lung Cancer (Phase III) - Clinical Research Associate 2
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2023-2023: INOVA 120-WO41554 Breast Cancer (Phase III) - Clinical Research Associate 2
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2021-2023: I6T-MC-AMAM - Crohn Disease (Phase III) - Site Coordinator
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2021-2023: I6T-MC-AMAX - Crohn Disease (Phase III) - Site Coordinator
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2021-2023: GA29145 (Phase III) - Site Coordinator
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2021-2023: APD334-303 (Phase III) - Site Coordinator
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2021-2022: APD334-302 (Phase III) - Site Coordinator
PHASE 2
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2024-Present: DC08-SLE-001 CAR-T (Phase IIa) - Clinical Research Associate 2
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2023-2024: Intercept 747-214 (Phase IIa) - Clinical Research Associate 2
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2022-2023: DC-08 CAR-T (Phase II) - Clinical Research Associate (CRA)
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2020-2021: B7981007 (Phase II) - Site Coordinator
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2020-2021: B7981005 (Phase II) - Site Coordinator
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2021-2023: APD334-202 (Phase II) - Site Coordinator
PHASE 3
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2021-2022: 261203 (Phase III) - Site Coordinator
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2021-2023: HS0003 (Phase III) - Site Coordinator
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2021-2023: TCH-306 (Phase III) - Site Coordinator
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2021-2021: HS-18-633 (Phase III) - Site Coordinator
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2021-2021: HS-19-647 (Phase III) - Site Coordinator
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2020-2023: C3601002 (Phase III) - Site Coordinator
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2020-2022: CT-P13_3.8 (Phase III) - Site Coordinator
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2019-2023: AR-301 (Phase III) - Site Coordinator
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2018-2021: ALX0681-C301 (HERCULES) (Phase III) - Site Coordinator
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2023-Present: MG-001 (Phase Ib/II) - Clinical Research Associate 2
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What are the future trends in clinical research?Advancements in personalized medicine, AI, and digital health technologies are shaping the future of clinical research.
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How are vulnerable populations protected in clinical research?Extra precautions are taken to ensure that vulnerable populations, such as the elderly or those with cognitive impairments, are protected.
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What is compassionate use in clinical research?Compassionate use allows patients with serious conditions to access experimental treatments outside of clinical trials.
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How are pediatric participants involved in research?Special ethical considerations and parental consent are required for involving children in clinical research.
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How does globalization affect clinical research?Globalization leads to the conduct of multinational studies, increasing diversity and relevance of the results.
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Why is clinical research conducted?The purpose is to develop new treatments, improve existing therapies, and understand diseases better.
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What is the goal of clinical research?The goal is to discover new treatment methods, enhance the understanding of diseases, and improve the effectiveness of current treatments.
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Who can participate in clinical research?Participation depends on specific criteria, including age, health status, and the type of disease being studied.
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What is clinical research?Clinical research involves scientific studies that assess the safety and efficacy of new medical treatments, drugs, or devices in humans.
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What are the phases of clinical research?Clinical research typically consists of four phases: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (confirmation), and Phase 4 (post-marketing surveillance).
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What are the benefits of participating in clinical research?Participants may gain early access to new treatments, receive personalized care, and contribute to medical science.
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What are the risks of participating in clinical research?Potential risks include side effects, ineffectiveness of the treatment, and unknown risks.
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Do participants receive compensation?In some studies, participants may be compensated for travel and lodging expenses, or they may receive payment.
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Is participation in clinical research voluntary?Yes, participation is entirely voluntary, and participants can withdraw at any time.
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Is it difficult to participate in clinical research?Participation depends on meeting specific eligibility criteria, and suitable volunteers are selected accordingly.
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How is confidentiality maintained in clinical research?Participants' personal information is anonymized and used only for research purposes.
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What is informed consent?Informed consent is the process by which participants are fully informed about the risks and benefits before joining a study.
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How is the safety of clinical research ensured?Studies are closely monitored by ethical committees to ensure participants' safety.
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How are ethical principles applied in clinical research?Research is conducted according to ethical principles, including respect for human rights, informed consent, and participant safety.
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What is a placebo, and how is it used?A placebo is an inactive treatment used as a control to compare the effects of the actual treatment being studied.
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What are randomized controlled trials (RCTs)?Participants are randomly assigned to different groups to compare the effects of various treatments.
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What are open-label studies?In open-label studies, both the participants and the researchers know which treatment is being administered.
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What are observational studies?These studies monitor participants' health without intervening with treatments.
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What are interventional studies?Interventional studies involve applying new treatments or drugs to participants.
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What are blind studies?In blind studies, either the participants (single-blind) or both the participants and researchers (double-blind) do not know which treatment is being given.
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How does the approval process for research work?Every study must be approved by ethical committees and regulatory authorities before it can begin.
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How are research results reported?Results are published in scientific journals and shared with regulatory bodies.
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Who regulates clinical research?Clinical research is regulated by local and international authorities.
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What happens if a clinical research study fails?Failed studies are evaluated to understand why they failed, and they may not be repeated.
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How are side effects managed in clinical research?All side effects are carefully monitored, and treatment may be stopped if necessary.
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What responsibilities do participants have?They are responsible for following instructions and cooperating with the research team.
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What obligations do participants have?Participants must follow the study protocol and provide accurate information about their health.
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What information is provided to participants?Participants are informed about the study’s purpose, procedures, potential risks, and benefits.
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Can participants withdraw from a study?Yes, participants have the right to withdraw from the study at any time.
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Can research results be incorrect?Incorrect results are rare but can happen if the study design is flawed or if there are biases.
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What is the impact of clinical research on public health?It leads to the development of new treatments, improves healthcare, and contributes to the overall well-being of society.
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What happens after a successful clinical research study?Successful studies may lead to the approval and market release of new treatment methods.
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Are research results disclosed to the public?Yes, results are usually disclosed through scientific publications or regulatory reports.
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How long does it take to obtain research results?Results vary depending on the type and phase of the research and can take years.
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How long do clinical studies last?The duration varies based on the study’s purpose and can range from several months to several years.
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Who prepares the research protocol?The research team prepares it, and it must be approved by ethical committees.
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What tools are used in clinical research?Medical devices, laboratory tests, imaging techniques, and surveys are common tools used.
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What types of data are collected during research?Data on participants' health status, response to treatment, and side effects are collected.
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What is a clinical research protocol?A protocol is a detailed plan that outlines how the study will be conducted.
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Who is involved in the clinical research team?The team typically includes researchers, doctors, nurses, ethical committees, and data analysts.
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What is the cost of clinical research?Costs vary depending on the study’s scope, the number of participants, and the technology used.
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How is research oversight conducted?Oversight is provided by regulatory authorities and independent monitors to ensure compliance with protocols.
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How is the success of clinical research measured?Success is measured by the treatment's efficacy, safety, and achievement of the study’s objectives.
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How is clinical research funded?Research is usually funded by pharmaceutical companies, government grants, or academic institutions.