data/clinical_faq.json

[
  {
    "question": "What is a clinical trial?",
    "answer": "A clinical trial is a research study in which volunteers receive interventions to evaluate their effects on health outcomes."
  },
  {
    "question": "What are the phases of clinical trials?",
    "answer": "Phase I tests safety in small groups. Phase II tests efficacy and side effects. Phase III compares with standard treatments in large populations. Phase IV monitors long-term effects after approval."
  },
  {
    "question": "What is informed consent?",
    "answer": "Informed consent is a process in which potential participants are educated about the purpose, procedures, risks, and benefits before agreeing to participate."
  },
  {
    "question": "What is a placebo?",
    "answer": "A placebo is an inactive substance or treatment designed to resemble the intervention being tested, used to measure true treatment effects."
  },
  {
    "question": "What is randomization?",
    "answer": "Randomization is the process of assigning participants to different trial arms by chance, reducing bias."
  },
  {
    "question": "What is a CRO?",
    "answer": "A Contract Research Organization (CRO) is a company that provides support to pharmaceutical, biotech, and medical device companies in the form of outsourced research services."
  },
  {
    "question": "What is an SAE?",
    "answer": "A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or results in significant disability."
  },
  {
    "question": "What is a DSMB?",
    "answer": "A Data Safety Monitoring Board (DSMB) is an independent group of experts that monitors safety and efficacy data during a clinical trial."
  },
  {
    "question": "Who regulates clinical trials in the US?",
    "answer": "The Food and Drug Administration (FDA) regulates clinical trials of drugs and devices in the US."
  },
  {
    "question": "Who regulates clinical trials in Europe?",
    "answer": "The European Medicines Agency (EMA) oversees the scientific evaluation, supervision, and safety monitoring of medicines in the EU."
  },
  {
    "question": "Who regulates clinical trials in India?",
    "answer": "The Central Drugs Standard Control Organization (CDSCO) regulates clinical trials in India."
  },
  {
    "question": "What is Good Clinical Practice (GCP)?",
    "answer": "Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials."
  },
  {
    "question": "What is trial monitoring?",
    "answer": "Monitoring ensures that the rights and well-being of participants are protected, data are accurate, and the trial complies with protocols and regulations."
  },
  {
    "question": "What is protocol deviation?",
    "answer": "A protocol deviation is an unplanned departure from the approved trial procedures, potentially affecting participant safety or data integrity."
  },
  {
    "question": "What is efficacy?",
    "answer": "Efficacy refers to how well a treatment works under controlled conditions in a clinical trial."
  },
  {
    "question": "What is safety reporting?",
    "answer": "Safety reporting involves documenting and submitting adverse events and other safety-related data to regulatory authorities and ethics committees."
  },
  {
    "question": "What is trial registration?",
    "answer": "Trial registration is the process of submitting trial details to a publicly accessible database such as ClinicalTrials.gov before recruitment begins."
  },
  {
    "question": "What is ClinicalTrials.gov?",
    "answer": "ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies conducted worldwide."
  },
  {
    "question": "What is double-blind study design?",
    "answer": "In a double-blind study, neither the participants nor the investigators know who is receiving the active treatment or placebo, minimizing bias."
  },
  {
    "question": "What is a principal investigator (PI)?",
    "answer": "The PI is the person responsible for the overall conduct of the clinical trial at a study site."
  },
  {
    "question": "What is trial feasibility?",
    "answer": "Feasibility assesses whether a study can be conducted successfully considering resources, patient population, and site capabilities."
  },
  {
    "question": "What is subject recruitment?",
    "answer": "Subject recruitment is the process of identifying and enrolling eligible participants into a clinical trial."
  },
  {
    "question": "What is an endpoint?",
    "answer": "An endpoint is a primary or secondary outcome used to judge the effectiveness of a treatment."
  },
  {
    "question": "What is pharmacovigilance?",
    "answer": "Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects of medicines."
  },
  {
    "question": "What happens after a trial ends?",
    "answer": "After a trial ends, data are analyzed, results are shared, and if positive, the treatment may move to regulatory approval and clinical use."
  }
]