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  1. data/clinical_faq.json +102 -0
  2. data/faq_data.json +4 -0
  3. data/gitkeep +0 -0
  4. data/urls.txt +69 -0
data/clinical_faq.json ADDED
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+ [
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+ {
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+ "question": "What is a clinical trial?",
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+ "answer": "A clinical trial is a research study in which volunteers receive interventions to evaluate their effects on health outcomes."
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+ },
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+ {
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+ "question": "What are the phases of clinical trials?",
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+ "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."
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+ },
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+ {
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+ "question": "What is informed consent?",
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+ "answer": "Informed consent is a process in which potential participants are educated about the purpose, procedures, risks, and benefits before agreeing to participate."
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+ },
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+ {
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+ "question": "What is a placebo?",
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+ "answer": "A placebo is an inactive substance or treatment designed to resemble the intervention being tested, used to measure true treatment effects."
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+ },
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+ {
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+ "question": "What is randomization?",
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+ "answer": "Randomization is the process of assigning participants to different trial arms by chance, reducing bias."
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+ },
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+ {
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+ "question": "What is a CRO?",
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+ "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."
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+ },
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+ {
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+ "question": "What is an SAE?",
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+ "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."
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+ },
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+ {
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+ "question": "What is a DSMB?",
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+ "answer": "A Data Safety Monitoring Board (DSMB) is an independent group of experts that monitors safety and efficacy data during a clinical trial."
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+ },
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+ {
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+ "question": "Who regulates clinical trials in the US?",
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+ "answer": "The Food and Drug Administration (FDA) regulates clinical trials of drugs and devices in the US."
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+ },
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+ {
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+ "question": "Who regulates clinical trials in Europe?",
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+ "answer": "The European Medicines Agency (EMA) oversees the scientific evaluation, supervision, and safety monitoring of medicines in the EU."
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+ },
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+ {
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+ "question": "Who regulates clinical trials in India?",
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+ "answer": "The Central Drugs Standard Control Organization (CDSCO) regulates clinical trials in India."
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+ },
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+ {
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+ "question": "What is Good Clinical Practice (GCP)?",
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+ "answer": "Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials."
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+ },
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+ {
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+ "question": "What is trial monitoring?",
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+ "answer": "Monitoring ensures that the rights and well-being of participants are protected, data are accurate, and the trial complies with protocols and regulations."
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+ },
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+ {
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+ "question": "What is protocol deviation?",
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+ "answer": "A protocol deviation is an unplanned departure from the approved trial procedures, potentially affecting participant safety or data integrity."
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+ },
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+ {
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+ "question": "What is efficacy?",
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+ "answer": "Efficacy refers to how well a treatment works under controlled conditions in a clinical trial."
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+ },
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+ {
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+ "question": "What is safety reporting?",
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+ "answer": "Safety reporting involves documenting and submitting adverse events and other safety-related data to regulatory authorities and ethics committees."
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+ },
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+ {
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+ "question": "What is trial registration?",
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+ "answer": "Trial registration is the process of submitting trial details to a publicly accessible database such as ClinicalTrials.gov before recruitment begins."
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+ },
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+ {
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+ "question": "What is ClinicalTrials.gov?",
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+ "answer": "ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies conducted worldwide."
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+ },
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+ {
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+ "question": "What is double-blind study design?",
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+ "answer": "In a double-blind study, neither the participants nor the investigators know who is receiving the active treatment or placebo, minimizing bias."
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+ },
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+ {
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+ "question": "What is a principal investigator (PI)?",
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+ "answer": "The PI is the person responsible for the overall conduct of the clinical trial at a study site."
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+ },
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+ {
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+ "question": "What is trial feasibility?",
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+ "answer": "Feasibility assesses whether a study can be conducted successfully considering resources, patient population, and site capabilities."
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+ },
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+ {
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+ "question": "What is subject recruitment?",
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+ "answer": "Subject recruitment is the process of identifying and enrolling eligible participants into a clinical trial."
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+ },
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+ {
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+ "question": "What is an endpoint?",
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+ "answer": "An endpoint is a primary or secondary outcome used to judge the effectiveness of a treatment."
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+ },
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+ {
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+ "question": "What is pharmacovigilance?",
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+ "answer": "Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects of medicines."
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+ },
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+ {
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+ "question": "What happens after a trial ends?",
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+ "answer": "After a trial ends, data are analyzed, results are shared, and if positive, the treatment may move to regulatory approval and clinical use."
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+ }
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+ ]
data/faq_data.json ADDED
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+ [
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+ {"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."},
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+ {"question": "What is informed consent?", "answer": "Informed consent is a process where participants are educated about the trial and voluntarily agree to participate."}
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+ ]
data/gitkeep ADDED
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data/urls.txt ADDED
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+
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+ https://clinicaltrials.gov/
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+ https://www.cdisc.org/
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+ https://www.scdm.org/
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+ https://www.fda.gov/
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+ https://open.fda.gov/
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+ https://www.ema.europa.eu/
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+ https://www.ich.org/
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+ https://www.who.int/data/gho
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+ https://opentrials.net/
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+ https://www.rd-alliance.org/
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+ https://pubmed.ncbi.nlm.nih.gov/
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+ https://www.ncbi.nlm.nih.gov/books/
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+ https://www.who.int/news-room/questions-and-answers/item/clinical-trials-data-sharing
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+ https://www.fda.gov/drugs/drug-information-drug-class/clinical-research
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+ https://www.nih.gov/
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+ https://www.nih.gov/research-training/clinical-research-resources
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+ https://www.nih.gov/health-information/nih-clinical-research-trials-you
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+ https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication
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+ https://report.nih.gov/
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+ https://www.who.int/observatories/global-observatory-on-health-research-and-development/resources/databases/databases-on-processes-for-r-d/clinical-trials
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+ https://www.cochranelibrary.com
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+ https://scholar.google.com/
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+ https://register.clinicaltrials.gov
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+ https://clinicalstudies.info.nih.gov/
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+ https://www.ninds.nih.gov/current-research/research-funded-ninds/clinical-research/archived-clinical-research-datasets
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+ https://www.centerwatch.com/
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+ https://www.antidote.me/
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+ https://www.trialscope.com/
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+ https://www.researchmatch.org/
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+ https://www.ncbi.nlm.nih.gov/pmc/
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+ https://www.nejm.org/
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+ https://www.thelancet.com/
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+ https://jamanetwork.com/
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+ https://www.bmj.com/
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+ https://www.nature.com/
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+ https://www.consort-statement.org/
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+ https://www.spirit-statement.org/
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+ https://www.alltrials.net/
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+ https://www.transceleratebiopharmainc.com/
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+ https://www.clinicaltrialsarena.com/
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+ https://www.trialsite.news/
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+ https://www.wcgclinical.com/
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+ https://www.socranet.org/
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+ https://www.acrpnet.org/
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+ https://www.r-project.org/
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+ https://www.clinicalresearchinformatics.org/
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+ https://www.eclinicalforum.org/
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+ https://www.icrmanagement.com/
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+ https://www.parexel.com/
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+ https://www.iqvia.com/
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+ https://www.labcorp.com/
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+ https://www.syneoshealth.com/
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+ https://www.medicinenet.com/
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+ https://www.drugs.com/
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+ https://www.druglib.com/
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+ https://www.clinicaloncologyonline.net/
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+ https://www.healthit.gov/
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+ https://www.healthaffairs.org/
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+ https://www.biomedcentral.com/
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+ https://www.frontiersin.org/
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+ https://www.researchgate.net/
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+ https://www.orcid.org/
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+ https://www.crossref.org/
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+ https://www.clinicalresearchtraining.org/
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+ https://www.ema.europa.eu/en/human-regulatory-overview
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+ https://www.nihclinicalcenter.org/
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+ https://www.healthresearchpolicy.org/
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+ https://www.nature.com/collections/clinical-research