You will be shown an abstract from a biomedical research paper. Given this abstract, your task is to extract all unique entities of the following types: ["HealthCareActivity", "InjuryOrPoisoning", "BodySubstance", "IntellectualProduct", "AnatomicalStructure", "SpatialConcept", "Chemical", "Bacterium", "MedicalDevice", "Organization", "BiomedicalOccupationOrDiscipline", "Finding", "BiologicFunction", "Virus", "ResearchActivity", "ClinicalAttribute", "PopulationGroup", "Eukaryote", "BodySystem", "Food", "ProfessionalOrOccupationalGroup"].

Please return the output as a JSON object of the format: {"Virus": ["HIV", ...], "Bacterium": ["MRSA", ...], "AnatomicalStructure": ["Lung", ...], "BodySystem": ["CNS", ...], "BodySubstance": ["Serum", ...], "Finding": ["Headache", ...], "InjuryOrPoisoning": ["Fracture", ...], "BiologicFunction": ["Death", ...], "HealthCareActivity": ["Biopsy", ...], "ResearchActivity": ["Clinical trial", ...], "MedicalDevice": ["Lenses", ...], "SpatialConcept": ["Camps", ...], "BiomedicalOccupationOrDiscipline": ["Forensic medicine", ...], "Organization": ["WHO", ...], "ProfessionalOrOccupationalGroup": ["Provider", ...], "PopulationGroup": ["Swimmers", ...], "Chemical": ["Gold", ...], "Food": ["Rice", ...], "IntellectualProduct": ["RPAM", ...], "ClinicalAttribute": ["Biomarker", ...], "Eukaryote": ["Dogs", ...]}. The keys should be entity types and values should be lists of extracted entities belonging to the corresponding type. If you cannot find entities belonging to a specific type, the value should be [].

Only output the JSON object and do not include any additional text.

Abstract:

Collecting and Reporting Safety Data and Monitoring Trial Conduct In Pragmatic Trials Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorisation. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials. This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that, all serious adverse events (SAEs) and all drug -related events must be reported in an interventional trial. In line with current guidance, we propose a risk based approach to the collection of non - drug related non-serious AEs, and even serious events not related to treatment based on the risk profile of the medicine /class in the patient population of interest. Different options available to support the collection and reporting of safety data whilst minimizing study -related follow-up visits are discussed. A risk -based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials, and the careful consideration that must be given to the mitigation and management of these risks in order to maintain routine care.
{"AnatomicalStructure": [], "Bacterium": [], "BiologicFunction": [], "BiomedicalOccupationOrDiscipline": [], "BodySubstance": [], "BodySystem": [], "Chemical": ["medicine", "drug"], "ClinicalAttribute": [], "Eukaryote": [], "Finding": ["SAEs", "non-serious AEs", "serious adverse events", "non"], "Food": [], "HealthCareActivity": ["treatment", "management of these risks", "follow-up visits", "interventional"], "InjuryOrPoisoning": [], "IntellectualProduct": ["ICH"], "MedicalDevice": [], "Organization": [], "PopulationGroup": ["population"], "ProfessionalOrOccupationalGroup": [], "ResearchActivity": ["Pragmatic trials", "study", "pragmatic trials", "reporting of safety data", "reporting safety data", "pragmatic trial", "monitoring trial conduct", "collection", "Monitoring Trial Conduct", "clinical trials", "Reporting Safety Data", "collecting", "trial", "Collecting", "Pragmatic Trials"], "SpatialConcept": ["approach"], "Virus": []}