Clinical Data Management

Clinical Data Management

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  Clinical data managementMadeby:-ShrayJali
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  Clinical dataMost valuableasset to a pharmaceutical company
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  Serves as abasis for submission, approval, labelling and marketing of a compound
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  Sources:
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  Subject-investigator interaction atsites (e.g. Remote Data Capture (RDC) technology)
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  Laboratories
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  Directly from subjectsand partners (e.g. Contract Research Organizations - CROs)
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  Clinical trialsConducted toallow safety and efficacy data to be collected for new drugs or devices
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  Health Authority/Ethics Committeeapproval is necessary
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  Often a clinicaltrial is managed by an outsourced partner such as a CRO
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  Includes measurements likevital signs, amount of study drug in the blood, and whether the patient's health gets better or not & then the data is sent to the trial sponsor who analyses the pooled data using statistical testsClinical trials
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  Clinical data managementUsedin clinical research to manage the data of a clinical trial
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  Clinical trial datagathered at the investigator site in the case report form are stored in the CDMS
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  To reduce thepossibility of errors due to human entry, the systems employ different means to verify the entry such as double data entryClinical data managementCoding of data: adverse event terms and medication names
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  Standard dictionaries ofthese terms can be loaded into the CDMS
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  Some systems allowfor the storage of synonyms to allow the system to match common abbreviations and map them to the correct termExample: ASA could be mapped to Aspirin
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  Clinical data managementDatagathered during clinical trials is stored within a CDMS
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  Ensures that humanerror will be kept to a minimum
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  Software systems ofthis type also file data and screen data for any illogical patterns
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  Helps researchers toscrutinize their material. Clinical software has largely replaced manual inputting of data. Most programs of this type include spreadsheetClinical data management
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  double dataentryMethod of quality control, very useful in catching and correcting typographical errors
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  Also known asTwo pass verificationSpecial features of our Double Keyed Data Entry Service:High accuracy
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  High data security
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  Affordable rates
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  Efficient validation procedures
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  Advanced technology
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  Flexibility
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  Duplicate check identificationDictionarymanagementStores the structure of the structure of the clinical data tables so that they can be accessed correctly
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  Also known asmetadata (Data table restricted to information about data elements) repository
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  e.g. MedDRAfor adverseevents and WHO Drug for medications Dictionary management
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  Clinical database search
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  Dictionary management
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  Need for cdmsTofind ways to cut both costs and time from the clinical development process
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  Get an accurate,real-time view of clinical trial forecasts and budgets
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  Effectively use criticalinformation and collaboratively assess performance.
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  Aggregation of dataand its Dissemination via an open framework
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  To limit error,improve control, enhance visibility, and boost accountability