Download - Uses of Patient Registries for Clinical Studies to Acquire Unwavering Data: Pepgra Healthcare
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USES OF PATIENTREGISTRIES FOR CLINICALSTUDIES TO ACQUIREUNWAVERING DATA
An Academic presentation byDr. Nancy Agnes, Head, Technical Operations, PepgraGroup: www.pepgra.comEmail: [email protected]
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In-Brief
Introduction
Patient Disease Registries
Patient Population
Time Elements
Core Data Elements
Today's Discussion
OUTLINE
Terminologies
Quality Management
Safety Analysis
Governance
Conclusion
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In Brief
The patient registry is a specific study or a detailed survey of researchquestion or hypothesis generally. Clinical research statistical service is acollection of data from a particular population, the following details explain
about the patient registry and their methodological and operationalaspects. Pepgra strengthens your knowledge about the patient registries
in the medical field for the development of future clinical aspects andstudies in the clinical biostatistics and programming.
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Introduction Patient registry is a coordinated system takes placeusing observational methods to acquire unwaveringdata on patient population based on the specificdisease, exposure and conditions. It follows the time.
The patient disease registries are created by publicorganizations, including educational institutions, medicalresearch association and clinical study design.
The overall objectives may vary such as to explain thenatural history of a disorder, to analyze the impacts ofdisease on patients health and routine life, to findpatients with an affinity for new treatments.
The registry also used for the evaluation of the safety ofmedicines and in the Clinical Biostatistics service.
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PatientDiseaseRegistries
Patient population
Time elements
Core data elements
Terminologies
Quality management
Safety analysis
Governance
Our biostatistics consulting services consider theseessential factors to create and maintain a patient registrythey are.
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PatientPopulation The patient population should be with more
excellent care, and various factors influencethe selection of the community.
It is vital to ensure comprehensiveenrolment of patients and bias selection withthe Clinical Biostatistics & StatisticalProgramming Service during thetherapeutics of clinical research.
Contd..
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To create a logical definition on selected population.
Convert logical description into the operational definition.
Make a process in which enrolled patients should represent the working definition.
Complete follow up on each patient to gather detailed data.
The four essential steps to be carried out in our biostatistics programming services are.
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TimeElements
The accurate follow up on date and time is essential inthe Biomedical research as it is the primary factor for thecomputation of period critical to the valid analysis ofdata includes time difference between registry entry andexposure to medicines, different treatment time and theonset of adverse events on a particular interest, recoveryfrom an adverse effect, effectiveness time, clinicalimprovement time etc.
Clinical Biostatistics Consulting Services have the timeelements that vary based on disease and variousfactors, but there are some major time elements shouldbe present in any registry are:
Contd..
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Patient Dates include the date of birth, date of death, date of pregnancy, registryentry date, registry exit date, informed consent date
Disease Dates include the date of the first symptom, date of early diagnosis, dateof a definitive diagnosis, date of cure or improvement, date of relapse, date ofcomorbid events occurrence, date of the resolution of comorbid events
Investigation Dates include the date of test 1, test2, test 3
Treatment Dates include start date, stop date
Contd..
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AESI Dates include the date of any AESI occurrence, date of any AESIresolution
Other Event Dates
Observation Dates include the date of follow up
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Core DataElements
Core data elements are the harmonized data formon all patients the information of the same diseasein all registries should be identical to maintainstandard data quality system, data exchange, formaldata analysis for many patients and to compare theresults of different registries in the Statisticalprogramming CRO services.
Contd..
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Patient dataDisease
Co-morbidities
Disease-related treatments
The most critical data elements for patient registries are
Contd..
Other therapies
Adverse effectsPregnancy
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Terminologies
The data harmonization, it is essential tochange native languages to internationalterminologies, the guidelines for languages arefollowed based on the suggestion from EMA asper the clinical trial statistics service.
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QualityManagement
Quality planningQuality assurance
Clinical research biostatistics services qualitymanagement involves four main activities they are:
Quality control
Quality improvement
Consistency
Completeness
There are four main requirements of data quality
Accuracy
Timeliness
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SafetyAnalysis
Reporting of safety information
Monitoring of adverse effects of special interests
Aggregate analysis of adverse effects
Statistical programming CRO’s Safety analysisinvolves
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Governance
Most registries have a governance modelrelying on principles and constraints based ontheir mandate operating procedure, legalenvironment or funding sources.
Registry coordinators, MAA/MAH andregulators, strengthen the use of registry data.
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ConclusionPatient registry is an essential aspect of medicinalregulation as valuable data sources on diseaseand treatment.
In the pilot phase and specific disease-relatedworkshop, it is necessary to consider somefactors such as a recommendation from theregulators on the type of data, an acceptablelevel of quality and requirement regards safetyreporting guided by Pepgra.