Paper-based clinical research studies statistics

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials. The value of source data verification in a cancer clinical trial. Electronic case-report forms of symptoms and impairments of peripheral neuropathy.

Are EDC systems as efficient as expected? The Clinical Data Management Perspective

Canadian Journal of Neurological Sciences. Informatics tools to improve clinical research study implementation. A multicenter, randomized, open study to evaluate the impact of an electronic data capture system on the care of patients with rheumatoid arthritis. Journal of the American Medical Informatics Association. Data capture by digital pen in clinical trials: a qualitative and quantitative study. Interface for electronic data capture systems for clinical trials by optimal utilization of available hospital resources.

Quantifying data quality for clinical trials using electronic data capture. Electronic data capture EDC using cellular technology: implications for clinical trials and practice, and preliminary experience with the m-Womac Index in hip and knee OA patients. The use of electronic data capture tools in clinical trials: Web-survey of Canadian trials.


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Journal of Medical Internet Research. Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial. Workflows for intelligent monitoring using proxy services. The child and adolescent psychiatry trials network CAPTN : infrastructure development and lessons learned. Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial.

Design and implementation of an institutional case report form library. Fraccaro P, Giacomini M. A web-based tool for patients cohorts and Clinical Trials management. Current state of information technologies for the clinical research enterprise across academic medical centers. Clinical and translational science.

Use of electronic data capture in a clinical trial on infant feeding. European Journal of Clinical Nutrition. An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records. American Journal of Psychiatry. Factors influencing the electronic capture of patient-reported contact lens performance data. Preserving participant anonymity during remote preenrollment consent form checking. Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes in a phase II clinical trial.

Journal of Clinical Oncology. A partnership approach for Electronic Data Capture in small-scale clinical trials. Journal of Biomedical Informatics. Kowitt L, Marlin RL. A comprehensive on-line collection system. Drug Information Journal. Electronic versus paper questionnaires: a further comparison in persons with asthma.

The Clinical Trial Journey

Journal of Asthma. Quality of patient-reported outcome data captured using paper and interactive voice response diaries in an allergic rhinitis study: is electronic data capture really better? Handheld computers for data entry: high tech has its problems too. Trials [Electronic Resource]. Self-assessments of patients via Tablet PC in routine patient care: comparison with standardised paper questionnaires.

4 myths about the benefits of paper-based CRFs | Castor EDC

Annals of the Rheumatic Diseases. Value in Health. Current Alzheimer Research. Comparison of electronic data capture EDC with the standard data capture method for clinical trial data.

Welker JA. Implementation of electronic data capture systems: barriers and solutions. Using technology to promote gastrointestinal outcomes research: a case for electronic health records. American Journal of Gastroenterology.

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Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial

Facilitating secondary use of medical data by using openEHR archetypes. The automatic clinical trial: leveraging the electronic medical record in multisite cancer clinical trials. Current Oncology Reports. Development of an open metadata schema for prospective clinical research openPCR in China. Methods of Information in Medicine.

A statistical approach to central monitoring of data quality in clinical trials. Application of methods for central statistical monitoring in clinical trials. Central statistical monitoring: detecting fraud in clinical trials. The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial. Remote source document verification in two national clinical trials networks: a pilot study.

Economic analysis of centralized vs. Paradigm shifts in clinical trials enabled by information technology. Stat Med.


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Stafford PB, Garrett A. PloS one. Grignolo A. Reflection paper on risk based quality management in clinical trials 4 August Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials. You are commenting using your WordPress. You are commenting using your Google account. You are commenting using your Twitter account. You are commenting using your Facebook account.

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  7. March 11, Data Resources in the Health Sciences An inventory of resources to support research data needs in the health sciences field. This guide is constantly being updated; please send feedback via the Comments links. For additional administrative and survey sources such as healthdata. For registry sources, see Data Repository Registries. Electronic Health Record The purest type of electronic clinical data which is obtained at the point of care at a medical facility, hospital, clinic or practice.

    Administrative Data Often associated with electronic health records, these are primarily hospital discharge data reported to a government agency like AHRQ. It provides access to health statistics and information on hospital inpatient and emergency department utilization. The project includes a number of datasets and sample studies listed under the information icon.

    Datasets are available for purchase. Claims Data Claims data describe the billable interactions insurance claims between insured patients and the healthcare delivery system.

    Associated Data

    There are some demographic and claim-related variables provided in every PUF. Medicare Provider Utilization and Payment Data Data that summarize utilization and payments for procedures, services, and prescription drugs provided to Medicare beneficiaries by specific inpatient and outpatient hospitals, physicians, and other suppliers. Medicaid Data Sources The Medicaid Analytic eXtract data contains state-submitted data on Medicaid eligibility, service utilization and payments.

    Medicaid Statistical Information System MSIS is the basic source of state-submitted eligibility and claims data on the Medicaid population, their characteristics, utilization, and payments and is available by clicking on the link on the left-side column. The NCDR encompasses six hospital-based registries and one outpatient registry. There are currently more than 2, hospitals and nearly 1, outpatient providers participating in NCDR registries.

    National Program of Cancer Registries CDC provides support for states and territories to maintain registries that provide high-quality data. With double data entry multiply by 2. If you lose paper — the data is lost.

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