BMI+211+01.19.10

BMI+211+01.19.10 - Effective Design in Clinical Informatics...

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Effective Design in Clinical Informatics BMI 211/CS 271 Amar Das Assistant Professor Medicine (Biomedical Informatics)
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Announcements Example project report available Homework #1 is due this Friday Site visits Packard Children’s Hospital Friday, February 19th, 3 to 5 PAMF TBA Guest lecture on February 2
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Planned Assignments Assignment Released Due HW #1 1/15 1/22 Mid quarter presentation 1/28 HW #2 2/5 2/12 HW #3 2/19 2/26 End quarter presentation 3/2, 3/4 HW #4 3/5 3/12 Written report 3/19
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Course Lectures Week 2: Requirements analysis Week 3: Functional specification and design Week 4-6: System architecture Week 7-8: Human-system interaction Week 10: Industry perspectives
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Development of a Clinical Trials Management System
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Clinical Trials Management Clinical trials are used to determine whether new drugs or treatments are both safe and effective Complex clinical trials involve collaboration among many groups using different software applications
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Clinical Trial Process Design  Conducting Analysis Publishing Initial Steps Formulate the research question Establish the need for a clinical trial study Define the study objectives
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Immune Tolerance Network Investigator-initiated clinical trials of novel tolerance-promoting therapies in Autoimmune diseases Transplantation Allergy and Asthma
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ITN Clinical Trials Management ITN is a nation-wide research organization designed to bring researchers together to conduct trials on immune- mediated disorders This goal requires Collaborative efforts of laboratory scientists, clinical investigators, and technical experts Centralization of research services when possible Central data collection for mechanistic model building
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Trials Management Process Design Conduct Analyze Core CRF Tracking
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1 BACKGROUND AND RATIONALE 2 OBJECTIVES 3 STUDY DESIGN 4 SELECTION AND TERMINATION OF PARTICIPANTS 4.1 Inclusion Criteria 4.2 Exclusion Criteria 5 STUDY MEDICATIONS 6 STUDY PROCEDURES 6.1 Intensive Diabetes Management 6.2 Enrollment and Randomization 6.3 Study Treatment Visits 6.4 Visit Windows 6.5 General Assessments 6.6 Laboratory Assessments 6.7 ITN Core Laboratory Assessments 6.8 Study Treatment Assignment Procedures 7 MECHANISTIC ASSAY STUDIES 8 SAFETY MONITORING 9 STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN 10 IDENTIFICATION AND ACCESS TO SOURCE DATA 11 QUALITY CONTROL AND QUALITY ASSURANCE The Clinical Trial Protocol specifies the plan
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Schedule of Activities lists the activities and when they should be performed
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Specimen Workflow Table contains information on the processing of biological specimens
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Various software applications are used to manage patient data and sample collection CRO Protocol Group Assay  Group Cimarron Operations Group Tubes  Manufacturer Data  Center Schedule  of Events Specimen Table Tube Table CRF ImmunoTrak Kit Report Clinical  Trial  Data Core Labs Assay Results Queries Reports Queries Reports
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Trial information generated by different groups
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BMI+211+01.19.10 - Effective Design in Clinical Informatics...

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