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Official Course
Description: MCCCD Approval: 09/27/05 |
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HSE210 20034-20055 |
LEC |
4 Credit(s) |
4 Period(s) |
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Research Design and Data Management |
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Major research design methodologies and data management. Interpretation of research design, organization of study charts and data, participant eligibility, and maintenance of screening/visit logs. Submission of adverse event forms. Overview of database structures, electronic data collection methods, and effective presentation of data in required reports and publications. Tracking of investigational agents and preparation for audits and site visits by sponsors and/or regulators. Prerequisites: CRC/HSE120 or equivalent. |
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Cross-References: CRC210 |
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Go to Competencies Go to Outline
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MCCCD Official Course Competencies: |
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HSE210 20034-20055 |
Research Design and
Data Management |
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1. |
Define a minimum of 50 common research design and data management terms and acronyms. (I) |
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2. |
Differentiate between qualitative and quantitative research methodologies. (I, II) |
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3. |
Define major protocol design options in biomedical research. (III) |
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Differentiate basic bio-statistical concepts for protocol analysis. (IV) |
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Identify required protocol components. (V) |
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Describe electronic database design and development. (VI) |
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Prepare a subject data binder for a clinical research project. (VII) |
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Prepare basic case report forms for a sample protocol including screening and eligibility logs. (VIII) |
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List the required forms for protocol submission to an Institutional Review Board (IRB), Contract Research Organization (CRO) and Food and Drug Administration (FDA). (IX) |
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Compile participant and site regulatory, source data, and IRB correspondence binders. (X) |
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Describe quality assurance procedures for data procurement and management. (XI) |
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12. |
Describe the tracking process for investigational agents. (XII) |
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13. |
Identify the preparation required for a sponsor or regulatory site audit. (XIII) |
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Go to Description Go to top of Competencies
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MCCCD Official Course Outline: |
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HSE210 20034-20055 |
Research Design and
Data Management |
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I. Research Design and Data Management A. Terminology/Definitions 1. Terms 2. Acronyms B. Research Design Formats C. Data Management Processes D. Development of Electronic Data Bases E. Ethical Considerations of Data Management II. Overview of Qualitative and Quantitative Research A. Types of Quantitative Research 1. Descriptive 2. Correlational 3. Quasi-experimental 4. Experimental B. Types of Qualitative Research 1. Phenomenological 2. Grounded theory 3. Ethnographic 4. Historical 5. Philosophical inquiry 6. Critical social theory III. Protocol Design Options A. Prospective vs. Retrospective B. Blinded vs. Non-blinded C. Double/Triple Blinded D. Controlled vs. Uncontrolled E. Randomized vs. Nonrandomized F. Parallel vs. Crossover IV. Basic Bio-statistical Concepts A. Population and Sample B. Measurement Methods C. Variable Determinates D. Hypothesis Development E. Bias Concepts V. Protocol Components A. Study Description B. Subject Selection C. Procedures D. Investigational Brochure VI. Electronic Database Design and Development A. Data Input Methods B. Confidentiality Issues C. Transmittal Techniques D. Data Verification E. Database Integration VII. Compiling Subject Research Data A. Source Data vs. Shadow Charts B. Data Storage Requirements C. Integration of Regulatory and Subject Data VIII. Development of Case Report Forms A. Screening Log Requirements B. Eligibility Log Requirements C. Procedure/Visit Log Documentation D. Elements and Formats for Case Report Forms IX. Protocol Submission Forms A. IRB Ongoing Monitoring Forms B. FDA General Submission Forms 1. Phase II 2. Phase III C. CRO Required Data Elements X. Research Data Organization A. Site Regulatory Binder B. Subject Source Data Binder C. IRB Correspondence Binder XI. Quality Assurance for Data Management A. Obtaining Medical records B. Data Abstraction C. Data modification Methods D. Closed Ended Questions for Unambiguous Data Capture E. Feedback Methods to Investigators 1. Protocol deviations 2. Adverse events 3. Other XII. Investigational Agent Tracking Requirements A. Investigational Drug Accountability Record B. Regulatory Oversight for Investigational Drugs C. Methods for Inter-site Drug Tracking D. Drug Storage issues XIII. Site Audits: Sponsors and Regulators A. Internal Site Audit Components B. External Site Audit Components 1. Federal regulatory 2. State regulatory 3. Sponsor/monitors 4. IRB/institutional |