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Official Course
Description: MCCCD Approval: 6-28-2005 |
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CRC210
2005 Fall – 2012 Summer II |
LEC
4.0 Credit(s) 4.0
Period(s) 4.0 Load Occ |
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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: CRC120. |
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Go to Competencies Go to Outline
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MCCCD
Official Course Competencies: |
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CRC210 2005
Fall – 2012 Summer II |
Research Design and Data Management |
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1.
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Define a minimum of 50 common research design and data
management terms and acronyms. (I) |
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2.
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Differentiate between qualitative and quantitative
research methodologies. (I, II) |
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3.
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Define major protocol design options in biomedical
research. (III) |
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4.
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Differentiate basic bio-statistical concepts for protocol
analysis. (IV) |
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5.
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Identify required protocol components. (V) |
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6.
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Describe electronic database design and development. (VI) |
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7.
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List the federally required documents in a regulatory
study binder. (VII) |
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8.
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Compare and
contrast basic case report form designs and presentation methods for
efficiency, ease of completion, and accuracy.(VIII) |
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9.
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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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10.
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Compile sample forms for a research site regulatory,
source data, and IRB correspondence binders. (X) |
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11.
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Describe quality assurance procedures for data procurement
and management. (XI) |
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12.
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Describe the tracking process for investigational agents.
(XII) |
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13.
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Identify the preparation required for a sponsor or
regulatory site audit. (XIII) |
Go to Description Go to top of
Competencies
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MCCCD
Official Course Outline: |
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CRC210 2005
Fall – 2012 Summer II |
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 |