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To develop expertise in research design and statistical analyses appropriate to clinical research. The content of the program can be defined in a number of ways: the purposes of research, research design concepts, data collection methods, and statistical or analytical methods. The program provides concepts and methods that relate to the purposes of clinical research, clinical epidemiology, clinical trials, program evaluation, and technology assessment.
Research design concepts include the traditional approaches to the scientific method; the concepts of validity, reliability, causal relationships, role of randomization, standards for comparison, and sampling, as well as other recently developed methods of approaching decisions about research outcomes such as decision analysis and cost-utility analysis. The data collection methods deal with instrumentation, questionnaire construction, non reactive measures, survey techniques, qualitative data, measurement and standardization problems, concepts and criteria of normalcy, and disease and diagnostic criteria.
Statistical techniques for estimation and hypothesis testing, including comparison of proportions, chi-square test, comparison of means, analysis of variance and covariance, multiple regression analysis, logistic regression, and survival analysis are presented. In addition to a comprehensive curriculum in research design and statistical analysis, other content relevant to clinical researchers is included: ethical and legal issues in clinical research, technical writing skills and proposal/report writing, management of research, and behavioral factors in clinical research. Students learn computer skills and concepts, including data file management, data organization, and use of statistical packages. Visiting faculty with experience in specialized research subjects meet with the students to discuss current problems in clinical research.
Criteria for Course Completion
Each student must complete
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Comprehensive cumulative examination with a minimum score of 70% |
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Perform a mock monitoring visit identifying a minimum of 80% deficiencies. |
The candidate will receive a certificate of completion as a Clinical Research Professional.
In addition, each student must pass
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GCP Regulatory/ICH Guideline examination with a minimum score of 70 % |
The candidate will receive a certificate of recognition for passing this examination.
Curriculum
| 1 |
The Food and Drug Administration Past and Present |
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The Establishment of the Food and Drug Administration |
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The History of the Legislation and Regulations, which Govern the Clinical Research Process |
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The History of the Legislation and Regulations, which Protect the Rights, Safety, and Well-Being of Human Subjects |
| 2 |
Overview of Medicinal Product Research and Development |
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Drug Discovery and Pre-Clinical Research |
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The Clinical Research and New Drug Application Approval Process |
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The Biologics Research, Development, and Licensing Process |
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Medical Device Research, Development, and Marketing |
| 3 |
Good Clinical Practice (GCP) |
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Investigational New Drug Application 21 CFR 312: Sponsor’s Obligations |
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Investigational New Drug Application 21 CFR 312: Investigator’s Obligations |
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Institutional Review Boards 21 CFR 56 |
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Protection of Human Subjects 21 CFR 50 |
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Financial Disclosure 21 CFR 54 |
| 4 |
International Conference of Harmonization |
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The History of the International Conference of Harmonization |
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The ICH Good Clinical Practice Consolidated Guideline (E6) |
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The ICH Clinical Safety Data Guideline (E2) |
| 5 |
Clinical Trial Development |
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Protocol Design and Development |
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Case Report Form Design and Development |
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Principals of Data Management and the Query Resolution Process |
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The Study Types Providing Expanded Access to Investigational Products |
| 6 |
Clinical Trial Management |
Investigator Site Perspective:
Coordinating a Clinical Trial at the Site |
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Essentials of Source Documentation |
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Maintaining and Managing Essential Documents |
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Recording and Reporting Non-Serious and Serious Adverse Events |
Sponsor’s Perspective:
Managing a Clinical Trial |
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Selecting Investigators and Monitors |
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Maintaining and Managing Essentials Documents (e.g. FDA Form 1572) |
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Case Report Form Data Transmission and Generation of the Clinical Study Report |
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Reviewing and Reporting of Serious Unexpected Adverse Drug Experiences |
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Implementing a Monitoring Plan and Performing Quality |
| 7 |
Monitoring Obligations and Methods |
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Monitoring Role and Responsibilities According to the FDA Guideline |
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Monitoring Role and Responsibilities According to ICH Good Clinical Practice Consolidated Guideline (E6) |
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Monitoring Responsibilities: Type of Monitoring Visits, Monitoring Activities Pre-Visit, On-Site, and Post Visit |
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Monitoring Method: Implementing a Systematic Monitoring Approach to Effectively Monitor a Multi-Center Trial |
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Problem Solving and Trouble Shooting GCP / ICH Issues |
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Writing Strategic Monitoring Reports and Follow-Up Visit Letters |
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