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PGDCR in Clinical Research
Master of Science Program in Clinical Research Design and Statistical Analysis
Coordinating a Clinical Trial
Drug/Biologic Approval Process, Good Clinical Practices and an Overview of Monitoring/FDA BIMO Inspections
Advanced Quality Monitoring
Writing Professional and Effective Monitoring Report, Post Visit Letters, and Memo-to-Files
 
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

Comprehensive cumulative examination with a minimum score of 70%
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

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
The Establishment of the Food and Drug Administration
The History of the Legislation and Regulations, which Govern the Clinical Research Process
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
Drug Discovery and Pre-Clinical Research
The Clinical Research and New Drug Application Approval Process
The Biologics Research, Development, and Licensing Process
Medical Device Research, Development, and Marketing

3 Good Clinical Practice (GCP)
Investigational New Drug Application 21 CFR 312: Sponsor’s Obligations
Investigational New Drug Application 21 CFR 312: Investigator’s Obligations
Institutional Review Boards 21 CFR 56
Protection of Human Subjects 21 CFR 50
Financial Disclosure 21 CFR 54

4 International Conference of Harmonization
The History of the International Conference of Harmonization
The ICH Good Clinical Practice Consolidated Guideline (E6)
The ICH Clinical Safety Data Guideline (E2)

5 Clinical Trial Development
Protocol Design and Development
Case Report Form Design and Development
Principals of Data Management and the Query Resolution Process
The Study Types Providing Expanded Access to Investigational Products

6 Clinical Trial Management
Investigator Site Perspective:
Coordinating a Clinical Trial at the Site
Essentials of Source Documentation
Maintaining and Managing Essential Documents
Recording and Reporting Non-Serious and Serious Adverse Events
Sponsor’s Perspective:
Managing a Clinical Trial
Selecting Investigators and Monitors
Maintaining and Managing Essentials Documents (e.g. FDA Form 1572)
Case Report Form Data Transmission and Generation of the Clinical Study Report
Reviewing and Reporting of Serious Unexpected Adverse Drug Experiences
Implementing a Monitoring Plan and Performing Quality

7 Monitoring Obligations and Methods
Monitoring Role and Responsibilities According to the FDA Guideline
Monitoring Role and Responsibilities According to ICH Good Clinical Practice Consolidated Guideline (E6)
Monitoring Responsibilities: Type of Monitoring Visits, Monitoring Activities Pre-Visit, On-Site, and Post Visit
Monitoring Method: Implementing a Systematic Monitoring Approach to Effectively Monitor a Multi-Center Trial
Problem Solving and Trouble Shooting GCP / ICH Issues
Writing Strategic Monitoring Reports and Follow-Up Visit Letters

 
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