GVSU-MSU Clinical Research Trials Management Certificate Program

Syllabus for HM 848 Integrated Study Design and Research Informatics for Clinical Trials

Description: This course covers the basics of how clinical trial data are designed, collected, cleaned, monitored and analyzed from the clinical research associate.  The course introduces clinical trial phases, types and objectives.  The course describes the purpose and ambitions of clinical data collection activities of a clinical trial and the Good Clinical Practice (GCP) regulatory principles that guide each phase.  The course consists of lectures three examinations and a presentation. Students are expected to master the learning objectives by viewing the material presented on the web site.  Each Sunday night at midnight the online material will open and remain accessible throughout the remainder of the course.  Students are encouraged to use the discussion board to answer weekly questions about the course content and to post questions or issues.

Examinations: The course will have three examinations.  Exam 1 covers the material from week 1 to week 4.  Exam 2 covers the material from week 6 to week 10.  The cumulative final exam is due on week 13.  The cumulative final exam is a written exam in which students are to design and plan the execution and reporting for a clinical trial.

Term Paper: Students will write a term paper on a famous clinical trial.  The paper will present a clinical trial and the facts and features covered in the course content (objectives, Design, Population, Execution, Results, inclusion in meta analyses and impact on clinical practice).  Students will select a trial and submit a preliminary bibliography for the paper by week 6.

Required Electronic Resources

- Fundamentals of Clinical Trials by Lawrence Freidman, Springer, New York; 2010. An electronic resource. 

- A concise guide to clinical trials by Allan Hackshaw. An electronic resource.

- Strategy and statistics in clinical trials: a non-statisticians guide to thinking, designing and executing a clinical trial; by Joseph Tal. An electronic resource

- A clinical trials manual from the Duke Clinical Research Institute: lessons from a horse named Jim by Margaret Liu. An electronic resource.

Course Objectives

  1. Introduction to clinical trials
    1. Scientific process
      1. background, theory, hypothesis, test/conclusion, repeat)
      2. Koch-Henley Postulates
      3. Hierarchy of evidence
    2. Biological/Clinical objectives
      1. What is nature of the problem
      2. What about the problem is amenable to intervention)
    3. Interventions
      1. Compounds
      2. Devices
      3. Change of practice
    4. Population choices
      1. impact on tests and conclusions
      2. With the wrong controls you can prove anything
    5. Outcomes/Endpoints
      1. what is observable to suggest that an intervention affected the biological or clinical objectives)
    6. Study execution
      1. how to test the hypothesis (intervention changes the endpoint) in the desired population
    7. Safety assessment
      1. pre-clinical to early clinical phases, late clinical phases
    8. Clinical trial phases
    9. Food and Drug Administration
      1. Laws and Regulations about clinical trials
    10. Clinical trials.gov
  2.  Good Clinical Practice
    1. Study protocol
    2. Clinical Trial study population
    3. The randomization process
    4. Blindness
    5. Recruitment of study participants
    6. Adverse Event Assessment and Reporting
    7. Protocol adherence
    8. Study Closeout
    9. Reporting and interpreting results
    10. Multicenter trials
    11. Data Safety and Monitoring boards
  3. Biostatistics for clinical trial study coordinators
    1. The nature of data
    2. Test of statistical inference
    3. The element of time
    4. Sample Size (patients and sites)
    5. Study design
    6. Common statistical tests and the strength of the inference that can be made
    7. Preclinical research
    8. Phase I studies
    9. Phase II studies
    10. Phase III studies
    11. Other study phases
  4. Clinical Data Management
    1. Clinical Research Informatics – 1
      1. Events, observation, data, information, knowledge, wisdom
    2. Safety/Efficacy objectives
    3. Case Report Form Design
    4. Study Database Design
    5. Data Collection
    6. Data Entry
    7. Data Cleaning
      1. Discrepancies
      2. Query Writing
    8. Data freezing/locking
  5. Impact of clinical data management choices on statistical inferences
    1. Data quality
      1. Fitness for use
      2. Missingness and imputation
    2. Principal publications
    3. Secondary publications
      1. Meta analyses, Systematic Reviews
      2. Cochrane’s Reviews
  6. Clinical Research Informatics – 2
    1. Clinical trial management systems
    2. Clinical data management systems
    3. Pharmaceutical operations
  7. Sponsors, Funders and personalities      
  8. Famous Clinical Trials: Objectives, Design, Population, Outcomes, Endpoints, Execution, Results, inclusion in meta analyses and impact on clinical practice.

Course Schedule:

Week 1: Introduction to clinical trials

Week 2 - 4: Good Clinical Practice

Week 5: Exam 1

Week 6 – 7: Clinical Trial statistics

Week 8 - 9: Clinical Data Management

Week 10: Clinical Research Informatics; Clinical Trial Monitoring;

Week 11: Exam 2

Week 12: Term Paper: Famous Clinical Trials and their influence on modern medicine

Week 13: Written Final Exam




Term Paper guidelines

Students will write a term paper.  The paper is due at the end of Week 12.  The paper must present the design, plans for execution, analysis and reporting for a clinical trial.  Students will choose the trial phase and present phase-specific details for the planned trial.  The paper must present details on the full content of the course in the presentation of the planned trial. The paper will be 2,500 or more words.  Students will be graded on the completeness of course content coverage, writing style, appropriateness of the planned details.

Written Final Exam Guidelines

Students will write a 2,500 word (references excluded) paper on a famous clinical.  Students will conduct primary research using PubMed or other sources to find a clinical trial that has several publications and has played a meaningful role in the practice of modern medicine. Students will prepare and submit a preliminary bibliography by Week 6.  The paper may cover several significant publications from trials of the same compound or device. The paper should cover the following suggested outline: Presentation of the clinical problem, biology of the problem, biology of the intervention, preclinical evidence, study population, study phase, study endpoints/outcomes, principal publication(s), presentation in meta-analyses.  Clinical Data Management implications.  Clinical Research Informatics and the chosen trial(s).

Page last modified March 14, 2014