Clinical Research Training Program

Thesis Guidelines

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Final Objective:The CRTP Scholar should be able to utilize theoretical and practical aspects of learning to design, execute and present the results of hypothesis-driven clinical research consistent with the missions of CRTP: “to identify, educate, and mentor clinician scientists for productive careers in clinical research.”

Enabling Objectives: The CRTP Scholar should complete a scholarly thesis, which will lead to further research activity in accordance with the following principles.

1. Hypothesis 

  • What is/are the specific questions to be answered?
  • What population will be studied?
  • What is the setting, e.g., academic hospital-based, outpatient-based, community-based?
  • What final population will the findings be applied to?

2. Study Design 

  • What will be the nature of the study, e.g., randomized controlled clinical study, case control study, retrospective analysis of data?
  • What will constitute the control group/s?
  • Are inclusion and exclusion criteria clearly defined?
  • How will the potential for sample selection bias be minimized?
  • Are primary and secondary end-points justified and clearly defined?
  • Will the study have sufficient sample size and statistical power?

3. Data collection 

  • Has the reliability and reproducibility of observations been assured?
  • Are data collection methods appropriate with adequate sensitivity and specificity to analyze study end-points?

4. Data analysis 

  • Are data internally consistent, i.e., do the numbers add up, are subgroups reconciled, are data tables correct?
  • Are charts and tables utilized appropriately? Are data amenable to statistical analysis? Have relevant statistical methods been correctly applied? Have statistical methods used clearly identified for individual data sets?
  • How reliable is the significance of data? Have additional statistical methods been applied or comparisons made to verify whether differences hold up?
  • Does data analysis include consideration of the sensitivity and specificity of the findings?
  • Does data analysis consider the possibility of confounding variables, including incompatibilities between control and experimental groups?

5. Data interpretation and conclusions 

  • Are conclusions justified by the data analysis? Has the hypothesis been adequately tested?
  • Are findings discussed appropriately and placed in proper context with the existing literature?
  • What are the limitations and weaknesses of the study? What further questions will be appropriate to address? How will the studies guide or lead to future clinical research of the scholar?

6. Objective evaluation of research 

  • Evaluation of the specific areas indicated above will be appropriate for determining the quality of research and whether the goals of thesis work have been met.
  • The completed thesis should provide insights into the overall breadth and depth of the scholar’s knowledge in clinical research.
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