Utilizing ICH Guidelines and FDA Regulations in the Design of Clinical Protocols

The Good clinical practice is a worldwide scientific and ethical quality standard for trials relating to human subjects.  The many actions covered by Good Clinical Practice comprise of oversight of the test activities, data collection and quality assurance, trial designs, control of the test activities, study analysis, human subject protection, and definition of ethically, and scientifically sound trial objectives (Journal of Oncology Practice, 2011). The intentions of all these actions or activities are to support the clinical research, with the vital purposes of civilizing and improving the welfare and health of the patients, and advancing the biomedical science.

Therefore, Good clinical practice is GCP is essentially a structure in which scientific institutions share roles and responsibilities, investigators, industry sponsors, government regulators, and clinical, institutional review boards.  Conversely, one of the biggest challenges in implementing good clinical practices is defining the responsibilities and roles of everyone included, and guarantee a dynamic process whose contributions are complementary. Consequently, all clinical investigations start with the development and expansion of a clinical protocol (Clinical Research Resource HUB, 2015). Apparently, a clinical protocol is a manuscript or document, which describes how a clinical trial conducted, methodology, and the objectives of the clinical protocol, design, statistical considerations, and the arrangement of a clinical trial. Also, a clinical protocol guarantees the integrity of the data collected, and the safety of the trial subjects. According to the ICH Good Clinical plans, a clinical protocol should include the following topics:


  1. Title Page (General Information)
  2. Background Information
  3. Objectives/Purpose
  4. Study Design
  5. Selection and Exclusion of Subjects
  6. Treatment of Subjects
  7. Evaluation of Efficacy
  8. Evaluation of Safety
  9. Adverse Events
  10. Discontinuation of the Study
  11. Statistics
  12. Quality Control and Assurance
  13. Ethics
  14. Data handling and Recordkeeping
  15. Publication Policy
  16. Project Timetable/Flowchart
  17. References
  18. Supplements/Appendices

In conclusion, it is vital to note that clinical investigators experience challenges during the conduct of the clinical trials, which are Clinical investigators face a challenge during the conduct of clinical trials that are diverse from those stumbled upon during the routine practice of medicine. Nonetheless, a lot of these difficulties crop up from the regulatory necessities, rigorous nature of the clinical trials, and the guidelines for Good Clinical Practice. Therefore, when carrying out a clinical trial, it is imperative that the clinical investigator to adequately meet all of the research requirements and expectations.

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