The research protocol describes in detail how the clinical trial will be conducted.  Essential components of the protocol include the purpose of the study, the types of data being collected, data management and record keeping, outcome measures, data analysis and conclusions. Protocol development and complexity are contingent upon the type of study being conducted.

RCTS designs protocols in adherence with International Conference of Harmonization (ICH) and good clinical practice (GCP) guidelines, which necessitates clear definitions and explanation of the following information:

  • General information
    • Sponsor, investigators and testing facility
    • Hypothesis and objectives
    • Primary and secondary endpoints, if any
  • Population
    • Subject selection criteria for inclusion and exclusion
  • Methodology
    • Study design, test articles and subjects
    • Detailed description of trial procedures
    • Efficacy and safety assessments and variables
    • Adverse events reporting information
    • Quality assurance
    • Confidentiality, record maintenance and retention
  • Study plan
  • Statistical analysis
  • References and publications