Clinical Research Guidelines and Tools

Clinical research is the scientific study of human health and disease to develop new medical treatments, interventions, and health practices. It involves the systematic study of drugs, medical devices, behavioral interventions, and public health strategies to assess their safety, efficacy, and impact on individuals and populations.

Clinical research can be categorized into:

  • Interventional Studies (Clinical Trials): Research involving participants who receive specific treatments or interventions to evaluate their effects.
  • Observational Studies: Studies that assess health outcomes in groups of people without assigning specific interventions (e.g., epidemiological studies, cohort studies).
  • Behavioral and Public Health Research: Investigating how behaviors, social factors, and public health initiatives influence health outcomes.

Clinical research follows ethical and regulatory standards to protect participants, ensure data integrity, and contribute to evidence-based medicine and public health policies.

The Office of Research & Innovation (ORI) continues its efforts to provide best practices, enhance collaboration, and reinforce our commitment to Drexel University and our Research Community. As part of these initiatives, ORI is releasing an initial set of Clinical Research Guidelines and Tools to encourage best practices in line with applicable regulations, procedures, and Good Clinical Practice (GCP). Additionally, future guidance and resources are also mentioned, including both Drexel and Non-Drexel resources. Non-Drexel resources are available for reference but should be assessed prior to use based on the specifics of the project and other applicable regulatory requirements as well as University policies, procedures, and requirements. These resources will be updated and expanded throughout 2025 and 2026.

Please note that your funder or sponsor may have different templates or forms that are required to be used, so please refer to the terms and conditions of your award.

Clinical Trial Process Map

View the text version of the Clinical Research Guideline and Process Roadmap

Step 1: Design and Planning 

Step 2: Start-Up 

Step 3: Conduct and Monitoring 

Step 4: Analysis, Reporting, and Publication 

Step 5: Closeout