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

This step focuses on designing and developing the study’s research question (e.g., PICO, 3R’s of Research) and outcomes. A well-designed clinical trial involves careful planning across several key areas. This includes selecting an appropriate study design, calculating a sufficient sample size to detect meaningful effects, and developing a detailed protocol outlining objectives, methodology, and safety measures. Effective trial logistics, including budget and data management, ensure the study runs smoothly and generates reliable results.

Future guidance and resources include: Feasibility, Budget Development, Medicare Coverage Analysis.

Step 2: Start-Up

Study start-up is a critical piece in a clinical research study, involving several key tasks to ensure the study is ready for execution. Study start-up includes site initiation activities, training personnel, setting up systems, and ensuring the site is prepared for participant enrollment through the establishment of delegation of authority, regulatory file maintenance, and ongoing compliance and regulatory requirements. These steps ensure the project is properly equipped to begin and remain compliant.

In addition to the below, future guidance and resources include: Clinical Trial Agreements, Insurance/Indemnity, ClinicalTrials.gov Registration.

Step 3: Conduct and Monitoring

During a clinical research study's conduct and monitoring step, ongoing oversight ensures that the study adheres to the protocol and regulatory requirements. Regular monitoring visits and data reviews are conducted to verify the accuracy and completeness of collected data, participant safety, and compliance with requirements; this includes any data safety monitoring boards or plans being completed as required or approved. Any deviations, adverse events, or issues are documented, addressed promptly, and reported to the IRB, funding agencies, or others as required. Monitoring also includes checking the informed consent process, ensuring proper management, and maintaining the integrity of regulatory files. These activities help ensure the trial’s quality, participant safety, and reliable outcomes.

In addition to the below, future guidance and resources include: Monitoring, Financial Management, ORI Quality Assurance.

Step 4: Analysis, Reporting, and Publication

The analysis and reporting step involves evaluating the study data to assess treatment safety and efficacy. Based on the study plan, statistical analysis is conducted, focusing on primary and secondary endpoints. Results, including any adverse events, are compiled and shared with stakeholders, regulatory bodies, and the scientific community. This ensures transparency and contributes to medical knowledge.

Future guidance and resources include: Clinical Trial Reporting and Data Sharing.

Step 5: Closeout

Study close-out marks the final step of a clinical research study, ensuring all activities are completed and documented. This includes final data verification, resolving outstanding queries, and securely archiving regulatory files. Investigational sites are formally closed, and participants are informed of the study’s conclusion as applicable. This process ensures the study is properly concluded and the data is secure for the clinical and scientific record as applicable.

In addition to the below, future guidance and resources include: Research Document Retention and Disposal.

NIDCR Study Completion & Close-Out Documents