Question

Cross-Sectional and Clinical Trial Study Designs

You are a newly hired assistant professor at a teaching university and you wish to conduct a clinical trial examining the efficacy of a new, FDA-approved Ebola vaccine. You will be examining the immunological response in your study participants. Also,assume the vaccine has been through FDA trials and is approved for use in the general population: normal, healthy adults ages 18–65. Discuss the steps you would take as the principle investigator to get your study started, and address the following questions:

What paperwork would need to be submitted?

From which boards or committees would you need to seek review and approval?

What are some of the regulatory requirements for your study you would need to prepare and provide for?

Answer 1

To get the study started, the investigator has to first prepare a research proposal which includes:

• A brief introduction to the topic and background of the study, and a brief discussion on the need for the study.
• Research problem statement, aim and objectives
• Methodology of the study with details of research design, sample size, sampling technique, description of the clinical trial process, budget for the study, timeline, and data analysis.

The research proposal is submitted to the Institutional Review Board and ethics committee for approval.

In addition, the investigator has to prepare the informed consent forms, procurement plan for the vaccine, it's storage, and safe use, plan to treat any adverse effects of the trial, the detailed financial disclosure and undergo any training as required for the study.