How to Prepare a Final Study Report for a Clinical Trial

Clinical trials are studies carried out to answer specific questions about vaccines, medicines, or new ways of using known treatments. A final study report for a clinical trial requires accuracy and precision, so it takes a long time to prepare and write. The report includes clinical and statistical descriptions, as well as presentations illustrated by tables and figures.

Things You'll Need

  • Case Report Forms
  • ICH Study Report Templates
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Instructions

    • 1

      Compile all the collected data in a central location. Clinical trials generate large amounts of both hard copy and soft copy data. Organizing these in a central location will make it easy for you to access information when you need it. Confirm that you're working with well-documented data that will ensure the accuracy of your final report and save time, too.

    • 2

      Use the clinical protocol as a guide for documenting the final report of the clinical trial. A protocol is prepared at the initial stages of a trial. It acts as a guide to show the reviewer that the writer of the report followed the methodology, design and objectives of the trial. A protocol maximizes the validity of the results the writer documents in the final study report.

    • 3

      Pay attention to the standards developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH standards are benchmarks that several countries, including the United States, have adopted. They serve to standardize the content and structure of clinical reports for practitioners in these countries. Prepare an ICH compliant report to increase the scientific quality of your work. Check the ICH-E3 regulations to find out the requirements for producing a report that complies with these standards.

    • 4

      Review your report. After taking into consideration all the above steps and writing your report, check for any mistakes. Ensure that the graphic presentations and statistics are accurate. Remember to attach the protocol, and any amendments to it, to the final report.

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