You are the Principle Investigator of a double-blind, randomised controlled trial that compares the efficacy of herbal supplement X to an active control (oral antihistamine) in relieving symptoms of allergic rhinitis. Your study is sponsored by the company that manufactures herbal supplement X.
Instructions
In the subsequent pages, you will be presented with three different scenarios. For each of the scenarios, you will be asked to consider the following:
- Whether an AE / SAE has occurred
- What could have caused it
- What could have prevented it from happening
- How was it identified and whether you could have detected it earlier
- How will you manage it
- How will you document it
- Who will you report it to