2. Setting: The case of missing forms

Topic/Law:Clinical trials...informed consent....missing date...torts

You are a senior clinical researcher.You are compiling the reports for a Phase II clinical study.S team member at one of the research sites reports that the informed consent forms have been lost.The informed consent forms are essential if the results are going to be included in the study.Further, if the forms aren't kept properly, the FDA can censure the company.

Issue:How to ensure the integrity of the clinical studies when you have not followed (or cannot show that you have followed) the required protocols for good research.