Question

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.

Answer 1

The integrity of the clinical studies can be ensured even when you have not followed (or cannot show that you have followed) the required protocols for good research by formulating a proper report and covering all the aspects and information in the report as per standard protocol. The results can definitely be obtained again and corrective measures can be taken even when the required protocols have not been followed. Hence it must always be ensured that all aspects of clinical studies are ascertained and proper procedures and guidelines are followed at all times.