The subject source should document when the site was notified and how the site was notified of the serious adverse event. This information is needed to verify that the site is compliant with the requirement to report serious adverse events within 24 hours of notification to the sponsor.

The informed consent discussion should always be documented in the subject source. It is important for it to be noted that study procedures were not performed until after the informed consent was signed and that the subject was given a signed copy of the informed consent.

Ensuring that the data is not obstructed is critical to maintaining the audit trail. A good rule of thumb to remember is the ALCOA guideline. Data should always be "attributable, legible, contemporaneous, original and accurate." Anyone should be able to review the data and understand the flow of events. It is always best to err on the site of caution and provide documentation for any event that may pose a question later. If everyone follows these guidelines, we can ensure the integrity of the data.