Gerald L. Klein, MD and Roger Morgan, MD
PROMPT RESPONSE TO INVESTIGATOR SITE QUESTIONS
Answering questions about inclusion and exclusion (I/E) is an important function of the medical monitor.
A prompt response is necessary if the patient is waiting to be screened.
A clear explanation of your response
Document with the specific I/E criteria
Provide clear documentation for the Trial Master file/investigator and, if appropriate, furnish a reference article from the medical literature
If patient safety is involved, providing a quick response is crucial.
Examples of when a quick response is necessary:
Suspected Unexpected Serious Adverse Reaction (SUSAR)
If a question about the necessity of unblinding occurs
Serious adverse event that triggers the study to be stopped
A safety issue that needs to be discussed immediately with the site and or sponsor
It is important to have a backup medical monitor in place to provide this service continuously.
Provides coverage for holidays, vacations, or sick days
PROVIDING MEDICAL REFERENCES
Why provide medical or regulatory references?
To foster greater understanding of the entry criteria
To help the sites form better decisions in the future
To create mutual respect between the sites and the medical monitor
To help with better regulatory understanding of the study
ANSWERING QUESTIONS
All questions from the sites should be added to a Question and Answer log (Q&A) and made available to other monitors who may be on the study as well as to clinical operations personnel.
This will ensure consistency and will help address future questions that are similar
Help the site decide about entrance criteria
May clarify some common questions that sites may have
Promotes minimization of protocol deviations