Partners Human Research Quality Improvement Program QUICK BITE Series. More Work is Less Worry. Guidance to Lessen Regulatory Concern. Sarah White,QI/QA Specialist [email protected] March 10, 2005. More Work is Less Worry. To work, or not to work What are we worrying about?
QUICK BITE Series
More Work is Less Worry
Guidance to Lessen Regulatory Concern
Sarah White,QI/QA Specialist
March 10, 2005
Site A has worked hard to put systems in place to manage their hefty research study load
* Versus *
Site B jumped right into their research studies and took on the attitude of handling things as they come up
**Both sites are very successful at enrolling and completing their subjects.
Both Sites A and B are called by the FDA and told they will be audited. The FDA auditors will arrive at their offices at 9 a.m. the following day. Of particular interest, the FDA would like to see subject enrollment records and drug accountability records.
Site B is in for a long day (and night) creating an enrollment log and accounting for drug disposition of their 237 subjects!
Up all night cleaning up files
FDA warning letter
Study deferral and/or expiration
subject safety/data integrity
Systems should be:
There will be unexpected consent form changes during the course of the study
Don’t dismiss reminder!
“Share Our Stories – Case Studies from the Field”
Do you have a case study or story that you’d like to share? The QI Program is welcoming case studies to include in our next lecture. Please contact Sarah White ([email protected] / 617-424-4137) if you have a case study that will help others in the research community learn!