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?
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Partners Human Research Quality Improvement Program
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!