Literature reviews play a big role in upcoming European Union regulatory requirements involving clinical evaluation reports (CERs) set to go into effect in 2020, and Evidence Partners has offered some advice on getting a solid foundation.
Per an Evidence Partners blog post, literature reviews are used to:
- Identify and evaluate safety and performance data;
- Establish state of the art; and
- Monitor risks and reconfirm device risk profile.
“With regulatory bodies increasing their scrutiny of literature reviews and CERs in general, many organizations are looking for new ways to consistently deliver regulatory compliant, audit-ready literature reviews on time and on budget,” the post’s author, Dr. Isabella Steffensen, says.
The No. 1 tip to strengthen literature reviews, she says, is the PICO framework.
To read on about the PICO framework and how to produce stronger literature reviews, click here.