Have questions about FDA 1572s?
FDA has updated its guidance documents for 1572s.
Don't worry, if the FDA 1572 seems confusing, you are not alone. In fact, the FDA updated its Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs--Frequently Asked Questions Statement of Investigator (Form FDA 1572)
The document was posted in July 2008, but according to an Applied Clinical Trials Editorial Advisory Board member believes with the myriad of
activities that clinical operations staff are responsible for some seem to have "missed" this update.
Also, a previous Applied Clinical Trials article on the subject could provide more help.
How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial Research
July 24th 2020While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
