Resources and Tools

Did U Know

Did U Know September 2020 -
FDA released their Guidance on August 2020, detailing processes on enforcing civil monetary penalties of up to $10,000/day for studies not meeting the requirements to the data bank?

Did U Know August 2020 -
for all research conducted at JHS you must submit a copy of the signed Informed Consent/HIPAA Form B within two business days to the JHS Clinical Trials Office

Did U Know June 2019 -
using FDA Approved Drug, Device, or Biologic as an intervention is considered a ClinicalTrail

Did U Know April 2019 
the effectiveness of the CAPA plan is proportionally related to the level of the root cause analysis conducted by the research team?