October 29, 2020

Things you need to understand about Reference Safety Information

The Reference Safety Information (RSI) is used for the assessment of the expectedness of all ‘suspected’ Serious Adverse Reactions (SARs) that occur in clinical trials (CTs). Major and critical findings related to pharmacovigilance are often raised during regulatory inspections and the root cause for these finding is normally linked to […]
October 26, 2020

Trial Master File: E-Mail Communications in Clinical Studies

Communications associated with key decision making and trial conduct is commonly an area raised as deficient during GCP audits or inspections. The communication section in the (e)TMF frequently lacks the relevant e-mail threads.