TMF

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 […]

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.