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.
Automated test execution tools can be used to improve efficiency and effectiveness. Like other software, test automation software may be standard, configurable, or custom, and should be specified and verified appropriately based on an assessment of risk; however, auditors frequently note that GxP software developers do not assess these tools […]
After the selection of a vendor, appropriate contracts should be put in place prior to the commencement of work. Contracts should clearly detail the delegated tasks, duties and functions between the parties, and the required standards of service.
All the guidance documents published by the Regulatory Authorities during the COVID-19 Pandemic, highlight the need for risk assessments to be conducted by the clinical trials sponsors and Clinical Research Organizations (CRO). However, conducting risk assessments and developing adequate Risk Management Plans are not easy tasks. This article pretends to […]
Based on recent inspection findings, the GCP Inspectors Working Group (IWG) and the Committee for Medicinal Products For Human Use (CHMP) recognize the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial […]