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.
September 1, 2020
Automated Testing

Lack of Assessment of Automated Test Execution Tools

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 […]
May 19, 2020

Validation and Qualification of eClinical Systems (2) – Contracts/Agreements

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.
May 14, 2020

Clinical Quality Risk Management

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 […]
May 13, 2020

Validation and Qualification of eClinical Systems (1)

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 […]