ICH GCP

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 […]
March 20, 2020

Updated Guidance on Clinical Trials Management & COVID-19

This article pretends to follow-up a previous publication we did covering the initial guidance that was provided by some of the European National Competent Authorities (NCA) with regards to the COVID-19 outbreak. Since the situation keeps evolving, almost every day we have been notified by different media that another Competent […]
March 16, 2020

Clinical Trials Challenges in relation to COVID-19

The COVID-19 dissemination is highly impacting the lives of all of us, personally and professionally and we still do not know how this situation will progress and when we could go back to normality. Working on clinical research, we need to keep on working to safeguard first the safety and […]
March 11, 2020

Things You Need to Know About Delegation of Responsibilities in Clinical Research

Delegation of responsibilities related to a clinical trial is an area that is not always properly understood by the investigators. Incidents with the completion and maintenance of the Delegation Log are repeated over and over across all the research sites which suggest that the investigators did not receive appropriate training. […]
You’re Just Seconds Away From The Essential GCP Training & Advice JOIN TODAY