GDPR, Data integrity, Clinical Research and YOU:

Perhaps you have been hearing a lot about the new EU data protection law, the GDPR, which is set to become effective in May 2018—only a few months from now? If you . . . run global clinical trials with investigator sites in the EU provide outsourced services for global clinical trials with investigator sites […]

Inspection Readiness – A Marathon, Not A Sprint

In order to respond successfully during an FDA, EMA, MHRA, PMDA or other health authority inspection, a program of continuous inspection readiness is required. One-off sprints to prepare are not very likely to be sufficient, even for very experienced personnel. An effective inspection readiness program is a sustained effort spearheaded by a broad-based team composed of […]

Root Cause Investigation – Foundation of CAPA

Effective root cause investigation is the key to designing and implementing effective corrective actions restoring data integrity and full regulatory compliance. Conducting an effective root cause analysis requires a commitment to delve deeply enough into the pattern of facts that comprise an incident that one reaches a point at which what, when, who, and how […]

ICH E6(R2) – Addendum Highlights/CSV & Data Integrity

The Integrated Addendum to ICH E6(R1): Guideline to Good Clinical Practice E6(R2)  was finalized in November 2016. The Integrated Addendum is a significant update to the 20-year-old ICH GCP Guideline originally adopted in 1996. The ICH website states: “This guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, […]

ICH E6(R2) – Addendum Highlights – Risk

The Addendum as finalized in November 2016 specifically calls out the need to asses and address the risks a system poses to the correct and complete collection of data and the ability to maintain the integrity of those data over time. E6(R2) requires that a complete and accurate risk assessment be conducted and properly documented […]

Greatest Risk to Data Integrity – People

While technical controls and effective computerized system validation are clearly essential to establishing and maintaining data integrity for electronic systems, the greatest risk is still the behavior of the people who use and maintain systems, including infrastructure and databases. Training is an important starting point, but it is important to move beyond reliance on training […]

eSource – Meeting Regulatory Expectations

eSource is the term used to denote data that are  generated or captured directly from digital sources such as instrumentation or electronic health records or that are acquired by other electronic means, including transcription by an operator from any source documents, including but not limited to paper documents. Both FDA and EMA have issued detailed […]

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