Data Integrity

Expert: Clearly Define Roles Of the Central IRB

Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More

FDA, DOJ Pursuing Cases of Clinical Trials Fraud

The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More

EMA Wants to Revise Quality Documents

Some of the European Medicines Agency’s current recommendations on documenting quality standards for investigational medications will soon be out of date, as the Clinical Trials Regulation comes into effect next year. Read More

EMA Issues Guideline on Covariates in Clinical Trials

Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments. Read More