Incorrect Use Of Reference Safety Info Still An Issue, Says UK MHRA
UK good clinical practice inspectors are continuing to detect critical shortcomings relating to clinical trials safety and the management of reference safety information.
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An EU guideline on the complex subject of how drug sponsors should present and manage the reference safety information in their clinical trial applications is nearing finalization. For the past several months, drug companies have been grappling with an increased regulatory focus on RSI, which has resulted in their trial applications being rejected or studies being significantly delayed.
Sponsors of clinical trials in the EU have recently been inundated with objections from regulators for incorrectly managing their clinical trial reference safety information, which in turn has resulted in these trials being significantly delayed. A UK MHRA inspector discusses some of the common issues identified during inspections on this front.
EU regulators are increasingly raising objections over the reference safety information that companies include in their clinical trial applications and updated investigator's brochures.