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Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More
The FDA has dinged a clinical investigator in a warning letter for failing to conduct an investigation, according to the investigational plan. Read More
As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More
A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More
The U.S. FDA’s device center is taking steps to improve the predictability of IDE reviews with the establishment of a new director-level position to oversee the clinical trials in the Office of Device Evaluation, a center official says. Read More
The ayes had it with the House Energy & Commerce Committee May 21, with all 51 members voting to pass the latest version of the 21st Century Cures Act. Read More
Sponsors should decrease their use of on-site monitoring in clinical trials in favor of more centralized, risk-based methods that can be largely conducted remotely, an expert says. Read More
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