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The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More
The U.K.’s Information Commissioner’s Office published a draft guidance on obtaining informed consent, ahead of stricter European Union regulations on data protection that take effect in May 2018. Read More
An NIH center announced that all clinical trial sites participating in its grant program have agreed to use a single institutional review board for each multi-site study. Read More
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More
The FDA has released final guidance on assessing the risks and benefits of investigational device exemption applications for human clinical studies. Read More
Last year’s 21st Century Cures Act directed federal agencies to pursue an international pediatric clinical trials network, and to engage with foreign regulators alongside attempts to align international guidance. Read More
Clinical research organizations and pharmaceutical companies are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More