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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
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On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and institutional review boards (IRB) define, identify, and report protocol deviations.
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The Health Research Authority (HRA) announced that England and Wales have begun implementing changes to their clinical trial regulations on June 1st, 2024. These changes include the removal of the requirement for trials to submit annual progress report to their Research Ethics Committee (REC) and the process of submitting safety reports. Scotland and Northern Ireland, following review, also implemented these changes to their regulations making the updates now applicable in all four of the UK nations as of August 1st, 2024.
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The U.S. Food and Drug Administration (FDA) announced that the “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” draft guidance is available for comment. When finalized, the draft guidance fulfills the requirement for guidance on decentralized clinical trials under Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA).
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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline for ICH E6(R3) Good Clinical Practice, which reached step 2 on May 19, 2023 and is open for public consultation. This draft includes the GCP Principles and Annex 1, and updates to Annex 2 of the guideline are now underway.
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The US Food and Drug Administration (FDA) released a draft guidance “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers” in March 2023. When finalized, it will replace the 2007 guidance “FDA Computerized Systems Used in Clinical Investigations.” The FDA regulates electronic systems, electronic records, and electronic signatures used by sponsors and CROs to create records required for clinical trials per 21 CFR Part 11.
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The US Food and Drug Administration (FDA) released a final questions and answers guidance document, “A Risk-Based Approach to Monitoring of Clinical Investigations” in April 2023. It includes recommendations for developing a monitoring approach and the content of the monitoring plan, and follow up and communication of the monitoring results. The questions and answers guidance is a companion to the “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” guidance from August 2013.
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Decentralized clinical trials (DCTs) have increased in popularity during the pandemic. The US Food and Drug Administration (FDA) released guidance on Conduct of Clinical Trails of Medical Products During the COVID-19 Public Health Emergency that clarified that decentralization of clinical trials through remote collection of data outside of a physical location is permissible as long as methods follow regulatory requirements.
