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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On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and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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Beginning January 31, 2023, the Clinical Trials Information System (CTIS) is required for all new clinical trial applications that are applicable to the European Medicines Agency (EMA). The Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) entered into application January 31, 2022, which also launched the CTIS.
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The ICH Q9(R1) international guideline on Quality Risk Management reached step 4 on January 18, 2023. Step 4 is when the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory Members of the ICH Assembly have adopted the guideline as a harmonized guideline.
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The European Union, excluding Great Britain, regulates medical devices under the Medical Device Regulation (MDR) (Regulation EU 2017/745) which entered into force May 2017 and into application May 26, 2021 with a three year transition period. The MDR application date was originally planned for May 2020 but was delayed for one year due to the pandemic.
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The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. Several of the questions were previously revised in March 2022. Under section “GCP matters”, questions 16 and 17 were added in late 2022. Question 17 is covered in part 2 of the blog.
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An investigator was recently issued a warning letter due to noncompliance with the IRT, which can impact the safety of the participants and the quality and integrity of the data. Per protocol, IP was to be administered according to hemoglobin levels and the IRT was to randomize the doses appropriately.
