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New Draft Guidance on Protocol Deviation ...

01/21/2025

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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.

New Draft Guidance on Protocol Deviation Management Part 2/2
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ICH E6(R3) Progresses into Step Four

01/15/2025

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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).

ICH E6(R3) Progresses into Step Four
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New Draft Guidance on Protocol Deviation ...

01/14/2025

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On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and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.

New Draft Guidance on Protocol Deviation Management Part 1/2
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Implementing the New UK Clinical Trials ...

01/07/2025

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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.

Implementing the New UK Clinical Trials Regulations
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ICH E6(R3) Annex 2 Draft Version is Now ...

12/23/2024

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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.

ICH E6(R3) Annex 2 Draft Version is Now Available!

Concerning Violations: Sponsor-Investigator Warning Letters

11/09/2021

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There are two recent warning letters relating to sponsor-investigators. (warning letter 1 HERE and warning letter 2 HERE). A sponsor-investigator both initiates and conducts a clinical trial, which is also known as an investigator initiated clinical trial (IIT). In both examples, the investigator used protocols internal to the institution but did not submit an Investigational New Drug (IND) application to the FDA. The drugs chosen for the protocols were approved and being used for on label use in the protocols. However, the protocols restricted what drug was being used and so could not be considered standard of care.

IRB Review Still Needed for Deidentified Specimens

11/02/2021

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The US Food and Drug Administration (FDA) wrote a letter to industry, “Studies Using Leftover, Deidentified Human Specimens Require IRB Review.” It is a reminder to in vitro diagnostic medical device sponsors that Institutional Review Board (IRB) review is needed for clinical trials on leftover, de-identified human specimens. The 2006 FDA guidance “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” clarifies that informed consent to use leftover human specimens that are not individually identifiable is not required, if it meets exemption criteria from the Investigational Device Exemptions (IDE) regulation (21 CFR 812.2(c)(3)).

Comment Now! RWE Using Electronic Health Record and Medical Claims Data Draft Guidance

10/26/2021

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The US Food and Drug Administration (FDA) released a draft guidance on “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products.” This draft guidance is published in line with the 21st Century Cures Act (Cures Act). Part of the Cures Act is related to the use of real-world evidence (RWE) to help support the approval of a new indication for an approved drug or to support post approval study requirements.

Now Available for Purchase: HIPAA Training for Clinical Trial Professionals

10/19/2021

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HIPAA's requirements for the use and disclosure of Protected Health Information (PHI) during the conduct of a clinical trial is not simple and depends on the situation. But there is a way to use a core set of principles and questions that provide an ability to manage and facilitate the needs of all stakeholders. The regulatory authority of HIPAA, the OCR and FDA, agree that the two sets of regulations do not conflict and work well together. HIPAA does not restrict the GCP requirements of a site.

To purchase to to view an interactive demo, visit our online store HERE.

Comment Now! FDA Draft Guidance on Investigator Responsibilities for Safety Reporting

10/12/2021

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The US Food and Drug Administration (FDA) released a draft guidance, “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices” in September 2021. It combines recommendations from the 2009 procedural final guidance, “Adverse Event Reporting to IRBs - Improving Human Subject Protection” and the investigator responsibilities for adverse event reporting portion of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies”. This draft guidance clarifies how investigators can comply with their regulatory safety reporting requirements and understand when safety data may show reportable issues including serious adverse events (SAEs) or unanticipated adverse device effect (UADE).