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EMA on the use of Real-World Data/Evidence in ...

04/30/2025

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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies
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FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).

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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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IRB Warning Letter from BIMO Inspection

03/10/2025

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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.

IRB Warning Letter from BIMO Inspection

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FDA IND Safety Reporting: New Draft Guidance

6/29/2021

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The US Food and Drug Administration (FDA) released a draft guidance “Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” The draft guidance is a combination of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies” and an updated version of the draft guidance from 2015, “Safety Assessment for IND Safety Reporting,” which has been withdrawn. The intent of the draft guidance is to clarify and support sponsors in understanding the requirements for expedited safety reporting.

FDA Takes Action on Unreported Study Results; First Notice of Noncompliance

5/18/2021

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The US Food and Drug Administration (FDA) requires sponsors to register and report results to ClinicalTrials.gov (Clinical Trials Registration and Results Information Submission Final Rule). The purpose of listing and reporting in the public database is to increase transparency and increase scientific understanding, thus allowing others to build on knowledge already gained rather than duplicating work that may be unnecessary. If these requirements are not met, the FDA has authority to take enforcement action.

Redacting Source Data in Remote Monitoring: Common Myths

4/21/2020

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Myth: Source data needs to be redacted before it can be reviewed by a monitor for remote monitoring.

Answer: The question is, why would you redact when the patient gave authorization to use and disclose the information for the purposes laid out in the authorization and consent? Remote review is not “collecting” data; it is “reviewing” data. Also, redacting is super laborious, manual, and prone to errors.

UPDATE to Appendix FAQ: FDA’s COVID-19 Clinical Trial Guidance

4/17/2020

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The FDA released new topics in the FAQ section of the guidance document for conducting clinical trials during the COVID-19 pandemic. The rapidly changing environment of the crisis has made it challenging to continue conducting and monitoring clinical trials in the traditional manner due to restrictions on travelling, dispensing investigational products, and social gathering. New questions continue to arise as the logistics of monitoring and conducting clinical trials become apparent.