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New Final Guidance Q&A on RRAs

07/08/2025

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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.

New Final Guidance Q&A on RRAs
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BIMO Finds Objectionable Conditions During ...

06/23/2025

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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.

BIMO Finds Objectionable Conditions During Inspection
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FDA shares FAQs on IRBs

06/17/2025

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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.

FDA shares FAQs on IRBs
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Final Guidance Released on IRB Written ...

06/03/2025

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In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”

Final Guidance Released on IRB Written Procedures
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Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

Considerations for Site eConsent Adoption

4/2/2018

Informed Consent is the process of ensuring the subject’s understanding of the study prior to enrollment, and eConsent may be one step in that process. Not only is Informed Consent a regulatory requirement for subject safety, but well-informed subjects are more likely to enroll and remain compliant, positively affecting enrollment numbers, reducing study costs, and protecting data integrity. eConsent supports the site’s efforts in fully informing subjects. As eConsent gains in popularity, it is important to understand some key benefits and considerations prior to adoption.

27 Social-Behavioral Research (SBR)

3/29/2018

The U.S. Department of Health & Human Services (HHS), has posted a new listing of 27 social-behavioral research laws and regulations recently on their website. The standards posted were developed in several countries around the world like Australia, Canada, France, India, Saudi Arabia, South Africa, Taiwan, and the United States (U.S.). One of the regulations issued was implemented by the United Nations Educational, Scientific and Cultural Organization (UNESCO) and they must be followed by any site conducting a study being funded by the governmental agency. 

FDA Released ICH E6(R2) Guidance!!!

3/6/2018

On February 28, 2018, the FDA released E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry, which can be found here. Other than a few minor clerical differences, the guidance was implemented in entirety from the ICH E6(R2) Addendum, which can be found here. The notice of the draft guidance was published in the Federal Register on September 29, 2015 and was open to comments until November 30, 2015. The final draft was submitted to ICH Assembly and the regulatory agencies endorsed it in November 2016.

Upcoming Webinar on Monitoring Considerations for Clinical Trials Using eConsent – March 8th

2/8/18

Join us Thursday March 8th as Deborah, Elizabeth and SAM discuss the benefits of integrating eConsent into your consenting process as well as the benefits it has on monitoring and data integrity.  Sponsors have the responsibility of ensuring all subjects have been properly consented and which requires onsite visits from the sponsor’s monitor to manage the informed consent process.  These 3 are experts in informed consent and have decades of monitoring experience between them and will speak on the advantages of eConsent from their own personal experiences as well as the challenges they have encountered throughout the years.