MORIAH Consultant's Blog

Form 1572 Update May 21, 2021

On May 20, 2021 the FDA released a Draft Guidance on updates to the previous guidance on the use of the Form 1572, Statement of Investigator. In particular, the draft addresses issues around the use of the form for Investigators outside of the US and waivers to the need for ex-US Investigators to sign the form.

https://www.fda.gov/media/148810/download

Role of Training for Clinical Trial Professionals November 10, 2020

Check out my recent comments featured on the ACRP webpage Blog, authored by their Editor Michael Causey. In the posting on how ‘Training must evolve to better serve clinical trial professionals’, I discuss recent trends and considerations, especially in current pandemic and how we have had to adjust to this new environment. Read the full posting here at:

August 17, 2020

The FDA has released their final guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff (August 2020)”.  This guidance finalizes FDA’s plans for civil monetary penalties for certain violations of the listing requirements related to the Clinicaltrials.gov database.  Since 2007 the FDA and Public Health Service have required a sponsor of a study to submit registration and results information to the publicly accessible database for ‘applicable clinical trials’.  This was codified in 42 CFR §11, finalized in 2017.

The new guidance provides details for how FDA intends to handle the implementation of the penalties for failures to follow the regulations regarding clincialtrials.gov.  The FDA has the oversight and enforcement authority under the regulations,  Generally, the Centers intend to identify violations of the FD&C Act’s requirements relating to the ClinicalTrials.gov data bank through evidence collected during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO).

When a Center believes that a responsible party for an applicable clinical trial may have committed a prohibited act the Center generally intends to send the responsible party a Preliminary Notice of Noncompliance (Pre-Notice) Letter, which describes the potential violation and requests that the responsible party take any necessary actions to address the potential violation within 30 calendar days after receiving the letter.  After the Letter is sent, a sponsor has defined time periods (listed in the guidance) to respond by either correcting the violation or appealing.  The guidance further describes the appeal and review process and how FDA will handle the final adjudication of any violation.

The statutory maximum penalties under the FD&C Act for committing these prohibited acts are not more than $10,000 for all violations adjudicated in a single proceeding and, if a violation is not corrected within 30 days following notification of such violation provides for an additional civil money penalty of not more than $10,000 for each day that the violation continues after such period until the violation is corrected.

Medical Device Clinical Trials August 4, 2020

The International Organization for Standardization (ISO), a network of national standard bodies that develops voluntary standards, has recently released a new, revised version of their global clinical research standard; ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice.  The ISO 14155 has been updated to the third edition and released in July 2020.  The previous version was released in 2011.

ISO 14155 addresses GCP for medical device studies including the design, conduct, recording, and reporting of clinical investigations. This new edition strengthens the risk management requirements across all phases of the clinical investigation process, including pre- and post-market clinical investigations.   If you would like a copy of the new ISO standard, check out the ISO webpage.

Unlike ICH and FDA Guidance documents, ISO standards need to be purchased for use.

FDA Inspection Procedures July 29, 2020

The FDA recently issued an updated version of the Compliance Program Manual for the inspection of Clinical Investigators and Sponsor-Investigators (7348.811).  This update was issued on July 22, 2020.  The Compliance Manual was last updated in December 2008.  The latest version can be found at:  https://www.fda.gov/media/75927/download.

Data Integrity in Clinical Trials July 3, 2020

In October 2018, the MHRA and FDA held a 2-day event in Washington, where MHRA  and US FDA GCP Inspectors joined forces to discuss data integrity.  As an outcome from that meeting, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.

https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.1794

If you are having trouble obtaining a copy of the article, contact the Corresponding Author at FDA and request one.

Free eConsent App June 5, 2020

The U.S. Food and Drug Administration (FDA) is offering its FDA MyStudies app to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials, when face-to-face contact is not possible or practical due to COVID-19 control measures. The agency said it “is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in healthcare facilities or could not travel to outpatient clinics.”

Through the App (available as iOS or Android), the investigator can send the informed consent document electronically to the patient or his or her legally authorized representative. Once the patient or representative has signed the form, he or she will receive an electronic copy. The investigator can then access the signed consent in a secure manner and print it or transfer the file electronically.  To facilitate free use of the app during the public health emergency, FDA intends to fund this assistance as resources permit.

Clinical Trials During the COVID-19 Pandemic May 26, 2020

Back in March 2020, at the beginning of the intense lock down due to the coronavirus pandemic, the FDA published a guidance on the considerations for the conduct of clinical trials during the public health emergency.  In addition to some general information, the guidance includes some Q&A at the end on some important questions regarding the conduct of clinical trials during the pandemic.  This guidance has been updated several time since the original publication with additional Q&As added (www.fda.gov/media/136238/download).  The most recent updated is now dated June 3, 2020.  If you are involved  in the conduct of clinical trials and have questions on how to proceed during this time, consult the document for helpful information.

Human Research Requirements April 29, 2020

The Office for Human Research Protections (OHRP), has released their 2020 edition of the International Compilation of Human Research Standards.  This document is available on their webpage at: https://www.hhs.gov/ohrp/sites/default/files/2020-international-compilation-of-human-research-standards.pdf

The List compiles more than 1,000 laws, regulations, and guidelines from 133 countries. These Standards are applicable to stakeholders in clinical research globally, including sponsors, investigators, and Ethics Committees.  The International Compilation of Human Research Standards, as in the past, is organized in a table format and is searchable by topic and country, with hyperlinks to the legislation, regulation, guideline, or key organization.   It is not an exhaustive list of all current standards or countries where research may take place, but the Compilation is a valuable resource for stakeholders in clinical research to locate relevant laws, regulations, and guidelines and to compare standards across the world within one cohesive document.  The list is updated every year by OHRP with new details and additional countries as more information is collected.

OTC User Fees March 28, 2020

During these challenging times in the middle of the Covid-19 crisis, it is important to note a major change that will be coming to FDA. One of the many ‘extra’ provisions added to the CARES Act, is the passage of User Fees for Over-the-Counter (OTC) drug products. This is something that FDA and the industry has been discussing and seeking for several years. Details are not available yet as to exactly how this will be implemented and what it will mean to the struggling Monograph process that has been in process since 1972!

More details to follow.