-
Jan 14, 2025 | 
jdsupra.com | Eman Al-Hassan |Robert Church |Heidi Forster Gertner
FDA defines a protocol deviation as a “generally unintentional” departure from IRB-approved protocol, noting they are commonly not discovered until after they occur. For example, an investigator’s failure to perform a protocol-required test being discovered by the study monitor during a routine monitoring visit would be a protocol deviation.
-
Apr 22, 2024 | 
jdsupra.com | Eman Al-Hassan |Robert Church |Heidi Forster Gertner
The C3TI demonstration program is an excellent opportunity for pharmaceutical and biotechnology companies to closely interact with FDA and have meaningful input into the agency’s policy-making on clinical trial innovation. As such, we strongly encourage our clients to consider applying for this program.
-
Mar 12, 2024 | 
jdsupra.com | William Ferreira |Heidi Forster Gertner |Randy Prebula
The draft guidance provides recommendations on how to present key information at the start of an informed consent process, which should include topics that are generally important for clinical trial participants to understand, including: the purpose of the research, the possible risks and benefits of the study, and the study’s length and procedures.
-
Mar 11, 2024 | 
lexology.com | Heidi Forster Gertner |Bill Ferreira |Randy Prebula |Yetunde Fadahunsi |Will Tenbarge
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) published new draft guidance on how to present key information at the beginning of an informed consent document.
-
Mar 4, 2024 | 
law360.com | Rob Church |Heidi Forster Gertner |Blake Wilson
ADVERTISEMENT Don't want ads? Subscribe or login now. By Rob Church, Heidi Gertner and Blake Wilson (March 4, 2024, 2:29 PM EST) -- On Feb. 13, the U.S. Food and Drug Administration published a draft guidance on the use of data monitoring committees, or DMCs, in clinical trials, titled "Use of Data Monitoring Committees in Clinical Trials."...
-
Mar 4, 2024 | 
law360.co.uk | Rob Church |Heidi Forster Gertner |Blake Wilson
ADVERTISEMENT Don't want ads? Subscribe or login now. By Rob Church, Heidi Gertner and Blake Wilson (March 4, 2024, 2:29 PM EST) -- On Feb. 13, the U.S. Food and Drug Administration published a draft guidance on the use of data monitoring committees, or DMCs, in clinical trials, titled "Use of Data Monitoring Committees in Clinical Trials."...
-
Feb 21, 2024 | 
jdsupra.com | Stephanie Agu |Robert Church |Heidi Forster Gertner
FDA recently issued a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.”When finalized, this guidance will replace the 2006 final guidance on the same topic entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees.” A DMC[1] is a group of experts that reviews accumulating data from one or more ongoing clinical trials in order to monitor the continuing safety of trial...
-
Feb 21, 2024 | 
lexology.com | Robert Church |Heidi Forster Gertner |Blake Wilson |Stephanie Agu |Eva Schifini
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.” In the Federal Register notice announcing the draft guidance, FDA explained that there has been “an increase in the use of DMCs in many disease areas not involving serious morbidity or mortality.” Among other things, FDA noted that DMCs can provide specialized expertise to evaluate...
-
Feb 19, 2024 | 
jdsupra.com | Stephanie Agu |Heidi Forster Gertner |Blake Wilson
FDA originally published final guidance on the collection of race and ethnicity data in clinical trials in 2016, in response to the Office of Management and Budget (OMB) Statistical Policy Directive 15, Revisions to the Standards for the Classification of Federal data on Race and Ethnicity, which was developed to provide a common framework for uniformity and consistency in the collection and use of data on race and ethnicity by federal agencies.
-
Feb 17, 2024 | 
lexology.com | Stephanie Agu |Heidi Forster Gertner |Blake Wilson |Eriko S. Yoshimaru
The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity Data in Clinical Trials,” which provides recommendations on the standardized collection of race and ethnicity data.
