What is a Form FDA 1572?
A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.
Who should be concerned by FDA Form 1572 and why?
Under the US regulations, all US clinical trial sites must be subject to the US IND and all US clinical trial investigators must sign Form 1572. All study sites (foreign or US) that are listed on the IND must comply with all applicable US regulations and the Principle Investigator (foreign or US) must sign Form 1572.
What reports must be filed using a form FDA 1572?
The Statement of Investigator (Form FDA 1572) is a form that is required to be filled for clinical trials involving investigational drugs or biologics.
How often does a 1572 need to be updated?
The sponsor must update the IND accordingly. However, the 1572 does not need to be edited and a new one is not required. The sponsor can collect certain information and implement them to the IND.
Can study coordinators be on the 1572?
The FAQ states that study coordinators should”usually be listed in Section #6 of the 1572.” This is a significant change from the July 2008 draft FAQ. Many sites do not list studycoordinators on the FDA 1572, which means that most coordinators will need to file financial disclosure information.
Does FDA Form 1572 expire?
Despite the fact the form carries an expiration date, there is no need to provide a new form after the new version with the latest expiration date has been released.
Can you use an expired 1572?
Investigator (Form FDA 1572) May 2010”. expired version is the only one available on the website, it is acceptable to use the expired form.
Can an investigator have more than one form FDA 1572?
As commonly used, the term is meant to indicate that each co-investigator is fully responsible for fulfilling all of the obligations of an investigator as identified in 21 CFR 312.60. Thus under 21 CFR 312.3(b), each co- investigator is an investigator, and as such must sign a separate Form FDA 1572.
Is the study coordinator required to be listed on the 1572?