Effective September 23, 2008, IntegReview is no longer requiring the submission of the Form FDA 1572 and our forms have been revised to remove this requirement. This form is only required to be submitted to the sponsor. As per the May 2010 Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions – Statement of Investigator (Form FDA 1572), this form is to provide the sponsor with information about the investigator’s qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation.
In cases where the Form FDA 1572 is submitted to IntegReview, our process is described below:
(1) When the Form FDA 1572 is submitted along with IntegReview’s New Study Submission Form or Investigational Site Revision Request Form (which incorporates requests for IC revisions), the requests will receive IRB review/approval; however, the Form FDA 1572 itself will not be reviewed.
(2) When the Form FDA 1572 is submitted by itself, only to request a revision to the form, it will not receive IRB review and the site will receive a Memo from IntegReview indicating this process.
For Form FDA 1572 please click here.
