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Page 1 of 2 PSC Publishing Services 301 443-6740 EF 8. SIGNATURE OF INVESTIGATOR Sign WARNING A willfully false statement is a criminal offense. U.S.C. Title 18 Sec. 1001. Form Approved OMB No. 0910-0014 Expiration Date April 30 2015 See OMB Statement on Reverse. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION STATEMENT OF INVESTIGATOR TITLE 21 CODE OF FEDERAL REGULATIONS CFR PART 312 See instructions on reverse side. EDUCATION TRAINING AND EXPERIENCE THAT QUALIFY THE INVES ...

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How do I fill out a FDA 1572?

Field 1: NAME OF AND ADDRESS OF INVESTIGATOR. Field 2: EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFY THE INVESTIGATOR AS AN. EXPERT IN THE CLINCIAL INVESTIGATION OF THE DRUG FOR THE USE UNDER INVESTIGATION. Field 3: NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH.

Is a 1572 required for a device study?

Does the clinical investigator need to sign form FDA-1572? No, this is a form used for drug studies. For device studies, the sponsor should develop an investigators agreement which includes the elements of 21 CFR 812.43(c).

What goes on a 1572?

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

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.

Which of the following reports must be filled using a Form FDA 1572?

Which of the following reports must be filed using an Form FDA 1572? In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: Conduct or supervise the investigation personally.

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Which party submits the Form FDA 1572 to the FDA?

When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation.

What is a form 1572 per the FDA?

The Statement of Investigator (Form FDA 1572) is a form that is required to be filled for clinical trials involving investigational drugs or biologics.

Who completes Form FDA 1572?

Do all studies need a 1572?

Under FDA regulations, a 1572 is only required for studies of investigational drugs and biologics conducted under an IND. It is not required for studies that are not done under an IND and is not applicable to investigational device studies.

When should a 1572 be completed?

When Must the Form be Updated or a New One Completed? In cases when a new site is added or of replacement of an investigator at an existing site, a 1572 must be submitted to the FDA within a 30-day window of the site's/investigator's addition/replacement.