Instructions For Filling Out Form Fda 1572 - Statement Of Investigator printable pdf download

I NSTRUCTIONS FOR FILLING OUT FORM FDA 1572 –

STATEMENT OF INVESTIGATOR

(The field numbers below correspond to the numbered boxes on the Form FDA 1572)

Field 1: NAME OF AND ADDRESS OF INVESTIGATOR

Provide the clinical investigator’s full legal name (e.g., name on the investigator’s birth certificate or marriage

certificate). Titles, degrees, and/or professional qualifications may follow the investigator’s legal name, if

desired. The address is where the investigator can be reached by mail or in person. Usually this corresponds

to the investigator’s work or business address.

Field 1 should only list one clinical investigator. The term co-investigator is not defined in FDA regulations.

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.

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

The investigator is required to attach either a Curriculum Vitae (CV) or “Other Statement of Qualifications”

showing the education, training and experience that qualifies the investigator as an expert in the clinical

investigation of the drug/biologic for the use under investigation.

Field 3: NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH

FACILITY WHERE THE CLINCIAL INVESTIGATION(S) WILL BE CONDUCTED

Provide the address(es) of the location(s) where the investigation will be conducted and clinical data will be

generated or collected and to where the test articles will be shipped.

Field 3 is intended to identify facilities where study activities will be conducted and clinical data will be

generated or collected. This includes facilities where subjects will be seen and study procedures will be

performed, e.g., locations such as health care facilities where the test articles will be administered, or

where physical exams will be performed. Facilities where other important clinical investigation functions are

performed may also be identified. For example, a research laboratory where the test article is prepared, a

special storage facility where the test article will be kept, or a location where tissue specimens are collected

should be in this section.

If an investigator sees study subjects at more than one site, the name and address of each of the study

sites should be identified in Field 3. However, if the protocol specifies that the investigative product can be

administered at a subject’s home (for example, the protocol allows for daily injections to be administered by

a registered nurse in the subject’s home), the subjects’ home addresses do not have to be listed on the Form

FDA 1572. Study records should reflect that the test article was administered at subjects’ homes per the

protocol.

Use the Continuation Page if additional space is needed.

Field 4: NAME AND ADDRESS OF ANY CLINICAL LABORATORY FACILITIES TO BE USED IN THE

STUDY

Identify clinical laboratories or testing facilities directly contributing to or supporting the clinical study (for

example, diagnostic labs performing blood work, imaging centers, cardiology labs, etc.). This may include

analytical labs that provide pharmacokinetic analysis, and laboratories supplying efficacy data for clinical

investigations conducted under an Investigational New Drug Application (IND).

FORM FDA 1572 SUPPLEMENT (7/13) – FORM INSTRUCTIONS

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Instructions For Filling Out Form Fda 1572 - Statement Of Investigator