September 26, 2008

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

RE: Draft Guidance on FAQ- Statement of Investigator (Form FDA 1572)

Dear Reviewer:

The Association of Clinical Research Professionals (ACRP) has over
20,000 members of clinical research teams across the country and
additional members outside of the United States. On behalf of our
constituents, we extend our appreciation to the FDA for allowing us to
comment. We are very pleased with the FDA's offering guidance in this
area as the completion of the 1572 is an integral part of the daily
lives of our constituents. Particularly, we applaud the guidance offered
on Block #6 as this block is where we see the most inconsistencies and
the most chatter and debate on our forums regarding this form.

While we agree with the majority of the draft guidance, we wish to
identify a few areas that our constituents feel are not yet addressed or
areas where they have further questions based on the draft text
provided.

**Item #5: What are the minimum qualifications of an investigator?**

The requirements state that the sponsors should base their decisions on
the "general recognition that this would include familiarity with human
subject protection (HSP) requirements and practices as well as good
clinical practice (GCP) standards for the conduct of clinical studies".
We believe mentioning a concrete example such as achievement of
physician investigator certification (CPI) through a recognized entity,
such as the Academy of Pharmaceutical Physicians and Investigators
(APPI), would help provide an example of "generally recognized". In
fact, the US Department of Veterans Affairs recently approved ACRP and
APPI credentials for its list of "approved certifications."

**Item #17: How should an investigator's name appear on the 1572?**

The guidance mentions the use of the legal name on Block #1. Some
believe that the name must match exactly how their name appears on their
medical license (i.e. "James A. Smith, M.D." versus "James Smith,
M.D."). Is this the case?

**Item #30: Who should be listed as a subinvestigator in Block #6?**

The draft guidance makes reference in two parts to those who "make a
direct and significant contribution to the data" (lines 318-310,
330-332). The text further clarifies

what that may mean by giving good examples in section 31 and 32. The
sentence on lines 321-323, however ("In general, if an individual is
directly involved in the treatment or evaluation of research subjects,
that person should be listed on the 1572") seems to be inconsistent with
the clarity of "direct and significant contribution to the data" as it
implies that many of these persons (e.g. hospital nurse passing study
drug, the radiology technician) would need to be on the 1572 as they are
involved in the treatment of the individual. We believe deleting this
sentence would greatly bring internal consistency to the guidance and
thus decrease the existing confusion.

**Item #31: Should research nurses, other nurses, residents, fellows,
office staff, or other hospital staff be listed in Block #6?**

Lines 337-338 state that if there are staff residents on rotation, a
general statement can be made regarding their planned participation. We
would appreciate an example from the FDA on what kind of statement this
should be. Would a simple statement such as "Our hospital has residents
that rotate call and may be called in to perform physical evaluations or
handle adverse events on an as-needed basis" suffice?

Additionally, many settings such as psychiatric hospitals or specialty
clinics, contract with physician groups to perform physical exams and
care which may be used as data for the study. Under these arrangements,
it is not easily predictable as to which physician in the group will
show up that day to perform the care. This results in adding the entire
group to the 1572 and gathering all of their financial disclosures for
fear that one may show up that was not listed. Would this kind of
arrangement be equivalent to the resident example on lines 337-338 so
that the site can state a summary of how a group is contracted to
perform a certain duty?

Finally, in the event the general statements are not required to name
the subinvestigators by name, are they alleviated from the financial
disclosure requirements of 21CFR54, even if they perform study related
procedures that contribute to research data?

As always, we thank you for your review of our comments and request for
further clarification. Please do not hesitate to contact us in the event
we can further clarify or discuss our concerns.

Sincerely,

![](media/image1.png){width="2.1868055555555554in"
height="0.7430555555555556in"}

Thomas L. Adams, CAE

President & Chief Executive Officer