Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 61

Investigators/Sites - Statement of Investigator Included (Global)
2.73 Q. Many heralded the FDA's statement that " the research coordinator should usually be listed in Section
#6 of the 1572 " as a change or shift in agency policy. Was it?
A. No. In reality, it represented more of an FDA acknowledgment that most research coordinators undertake studyrelated
tasks and have study-related responsibilities that would call for them to be listed in Section #6. At the same
time, this may represent the first time that the agency has so clearly acknowledged this reality.
It did not represent, as some observers seemed to infer, a new or newly expressed FDA position that all research
coordinators should be listed in Section #6. In fact, the above-cited passage seems to re-affirm the agency's oftenstated
standard that only those individuals who " perform critical study functions and make direct and significant
contributions to the data " should be listed.
In other recent comments, in fact, FDA officials have encouraged the use of an individual's job description rather
than his/her job title in determining whether they should be listed on the 1572.
2.74 Q. Since they appear to be such key concepts in determining whether an individual should be listed
as a subinvestigators on the 1572, has the FDA provided any additional insights into what qualifies
as " significant study-related duties, " " performing critical study functions, " or making " a direct and
significant contribution to the data " ?
A. Not directly, although a growing number of warning letters are providing insights on the agency's views in this
area. Based on a review of warning letters, administering the informed consent form, determining subject eligibility
for the trial, and dispensing study drugs are among study activities that the agency considers " significant " for the
purposes of identifying the individuals who should be listed as subinvestigators.
There are also growing numbers of FDA formal and informal statements and FDA guidance documents that can
be used to interpret what is meant by such phrases. The examples below are captured some FDA responses, the
agency's May 2010 guidance titled, " Frequently Asked Questions-Statement of Investigator (Form FDA 1572), "
and other sources:
* In a November 2007 response to a closely related question, the FDA responded that the clinical investigator
should consider an individual's role in determining whether he/she should be. One of the main purposes of
the 1572 is to provide the sponsor with information about the clinical site(s) where the research will take
place, the investigator's qualifications, and information about other facilities that will be performing protocol
required tests. Providing this information to the sponsor allows the sponsor to establish and document that the
investigator and site are qualified to conduct the study.
* " If a research coordinator is performing critical study functions and making direct and significant contributions
to the data, then the coordinator should be listed in Section #6, " the FDA stated in its May 2010 guidance.
Unlike the draft version of the guidance, the final guidance provided a few examples of such functions and
contributions, including " recruiting subjects, collecting and evaluating study data, and maintaining study
records. " In the July 2008 draft version of the guidance, the FDA had stated that, " if the research coordinator
is only transcribing data and maintaining study files, the coordinator does not need to be listed " (this statement
not included in final version of guidance, however).
* " The decision to list an individual in Section #6 depends on his/her level of responsibility (i.e., whether he/
she is performing significant clinical investigation-related duties), " the FDA states in the May 2010 guidance.
" In general, if an individual is directly involved in the performance of procedures required by the protocol,
and the collection of data, that person should be listed on the 1572. For example, if the protocol notes that
each subject needs to visit a specified internist [who is not the clinical investigator but] who will perform a
full physical to qualify subjects for the study, that internist should be listed in Block #6. "
* " It is not necessary to include [in Block 6] a person with only an occasional role in the conduct of the research,
e.g., an on-call physician who temporarily dealt with a possible adverse effect or a temporary substitute for
any research staff, " the FDA stated in its May 2010 guidance.
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