Good Clinical Practice: A Question & Answer Reference Guide - May 2017 - 106

GCP: A Question & Answer Reference Guide
3.17 Q. Since it is such common practice for companies to provide the 1572 and accompanying CV and other
information to the FDA in the original IND and subsequently when a new investigator is added to the
study, has that become an agency expectation or even a de facto requirement?
A. None of several Center for Drug Evaluation and Research review divisions contacted in past years claimed that
the submission of the 1572 was a divisional expectation. And most did not express even a preference in terms of
the format (i.e., a 1572 or alternative format) in which IND applicants should provide investigator qualificationrelated information.
It is important to note, however, that there have been differences in the preferences of some CDER review
divisions in the past, and that applicants should ask about a division's policy in this area. Under a 1992 policy,
for example, the Division of Oncologic Drug Products had asked that sponsors of commercial INDs (i.e., those
submitted by industry) not submit either the 1572 or the investigator's CV for new investigators because such
submissions were "inefficient and cumbersome." Rather, in its "no CV letter," the division had asked that all
IND holders submit summary information, including "the minimum qualifications of investigators selected for the
protocol... and a statement that each investigator meets or exceeds those qualifications."
3.18 Q. Suppose that a protocol amendment is made in a clinical study and, consequently, that there is a
protocol title change. Would this situation call for all investigators to complete and submit a revised 1572
that updates Section 7 (Name and code number, if any, of the protocol(s) in the IND for the study(ies) to
be conducted by the investigator) with the new protocol title?
A. In its May 2010 guidance titled, "Frequently Asked Questions-Statement of Investigator (Form FDA 1572),"
the FDA noted that investigators should provide in Section 7 "the name and code number (if any) of all the protocols
under the IND that will be conducted by the investigator signing the 1572. A code number is an identifying number
assigned by the sponsor."
In a informal response regarding updating this section when there is a change in the protocol's title, however, the
FDA's Good Clinical Practice Program acknowledged that, "this situation is not specifically addressed in FDA's
regulations, so there are any number of approaches that could be used to document the study file about the change
in the title of the study, if that is indeed all that has changed. Probably the most straightforward way to address this
would be for the investigator to fill out a new 1572 with the correct title on it. If nothing else, having the correct title
on the 1572 will ensure that the investigator and sponsor are in agreement about which protocol the investigator
is carrying out at the site. As you know, the sponsor is supposed to obtain a signed and completed 1572 before
permitting an investigator to begin participation in an investigation [see 21 CFR 312.53(c)]. A 1572 should be
completed for each study that an investigator is involved in-that is, the form is study specific. So, if an investigator
has completed a 1572 for protocol 'A', and then the same sponsor wants the investigator to also participate in
protocol 'B', the sponsor must obtain a new 1572 for protocol 'B.'
"The sponsor of a study should have appropriate procedures for identifying a protocol, for amending the protocol,
and for numbering subsequent versions to ensure that investigators involved in the study can readily identify the
most up-to-date version. The purpose of reporting the title of the protocol on the 1572 is to ensure that the study can
be correctly identified and that the sponsor and investigator know which protocol the investigator is going to follow.
The protocol title and version number would also be important to the IRB in identifying the study and ensuring
proper review and approval.
"While a title change for a protocol may not seem like a major change, it may raise other questions: Is this indeed
the same, or a different, study? Why was the name changed? Was it done to correct a typographical error, or for
some other reason? Did the dosage of the study drug change? Has there been a change in the study's design? Did
the site receive [and follow] the correct study protocol? (etc.)
"Any documentation about a change in title should address these questions (there may be others as well), but
in any case, it should be clear which study the investigator is carrying out, and in addition, whether that study has
been reviewed and approved by the IRB."
3.19 Q. We are now planning to conduct a "Treatment Protocol/Expanded Access" program for a drug
and indication on which we are already conducting a conventional clinical trial. If the same sites are
conducting the conventional and treatment/expanded access elements of the study, do we need to re106

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2017