The term “Regulatory binder” refers to the place (and it’s not necessarily one place or even a
“binder”!) where regulatory documentation related to your study is stored and updated.
Just as your data validates and or invalidates your study hypothesis, your documentation
validates or invalidates your data. Your regulatory documentation tells part of the story that
validates your data. From this documentation, one can assess many aspects of investigator
and sponsor responsibilities (see Table 1) and the conduct of the study, including the non-bias
of the investigators, training and qualifications of study staff, appropriate recruitment and
enrollment of study participants, adequate accountability of the test article, adequate oversight
by PI, etc. A well-known saying regarding clinical documentation is: “If it’s not documented, it
didn’t happen.” This extends to clinical research documentation, with an important addition:
“AND the resulting data cannot be validated.” Data that cannot be validated cannot be used to
answer the study question. The only way for an outside person (such as a sponsor monitor,
auditor, or FDA inspector) to assess the quality of your study and its results is through your
documentation.
A complete regulatory binder provides documentation to support that the investigator adhered
to his or her responsibilities under federal laws and guidance for conduct of human subjects
research. Table 1 lists investigator and sponsor responsibilities along with the suggested tabs
in the binder where documentation supporting the fulfillment of these responsibilities is located.
The tabs and templates are provided here to help you in organizing your regulatory files to
ensure that your documentation tells the story of your study (that it happened according to the
approved protocol and the resulting data can be validated).
