Clinical research is expected to be conducted to the highest ethical and clinical standards.
Your documentation provides validation that the study is being conducted to these standards.
As above, a physical “binder” containing regulatory information is not required. The
documentation demonstrating appropriate study conduct IS required for any study, though
there may be additional requirements that are specific to studies conducted under FDA
regulations. For example, IND Safety Reports only pertain to those studies conducted under
an FDA IND.
That said, industry or government sponsors of clinical studies may have their own
requirements that regulatory information maintained by the site be maintained in specific ways.
Many sponsors supply sites with binders and organization strategies and these binders should
be used and sponsor instructions regarding organization of such files should be followed.
Documentation requirements in clinical research are specified in regulations such as DHHS
OHRP, FDA and guidance documents such as ICH Good Clinical Practice Guidelines (GCP)
and the tabs provided here have drawn directly from these references. Even if your study is
not conducted under an IND or IDE, the standards for study conduct and documentation
provided in these references are very useful.
If your study is not a drug or device study, it will still be useful to pick and choose those
components of the regulatory files that do pertain to your study. Much of the documentation
specifically required by FDA and/or ICH GCP guidance is common to studies that are not
regulated by the FDA (such as informed consent versions; CRF versions; protocol versions;
study staff logs; enrollment logs, etc.).
Regarding GCP guidance: This guidance was developed by an expert working group of the
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). It was published in the US Federal Register in May
1997, and, per FDA, “represents the FDA’s current thinking on conduct of clinical research.”
There is a reason this is called “Good Clinical Practice”… it is an international standard for the
conduct of clinical research. Compliance with ICH GCP helps ensure compliance with OHRP
and FDA regulations and also ethical standards guiding clinical research.
