Yes. Per ICH GCP 8.3.21, you should keep a confidential list of all participants who are
enrolled on a trial that includes the names of the individuals linked to participant ID numbers.
This type of document should not be kept in the regulatory binder and should be separate from
participant-specific files but in another secure location, such as in a locked file in a locked
office.
Participant-specific source documents and Case Report Forms are typically kept in participant
files. Signed consent forms are typically kept in the participant files or in a separate location.
Financial documents should be stored separately.
Though not considered study documentation, staff should have easy access to references
such as regulations and guidelines guiding your research. These may include but are not
limited to: FDA regulations (21 CFR 312 for drugs and 21 CFR 812 for devices), applicable
FDA guidance, DHHS OHRP regulations (45 CFR 46, also known as “The Common Rule”),
ICH GCP guidelines, ethical guidelines such as the Nuremberg Code, the Declaration of
Helsinki, and the Belmont Report, and local (institutional) policies.
