Yes, you should maintain these outdated materials; they are a documentation of how the study
was conducted at a certain point in time. However, you may decide to file certain outdated
documents outside of the main regulatory “binder.” For example, if your study is in INSPIR,
you may decide only to keep the hard copy of the current INSPIR protocol because the
outdated ones are archived and accessible in INSPIR. (Be sure this process is acceptable to
the study sponsor.) If you keep any materials outside of the binder, it is helpful to document
where they are and how they can be accessed. You can use the Essential Documents
Location Log to do this. Likewise, some information, such as investigator/staff CVs and clinical
license information may be maintained centrally, especially in centers that have multiple
studies and staff working on more than one study (as above, be sure this process is
acceptable to the sponsor).
