Maintaining and storing the essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study. Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.