PDF 508 versions of non-compliant Word documents can be found here Easy-to-use checklists can help you evaluate your study documentation and behavior in several areas: consent, inclusion/exclusion criteria, and protocol registration. Contains instructions for organizing essential documents for clinical research into a regulatory binder. This is stored at the clinical site or in the office of the medical examiner. Samples of documents to be deposited in the investigation binder are included. The NCCIH Clinical Research Toolbox provides a web-based information repository for auditors and staff involved in NCCIH-funded clinical research. The toolkit contains templates, model forms and information materials to help clinicians develop and conduct high-quality clinical studies.