NCCAM Clinical Research Toolbox
Essential Study Documents (Regulatory Binder)
Several essential documents must be organized and retained for clinical studies. These organized documents are referred to as the Regulatory Binder (or Investigator Binder), which is retained at the Investigator’s Clinical site.
- Regulatory Binder Checklist [32KB Word file]
- Regulatory Binder Elements—Summary Sheet [1MB Word file]
- Protocol Amendment Summary of Changes Template [30KB Word file]
- FDA Document History Log [24KB Word file]
- Clinical Research Operations and Management Support Pre-Visit Site Assessment Questionnaire [86KB Word file]
- Study Product Guidelines and Considerations [37KB Word file]
- Delegation of Authority Log [37KB Word file]
- Guidelines for Writing Notes to the Study File [29KB Word file]
- Version Control Guidelines [72KB Word file]
* Microsoft Word documents can be read by downloading the free Word Viewer application.