Regulatory Tools and Resources

Study Documentation: Regulatory Binders

As per the International Conference on Harmonization Good Clinical Practice (ICH GCP) Guideline 4.9.4, a key responsibility of an investigator is to maintain certain trial-related documents so that it is possible to evaluate the ethical and procedural conduct of a trial and the quality of the data produced. These “Essential Documents,” including both participant-specific documents (such as completed Case Report Forms, source documentation and sighed consent forms) and study-related documents (such as the approved protocol and amendments) are specified in section 8 of the ICH GCP Guideline. We are pleased to provide you with materials that will help you manage regulatory documentation for your clinical research study. These materials include:

  1. Regulatory binder divider tabs that contain important information to help you with study documentation
  2. Optional customizable templates of logs used for regulatory record-keeping

Access the Regulatory Binder materials

Self-Assessment Review Tools

Establishing a process for ongoing self-assessments can help your study be “audit-ready” as well as ensure that your study meets the standards for conduct set by the institution, sponsor, and federal regulations. These easy-to-use checklists can help you assess your study conduct in multiple areas: inclusion/exclusion, consenting documentation and process, and protocol adherence. Note that instructions for using each of the assessment tools is included with each tool.

Access the Self-Assessment Review Tools