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

Informational Brochures for Research Subjects or Prospective Subjects

The Boston University Clinical and Translational Science Institute (BU CTSI) participates in the New England Research Subject Advocacy group (NE RSA) to support the research community and participants with important resources such as informational brochures. The NE RSA is a collaborative effort among Boston University, Harvard Catalyst, Tufts University and The University of Massachusetts Medical School. The NE RSA has developed brochures to help researchers communicate and discuss, in plain language, some of the risks and benefits of certain studies or procedures, as well as participant rights and protections. These resources are also intended to provide research subjects or prospective subjects with helpful questions to think about and to ask before deciding to participate in a research study.

Access the Informational Brochures

Research Subject Eligibility Assessment Form

This template helps you track and document individual research subject eligibility/inclusion and exclusion criteria assessments.  The template is fully customizable.  To read more about why the form was created and when it should be used, please read the October 2014 CR Times column, The CRRO Corner

Access The Research Subject Eligibility Assessment Form