Study Documentation Tools

Study Documentation Tools

According to the International Conference on Harmonization Good Clinical Practice (ICH GCP), a key responsibility of an investigator is to maintain trial-related documents which permit evaluation of the conduct of a study and the quality of the data produced. These Essential Documents include participant documents, regulatory binder documents, and protocol-assessment related documents.

The customizable tools provided below are optional, but highly recommended to assist study teams in meeting protocol and regulatory standards.

Participant Files

These tools will help you manage participant documentation for your research study:

Regulatory Binder Files

These tools will help you manage regulatory documentation for your research study:

Self-Assessment Review Tools

These tools are easy-to-use checklists that will help you assess your study documentation and conduct in multiple areas, including protocol adherence, inclusion/exclusion adherence, and informed consent documentation: