Study Documentation Tools
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 trial-related documents which permit evaluation of the conduct of a trial and the quality of the data produced. These “Essential Documents,” include both participant-specific documents and regulatory and protocol-related documents, and are specified in ICH GCP Guideline section 8.0.
The customizable tools provided here are optional, but these (or similar) tools are highly recommended to assist study teams in meeting protocol and regulatory standards to ensure valid and reliable data.
|Participant Files||Research Subject Eligibility Assessment Form: Helps you document individual research subject eligibility assessments.|
|Templates that will help you manage participant documentation for your research study.||Documentation of Informed Consent Tool: Tool that will guide you through documenting the informed consent process.
Documentation of Pregnancy Testing: This tool will help you document pregnancy testing or the determination that pregnancy testing is not required.
|Self-Assessment Review Tools
Easy-to-use checklists can help you assess your study documentation and conduct in multiple areas: consenting, inclusion/exclusion criteria, and protocol adherence.