INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE:
CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL.

The clinical protocol describes the processes and procedures directing the conduct and analysis of 3 a clinical trial of medicinal product(s) in humans. To date, no internationally adopted harmonised 4 standard has been established for the format and content of the clinical protocol to support 5 consistency across sponsors and for the electronic exchange of protocol information.

Other fda guidances :

M11 Template: Clinical Electronic Structured Harmonised Protocol: https://lnkd.in/d9pDd2Dm

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol: https://lnkd.in/dq86pXUM

M11 Clinical Electronic Structured Harmonised Protocol:https://lnkd.in/d4WBMkxR