ICH guideline
ICH M11 EWG: Clinical electronic Structured Harmonised Protocol (CeSHarP)
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M11 EWG |
|---|---|
| Title | Clinical electronic Structured Harmonised Protocol (CeSHarP) |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Management Committee in November 2018. This new guideline is proposed to provide comprehensive clinical protocol organisation with standardised content, with: A Template which presents the format and structure of the protocol, including the table of contents, common headers, and… |
| File | WG Explainer on ICH M11 |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- WG Explainer on ICH M11 Files published by ICH
- None FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.