CORE Reference Project Team Compare TransCelerate CPT (v009) and Draft ICH M11 Step 2 Templates: A Comparison of Level 2 Headings

To download a copy of the text below and the CORE Reference Project Team's comparison table, please click here. 

An Open Access Resource Published on 13 December 2022

To date, no internationally adopted harmonised standard has been established for the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information. On 26 October 2022, ICH released a Step 2 draft guideline (M11) and harmonised template together with template specifications for public consultation. The scope of ICH M11 is to establish common instructions for protocol content and information. According to ICH “The guideline aims to have clinical trial protocol templates that are complete, free from ambiguity, well organised, and aligned with quality by design principles as set forth in other ICH guidelines.” The template has a core set of information for clinical trials including fonts that should be used in the protocols, numbering for tables and figures, as well as acceptable abbreviations. The public consultation period is due to end 26 February 2023.

ICH states that the draft M11 template has:

• Synopsis, Schema, Schedule of Activities near the front.
• Use of Main Body/Appendix framework, in which trial-specific information is in the Main Body, while reference details and more general (non-trial specific) information is in the Appendix.
• Unnecessary repetition eliminated wherever possible.

The TransCelerate Common Protocol Template (CPT) core structure has been aligned with the US National Institutes of Health and Food and Drug Administration Clinical Trials Protocol Template since 2017 and is widely adopted with updates to the template released as necessary. The CPT Level 1 and 2 headings are always included in the document and if not relevant for a clinical trial ‘Not Applicable’ is to be inserted, thus maintaining the numbering of sections. The most current version is ‘Clinical Template Suite (CTS) Release Addendum’. This is a track changes CPT (v009) with limited updates on the previous version. The Addendum explains that the next round of templates will be released after Q2 of 2023 in order to allow alignment with ICH M11 and EU Patient Centric Clinical Trial Platforms (EU‑PEARL).

The CORE Reference Project Team has conducted an initial comparison of Level 1 and Level 2 headings in the TransCelerate CPT Addendum (v009; file dated 12 October 2022) versus the Draft ICH M11 template. This comparison shows minimal differences between the two templates in the structure of the main body sections. Of note, some specific information presented under a Level 3 heading in the TransCelerate template is presented under a Level 2 heading in Draft ICH M11 template (e.g., Pregnancy). In addition, differences exist in the presentation of data from Section 10 onwards.

Although there is little difference in the Level 2 headings for protocol information required to be presented in the two templates, it should be noted that there is the potential for further changes depending on feedback garnered from stakeholders during the public consultation period (up to 26 February 2023).

Click TransCelerate CPT (v009, file dated 12 October 2022) Versus Draft ICH M11 Template: A Comparison of Level 2 Headings to view the text above and the table of comparisons.

CORE Reference Project Team