M11 has now been adopted (released) by ICH and the final versions are available on the ICH website
A comparison of the template specification changes can be found within Template Specification Change Comparison. This is a document comparison performed on the MS Word versions of the template specification.
Significant Changes
The significant changes from the previously publicly available version (used to align M11 with USDM v4) are:
- Current Amendment (after the title page): Amendment Scope Enrollment Definition, there needs to be a check to see if there is any subtle change to how this is being handled. The CT has been amended to Global / Not Global.
- Current Amendment, Primary and Secondary reason for amendment, there is a difference in the CT between M11 and USDM. Alignment is needed. The Preferred Terms appear to be the same, but the C codes differ (new terms have been created)
- Section 1.1.2, Intervention Assignment Method, note the additional information regarding Randomisation and the new Stratification Indicator element
- Section 9.2, Timing and Procedures for Collection and Reporting: There is some CT for the Event Type. This may need support in USDM and should be looked at closely. There is a table which suggests structure. Currently this would be supported by NarrativeContent and NarrativeContentItem
- Section 12.3, Prior Protocol Amendments: Similar updates as per the enrollment in the current amendment section.
- Section 12.3, Prior Protocol Amendments: The Section code list has been shortened to just to the top level sections. This implications of this change need some consideration.
- Section 12.X, Section has been added to the template
CT
- There is now clarity on the M11 terminology and thus better mapping information between USDM and M11 can be provided. For example, M11 uses Yes/No text for Adaptive Trial Design Indicator but USDM stores such information as Characteristics (Adaptive Design present) from which the Yes/No status is derived)
- All CT should be closely checked to ensure alignment or ensure clarity on how users should align. For example Trial Phase, the M11 terms are a subset of the CDISC terms with additions. These changes may have an impact wider than just USDM (e.g. SDTM Trial Design Domains might need to change)
- See a provisional CT analysis for more details regarding the CT.
Minor Changes
Minor changes that should be checked for impact are:
- Title page, sponsor signatory and medical expert contact elements need checking to see if USDM still handles the M11 needs
Editorial Changes
In addition to the significant changes, there are many minor editorial changes. These should not impact the USDM but there is no harm in having a further check to ensure this assessment is correct.
M11 USDM Mapping
This should be improved now M11 and USDM are stable, with improved tool support for the creation and maintenance of the mappings.
M11 has now been adopted (released) by ICH and the final versions are available on the ICH website
A comparison of the template specification changes can be found within Template Specification Change Comparison. This is a document comparison performed on the MS Word versions of the template specification.
Significant Changes
The significant changes from the previously publicly available version (used to align M11 with USDM v4) are:
CT
Minor Changes
Minor changes that should be checked for impact are:
Editorial Changes
In addition to the significant changes, there are many minor editorial changes. These should not impact the USDM but there is no harm in having a further check to ensure this assessment is correct.
M11 USDM Mapping
This should be improved now M11 and USDM are stable, with improved tool support for the creation and maintenance of the mappings.