Before you begin the consultation questions, please download and complete the MHRA spreadsheet for comments. You can use this to leave specific line by line comments on the guideline document. This is a required part of the consultation. The spreadsheet can also collect general comments by entering the line reference “0” as per the instructions in the spreadsheet if you have no specific comments to make on particular line numbers in the guideline document.
When completing the spreadsheet, we strongly encourage you to consider the following when drafting your comments:
- Prioritizing or highlighting key comments.
- Correlating your comment with the corresponding line number of the draft guideline to make it easier for us to identify relevant text.
- Providing justification and any relevant examples to support suggested changes.
- Consolidating comments from the same organisation, if appropriate.
We are requesting inputs across all topics addressed in this draft guideline, but please focus on key issues and consider providing insights on:
- Areas that may need additional clarity or language that may be susceptible to misunderstanding.
- Areas that may not accommodate technological innovations and design elements that are being explored to make clinical trials more efficient (we welcome examples to help inform us).
- Training components that should be included to make global MIDD training useful as the EWG is planning to develop training materials for ICH M15 MIDD guideline.
You will be able to re-upload the spreadsheet at the end of the survey.
Make sure to add your respondent ID to the spreadsheet: 03e65ff5-42da-4d21-a6a0-1c30e1f3d1d7
If you would like to leave this survey and return after adding comments to the spreadsheet please feel free to do so. You may wish to bookmark this page. To help with your preparations for this survey, you can find a list of questions covered in the survey here.
