Guidance on Administrative Modifications to TCC Documents Due to NHG Rebranding

Purely administrative changes to TCC documents (such as ICFs) arising from the rebranding exercise will not require TCC amendment submissions.

Guidance on Administrative Modifications to TCC Documents Due to NHG Rebranding

1. Changes Not Requiring TCC Amendment

No Amendment (AMD) submission to the TCC is required if changes are strictly limited to:

• Cluster logo and name updates (ex. NHG -> NHG Health)

• Website hyperlink modifications

• Contact email address revisions

• Other rebranding-related administrative changes in Informed Consent Form

2. Documentation Requirements

Tissue teams must maintain proper documentation by either:

a) Keeping a tracked changes version showing the modifications made, OR

b) Creating a file note in the Tissue file documenting all administrative revisions

3. Donor Notification

• Tissue teams have the discretion to determine if existing donors need to be informed of these administrative changes

• This decision should be based on the practical impact these changes may have on donor participation and communication

4. Notifying TCC at point of Yearly Renewal

• When submitting your Status Report Form, if the tissue team has updated ICFs that have new version numbers or dates due to NHG rebranding, please include this statement in Section 5(a):

  • "Changes to the ICF reflect NHG rebranding updates only. No content modifications were made."

• This clarification will help expedite review by confirming that ICF changes are administrative rather than substantive.

5. Important Notes

• This guidance applies only to purely administrative changes related to rebranding

• Any other modifications still require standard TCC amendment procedures