Implementation of the UK Local Information Pack is confirmed for the 5 June 2019. It will be important to remember that from this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland. From this date the Statement of Activities and Site Specific Information form will no longer be in use.
The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.
Guidance and information is provided in IRAS Help and some explanatory questions and answers are available on the Four Nations Compatibility project web page.
Following feedback we have clarified the use and inclusion of the delegation log. Delegation Logs are required for all interventional studies requiring a local Principal Investigator. Sponsor will need to indicate if this is being provided with the UK Local Information Pack or if this is being provided at a later date i.e following Site Initial Visit. The Q&As have been updated with regard to this.
Further webinars will be held on 30 May at the following times 9.15, 11.00, 13.00 and 14.30. To register sign up here.
Update for Commercial Sponsors and Contract Research Organisations (CRO) (April 2019)
Setting up NHS / Health and Social Care Research in the UK (April 2019)
Setting up NHS / HSC in the UK (March 2019)
Implementing a UK Local Information Pack (February 2019)