About the HRA Schedule of Events and Statement of Activities templates for non-commercial studies
One aspect of HRA Approval is ensuring that there is clarity on the resource implications for participating NHS organisations and others delivering research within an NHS care setting. The documentation required for submission to the HRA enables participating NHS organisations In England to assess and confirm their capacity and capability to deliver the research.
For non-commercially sponsored studies the HRA is testing the use of Schedule of Events and Statement of Activities templates (see below) to capture all information around study activities being undertaken at a local level.
Non-commercial sponsors may propose to the HRA that the Statement of Activities is used with participating organisations as a form of site agreement, in line with the criteria and standards published by the HRA. Where the sponsor does not intend to use the Statement of Activities as the site agreement, or where the HRA indicates that this is appropriate, the template(s) of the agreement(s) that the sponsor does intend to use with participating organisations should be submitted to the HRA as part of the submission checklist from IRAS.
Commercially sponsored studies
For commercially sponsored studies Schedule of Events and Statement of Activities templates are not used. Instead, a completed NIHR Industry Costing Template (external link) should be submitted to the HRA, along with the template agreement(s) (external link) that the sponsor intends to use with host organisations. Where it is intended that the study will be part of the NIHR CRN portfolio, the costing template should be validated by the lead CRN for the study prior to submission to the HRA. We recommend early engagement with your lead CRN. Studies which will not be part of the NIHR portfolio still require submission of the NIHR costing template as part of the application to the HRA. In these circumstances the template will be validated by HRA staff.
Using the Statement of Activities template
We strongly recommend that you refer to both the general and question specific guidance in the templates. The HRA Schedule of Events guidance document should also help you to complete the document. Please note that all questions marked with a red asterisk indicate a sponsor/applicant field we expect you to complete before you submit the document to HRA. If, after referring to the guidance, you require any clarifications on the use and/or completion of these templates then you are strongly recommended to contact the HRA Approval Team.
If your study has more than one NHS research site and not all of these sites will be undertaking the same research activities (i.e. you have more than one ‘site-type’) then one Statement of Activities and one Schedule of Events should be submitted to HRA for each ‘site-type’, not for each site. In each document you should set out the research activities to be undertaken and the financial arrangements for the sites that it covers. Where multiple Statement of Activities and Schedule of Events documents are needed, we recommend that sponsors clearly set out in their application for HRA Approval which documents apply to which sites.
The completed Statement of Activities template(s) must be saved as a Word file and the completed Schedule of Events template(s) must be saved as an Excel file. All filenames should include the IRAS ID. The documents should be submitted with your application for HRA Approval. Please ensure that you are using the current version of the templates (as published on the HRA website) before completing them as the templates are updated from time to time following user feedback.
- Download the Statement of Activities Word template (dated 10 May 2016; doc)
- Guidance for use with Statement of Activities (dated 10 May 2016; pdf)
- Download the HRA Schedule of Events Excel template (dated 6 April 2016; xls)
- Access e-learning on attribution of costs for research in the NHS from the NIHR Clinical Research Network
Following your application for HRA Approval and when you have received the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter needs to be issued), you can supply the local document package to sites, including the local research team (where applicable), the research management function supporting them and the Local Clinical Research Network (LCRN) where relevant (contact details for research management offices and LCRNs are available from the NHS R&D Forum website). This local document package will include the Schedule of Events and Statement of Activity which have been assessed by the HRA. Please send only the Schedule of Events or Statement of Activity that describes the site type relevant to the activities intended to take place at individual organisations.
Before sending the Statement of Activities to the participating organisation, please complete the name of the organisation and any other local information you have discussed with the organisation. The participating NHS organisation will complete other sections. The sponsor and participating organisations should mutually agree the contents of the Statement of Activities so that all parties have clarity about the agreed activities at the site.
Providing feedback on the Statement of Activities
Both documents include the standard HRA form for obtaining user feedback. You may submit your feedback as part of the application for HRA Approval or separately via email to the HRA Approval Programme Team.
We are also keen to understand how the Statement and Schedule are used in setting up studies at host organisations and so we would appreciate feedback from sponsors and host organisations on this aspect of the process. Please send your comments via email to the HRA Approval Programme Team.
< HRA Approval: NHS organisation guidance; version 4.0, dated 4 February 2016 >