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Submissions

Submission guidance - all review bodies



Contents

  1. General guidance on making submissions using IRAS
  2. ARSAC applications
  3. Gene Therapy Advisory Committee applications
  4. HRA Approval applications
  5. MHRA Devices notifications
  6. MHRA Medicines - applications for clinical trial authorisation
  7. National Offender Management Service applications
  8. NHS R&D offices - main application form
  9. NHS R&D offices - Site Specific Information Form
  10. Confidentiality Advisory Group applications
  11. Research Ethics Committee - main application for ethical review
  12. Research Ethics Committee - application for Site-Specific Assessment at non-NHS site


General guidance on making submissions using IRAS


Applications with a Submission tab and "Proceed to Submission" button

Clicking on "Proceed to Submission" under the Submission tab will store the application in your Submission History in IRAS and generate a submission code, which will appear at the foot of each page of the form for reference. You will then be able to save and/or print the completed form for submission. Please follow the on-screen instructions.

NOTE: selecting "Proceed to Submission" does not actually submit your application to the reviewing organisation.

To submit the application, please follow the guidance under the Submission tab for the relevant type of form.

If you need to amend the application subsequently, selecting Proceed to Submission will save a new version and generate another submission code.

Applications with an E-submission tab and a button to electronically submit application

Some applications in IRAS are enabled for full electronic submission. In these cases the form will have an "E-submission" tab. Where a form is enabled for full electronic submission, selecting to submit the application by clicking on the "E-submit application" button (or button similarly labelled within the tab) will electronically submit the application form and the supporting documents that have been uploaded to the checklist. Please ensure that you read the guidance provided in the tabs prior to submitting the form.

Once you have electronically submitted your application, a record of that submission and any updates on progress that are notified by the review body to IRAS will be shown in the submission history area at the bottom of the E-submission tab.

To print an application form for review prior to submission, please use the Print option within the form or under the Save/Print tab.

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ARSAC applications


The application to the Administration of Radioactive Substances Advisory Committee (ARSAC)  is split into a project (“Preliminary Research Assessment (PRA)”) form and a shorter site specific (“Research Certificate Application (RCA)”) form.

The PRA and RCA forms are automatically generated whenever the project filter has been completed to indicate that the study involves exposure to radioactive substances. Both forms are automatically populated from data entered in the integrated dataset for other applications, particularly the NHS Research Ethics Committee (REC) form (or IRAS Form).

The PRA form should be submitted by the sponsor’s representative to the ARSAC Support Unit as soon as the application for ethical review has been submitted. The RCA form(s) may then be submitted by the local certificate holder(s).

Applications to ARSAC for individual research certificates at each site may not be submitted until the Preliminary Research Assessment form has been submitted. However, the first certificate application may be submitted alongside the Preliminary Research Assessment form.

For further guidance please contact the ARSAC Support Unit.

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Gene Therapy Advisory Committee applications


This application is enabled for full electronic submission. You should attach all supporting documents to the checklist associated with the form before you submit the application. This will mean that when you select to electronically submit the application, the form and associated supporting documents will be electronically transmitted from IRAS to GTAC. Please ensure that you follow the instructions provided on the E-submission tab.

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HRA Approval


This application is enabled for full electronic submission. You should attach all supporting documents to the checklist associated with the form before you submit the application. This will mean that when you select to electronically submit the application, the form and associated supporting documents will be electronically transmitted from IRAS to the HRA. Please ensure that you follow the instructions provided on the E-submission tab.

Additional guidance is available in the IRAS Help section for HRA Approval.

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MHRA Devices notifications


For all notifications, please send the signed copy of PCA1, together with PCA2 and the sterilisation annex (where applicable) and eight copies of all supporting documentation by post to MHRA Devices Division.

The postal address for submissions is given at the foot of the following page on the MHRA website:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=194

Before submission, please ensure that PCA1 is signed by the manufacturer's authorised signatory.

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MHRA Medicines - applications for clinical trial authorisation


You must submit your application by sending the following to the Clinical Trials Unit at MHRA:
  • Covering letter
  • EudraCT application form (as XML and PDF files)
  • Protocol
  • Investigational Medicinal Product Dossier or SmPC where relevant
  • Specified particulars and documents (supporting data)
  • Applicable fee.
For detailed guidance on submission procedures and preparation of documentation, please see the MHRA website:

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Applyingforaclinicaltrialauthorisation/index.htm

For information on importing and export between IRAS and the EudraCT application form, please go to the import/export tab.

It is no longer necessary to enclose a copy of the EudraCT application form with REC and NHS R&D applications completed in IRAS, as the information needed for review is included in the IRAS dataset.

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National Offender Management Service (NOMS) applications


The completed application should be saved in IRAS as an XML and PDF file. Both files must be submitted as email attachments to the NOMS National Research Coordinator. Please send the application to national.research@noms.gsi.gov.uk

Please also include the following documentation on letterhead when sending the application form:
  • CV for Researcher and all other Researchers
  • Questionnaire for participants (if applicable)
  • Information/Consent form for participants
  • Ethics approval form/an ethics assessment from an appropriate body/covering letter from sponsor if appropriate
Hard copy is not required.

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NHS R&D offices - main application form


Please refer to the IRAS Help page for NHS/HSC R&D Permissions for guidance. 

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NHS/HSC R&D offices - Site Specific Information (SSI) Form
 

NHS/HSC Site Specific Information Forms – these are used as part of the permission process for research involving the NHS/HSC in Scotland, Wales and Northern Ireland. These should be prepared and submitted in accordance with national arrangements. Research involving the NHS in England is managed through HRA Approval.


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Confidentiality Advisory Group (CAG) applications


Further guidance for applying to CAG can be obtained from the Health Research Authority (HRA) website.

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Research Ethics Committee - main application for ethical review


[The same guidance applies whether the application relates to a specific research project, a research tissue bank or a research database.]

This application is enabled for full electronic submission. You should attach all supporting documents to the checklist associated with the form before you submit the application. This will mean that when you select to electronically submit the application, the form and associated supporting documents will be electronically transmitted from IRAS to the REC. Please ensure that you follow the instructions provided on the E-submission tab. 

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Research Ethics Committee - application for Site-Specific Assessment at non-NHS site


This application is enabled for full electronic submission. You should attach all supporting documents to the checklist associated with the form before you submit the application. This will mean that when you select to electronically submit the application, the form and associated supporting documents will be electronically transmitted from IRAS to the REC.

The Principal Investigator should electronically submit the non-NHS Site Specific Information (SSI) Form to the Research Ethics Committee (REC) responsible for SSA, with accompanying documents as set out in the submission checklist.

Please ensure that you follow the instructions provided on the E-submission tab. 

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IRAS Integrated Research Application System, version 5.9.1, 23/07/2018, IRAS Dataset version 3.5.
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