Integrated Research Application System (IRAS) Guidance and Wording GENERAL INFORMATION This guidance aims to provide additional information to enable you to negotiate your way through IRAS, find explanations of commonly misunderstood questions, and to provide the specific wording required when you would like the University to take on the role of Sponsor. We have structured this guidance under the main headings present in the on-line system. IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK and such acts as a repository for all the information required for the relevant approvals from the following bodies: Administration of Radioactive Substances Advisory Committee (ARSAC) Gene Therapy Advisory Committee (GTAC) Medicines and Healthcare products Regulatory Agency (MHRA) NHS / HSC R&D offices NRES/ NHS / HSC Research Ethics Committees Confidentiality Advisory Group (CAG), formerly the National Information Governance Board (NIGB) National Offender Management Service (NOMS) Social Care Research Ethics Committee In addition to the points in this document, on-line guidance is available in IRAS wherever you see a hyperlinked word or this symbol within the form Further help can be found at: https://www.myresearchproject.org.uk/Help/HelpPage.aspx INFORMATION ON SPECIFIC QUESTIONS FILTER QUESTIONS In its original state, the form is very long. However, as soon as you fill out the filter section on the left of the IRAS screen, it will be cut down considerably, to provide you with only those questions that are relevant to your study. It is important to select the correct answers for this section; otherwise, you will miss out important information required for your study. 2 List of categories For non-CTIMPs involving drugs, study’ is the most appropriate category since this enables ‘Other questions about the medication and safety issues. 4 Review bodies If your project is taking place in the NHS and is led from England select 'IRAS Form'. If your project is led from Northern Ireland, Scotland or Wales select 'NHS/HSC Research and Development Offices' and/or relevant Research Ethics Committee applications, as appropriate NHS organisations in England no longer use NHS SSIs. It is necessary to complete separate documents: A Statement of Activities and Schedule of Events. If your trial involves administration of radioactive substances and you require an ARSAC license, CTRG will advise on how to generate this.
Integrated Research Application System (IRAS) Guidance and Wording GENERAL INFORMATION This guidance aims to provide additional information to enable you to negotiate your way through IRAS, find explanations of commonly misunderstood questions, and to provide the specific wording required when you would like the University to take on the role of Sponsor. We have structured this guidance under the main headings present in the on-line system. IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK and such acts as a repository for all the information required for the relevant approvals from the following bodies: Administration of Radioactive Substances Advisory Committee (ARSAC) Gene Therapy Advisory Committee (GTAC) Medicines and Healthcare products Regulatory Agency (MHRA) NHS / HSC R&D offices NRES/ NHS / HSC Research Ethics Committees Confidentiality Advisory Group (CAG), formerly the National Information Governance Board (NIGB) National Offender Management Service (NOMS) Social Care Research Ethics Committee In addition to the points in this document, on-line guidance is available in IRAS wherever you see a hyperlinked word or this symbol within the form Further help can be found at: https://www.myresearchproject.org.uk/Help/HelpPage.aspx INFORMATION ON SPECIFIC QUESTIONS FILTER QUESTIONS In its original state, the form is very long. However, as soon as you fill out the filter section on the left of the IRAS screen, it will be cut down considerably, to provide you with only those questions that are relevant to your study. It is important to select the correct answers for this section; otherwise, you will miss out important information required for your study. 2 List of categories For non-CTIMPs involving drugs, ‘Other study’ is the most appropriate category since this enables questions about the medication and safety issues. 4 Review bodies If your project is taking place in the NHS and is led from England select 'IRAS Form'. If your project is led from Northern Ireland, Scotland or Wales select 'NHS/HSC Research and Development Offices' and/or relevant Research Ethics Committee applications, as appropriate NHS organisations in England no longer use NHS SSIs. It is necessary to complete separate documents: A Statement of Activities and Schedule of Events. If your involves administration of radioactive substances and you require an ARSAC license, CTRG will advise on how to generate this. trial
CTRG_form_306h_v3_IRAS_Guidance__14_Oct_2016.docx