1. IRAS: Workshop Mike Morgan, R&D Governance Officer

2. Objectives Understand how to access and navigate IRAS (Integrated Research Application System.) Be aware of the range of application forms within IRAS and how they are generated. Understand how to manage and submit the various application forms

3. Introduction to IRAS IRAS stands for Integrated Research Application System Launched 29 th January 2008 A single system for applying for the permissions and approvals for health and social care/ community care research in the UK

4. Introduction to IRAS IRAS is NOT a form, it helps you produce your forms IRAS is not a new approval, it helps you to apply for approvals IRAS is not just for ethics, it produces all the application forms you need

5. Regulatory Bodies that use IRAS Administration of Radioactive Substances Advisory Committee (ARSAC) Gene Therapy Advisory Committee (GTAC) Medicines and Healthcare products Regulatory Agency (MHRA) Ministry of Justice National Offender Management Services (NOMS) NHS/ HSC research offices NRES/ NHS/ HSC Research Ethics Committees National Goverance Information Board (NGIB)

6. Advantages of IRAS Enter the information about your project once, on one site, instead of duplicating information in separate application forms on multiple sites. IRAS uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently, the permissions and approvals required. Helps you meet regulatory and governance requirements. Retains familiar aspects of the old NRES online application system.

7. Accessing the IRAS Website

8. Accessing IRAS Go to www.myresearchproject.org.ukwww.myresearchproject.org.uk If you already have an account for the NRES online form website, you can use the same login details to access IRAS. If not click the CREATE-ACCOUNT option on the IRAS main menu.

9. Creating an Account

11. Fill in the required fields (make sure the email you use is valid), tick that you accept the terms of the privacy policy and press the register button

12. You will now receive an email containing an activation code and a link which you should click on to activate your account. If for any reason you do not receive the automatic email, please call the helpdesk on 0207 099 2015 they will be able to assist you in completing the registration process. Accessing IRAS

13. Logging in

14. Enter your email address and password and press the submit button to login. Be aware that your username and password are case sensitive. Logging in

15. Task: If you have not already done so please can you log into IRAS

16. Creating a New Project

17. Click here to begin a new project Click here to return to this page Creating a New Project My Projects Page

18. Task: Please click the new project button

19. Project Filter Page

20. Clicking the ‘New Project’ button will take you to the ‘Project Filter’ page. This page is critical to each project. This is the page that defines exactly which forms will be made available to your project. As you go through the page, the questions may change depending on the answers to previous questions on the page. It is extremely important that you answer the questions on this page correctly; however, if you are unsure of an answer you can always come back to continue the answers. Creating a New Project Project Filter Page

21. Complete these questions correctly. If you don’t know an answer you can always come back. These Green icons when clicked will give you more information on the question. Creating a New Project Project Filter Page

22. Once you are happy that you have answered all the questions correctly click the ‘Save Now’ button. To continue after saving your answers click the ‘Navigate’ button Project Filter Page Creating a New Project

23. Please complete task 1

24. Navigation Page

25. The Navigation page is the main way of accessing your data and forms for a particular project. It can be accessed by clicking on any project listed on the My projects page, or when you are in any form or Project Filter – by clicking on the ‘Navigate’ button. Creating a New Project Navigation Page

26. Creating a New Project Navigation Page

27. Creating a New Project Navigation Page This section tells you the name of your project, the type of study and which form you are currently filling in

28. Creating a New Project Navigation Page If you click here you can return to the ‘Project Filter’ page. This will allow you to answer any questions you might have been unable to answer or to edit your answers.

29. Creating a New Project Navigation Page Clicking here will display all the questions you need to answer for every form. If you now complete the below form sections you will have answered all the questions on all the required forms (except the SSI)

30. Creating a New Project Navigation Page Links to the forms that you will need to complete for this research project. (These forms shown here are based upon the answers you gave in the ‘Project filter’ section.)

31. Creating a New Project Navigation Page Links to any site specific forms that are required for your project. An R&D application may consist of one main R&D form and a number of related site specific information forms (SSI). These forms will appear in this section.

32. Creating a New Project Navigation Page: Navigation Tab Navigate tab: This tab is available on all forms. It shows you which questions are active and which are not. Inactive questions are shaded blue and cannot be clicked on. Active questions have a white background and clicking on them will take you directly to those questions in the form. Questions are activated and deactivated depending on your answers to questions in both the project filter and the form itself. You can click the arrows left or right to see more tab options

33. Creating a New Project Navigation Page Inactive Section: You don’t need to be complete this section. Active Section: These sections of the form need to be completed. clicking on any of these boxes then you can begin filling in your form.

34. Filling in a Form Please click the box called “Proj Title-A1”

35. Creating a New Project Having clicked a box you are taken to that section where you can fill in the required questions.

36. Creating a New Project This section tells you which forms will automatically be populated with the information you added.

37. Creating a New Project You can click this icon to spell check your text You can click this icon to insert a symbol

38. Creating a New Project Quick Run through of the Tabs - Navigation Page This button will undo all the information you have typed in this section since your last save.

39. Creating a New Project Once you are happy that you have completed a section you can click on this icon to mark the information as completed. Once you have completed this section click either the ‘Navigate’ button to return to the Navigation page or press the ‘Next’ button to continue to the next set of questions. When you press any of these buttons your form will automatically be saved.

40. Please complete Task 2

41. Back to the Navigation Page

42. Creating a New Project Having clicked the ‘Navigate button’ you are returned to the ‘Navigation Page’ You will note that some of the boxes are now highlighted in green. This is because we clicked the tick icon on the previous page after completing that section. This will help you know which sections of your form are completed.

43. Run Through Of The Tabs On The Navigation Page

44. Adding an SSI Form

45. Add SSI Tab Quick Run through of the Tabs - Navigation Page: Add SSI Tab

46. Add SSI Tab Quick Run through of the Tabs - Navigation Page: Add SSI Tab Add SSI Forms: This tab only appears on the REC, R&D and GTAC forms. Selecting this tab allows you to add individual Site Specific Information (SSI) forms to your project.

47. Add SSI Tab Quick Run through of the Tabs - Navigation Page: SSI Tab Change number of forms needed here Click here to add new SSI forms SSI forms are displayed here

48. Task: Please now create three new SSI forms.

49. How to create an amendment application form

50. Amendment Tab Quick Run through of the Tabs - Navigation Page: Amendment Tab Amendment Tab: Once you have submitted an ethics form, and providing it is not a clinical trial of a medical product, you will be able to raise amendment forms for ethics. Guidance on amendment procedures for other forms will be found under these tabs as available

51. Amendment Tab Quick Run through of the Tabs - Navigation Page: Amendment Tab To submit an amendment click on the REC form

52. Amendment Tab Quick Run through of the Tabs - Navigation Page: Amendment Tab Click here to create a substantial amendment form

53. Amendment Tab Quick Run through of the Tabs - Navigation Page: Amendment Tab Click here to fill in the form Amendment forms are now listed here

54. Amendment Tab Quick Run through of the Tabs - Navigation Page: Amendment Tab Treat the Form just like any other. Complete the questions. Click the tick to mark the questions as complete, proceed by clicking next. Save by clicking save

55. Task: Please now create an amendment form but do not fill in any of the details

56. How to Create a Checklist

57. Checklist Tab Quick Run through of the Tabs - Navigation Page: Checklist Tab Once you have Checklist Tab: This tab will take you through a submission checklist for that particular form A different checklist will appear depending on which form you have selected

58. Checklist Tab Quick Run through of the Tabs - Navigation Page: Checklist Tab Once you have A different checklist will appear depending on which form you have selected Click next to each relevant document to amend information

59. Checklist Tab Quick Run through of the Tabs - Navigation Page: Checklist Tab Once you have A different checklist will appear depending on which form you have selected Once information has been added click the green tick to accept or the red cross to cancel

60. Checklist Tab Quick Run through of the Tabs - Navigation Page: Checklist Tab Once you have A different checklist will appear depending on which form you have selected Click on these icons to create another document with the same title.

61. Checklist Tab Quick Run through of the Tabs - Navigation Page: Checklist Tab Once you have A different checklist will appear depending on which form you have selected Click here to add documents to the checklist that are not included above

62. Checklist Tab Quick Run through of the Tabs - Navigation Page: Checklist Tab Once you have A different checklist will appear depending on which form you have selected Click here to print or save your checklist. Checklists are required for the R&D Form, Each SSI Form and the REC Form

63. Please complete Task 3

64. Authorising Forms

65. Authorisations Tab Quick Run through of the Tabs - Navigation Page: Authorisation Tab Authorisations: It is possible to obtain electronic authorisations rather than ‘ink’ signatures for the roles shown on the authorisations page. The person authorising the form must have an IRAS account.

66. Authorisations Tab Quick Run through of the Tabs - Navigation Page: Authorisation Tab Authorisations: It is possible to obtain electronic authorisations rather than ‘ink’ signatures for the role shown on the authorisations page. The person authorising the form must have an IRAS account. You can sign the forms yourself if you are the Sponsor or Chief Investigator by clicking here This section shows you which form you are authorising.

67. Authorisations Tab Quick Run through of the Tabs - Navigation Page: Authorisation Tab Authorisations: It is possible to obtain electronic authorisations rather than ‘ink’ signatures for the role shown on the authorisations page. The person authorising the form must have an IRAS account. If you are the Chief investigator or sponsor complete the questions and click the sign button. This will add your electronic signature to the form you are currently filling in.

68. Task: Please sign the Chief Investigator’s part of the form.

69. Authorisations Tab Quick Run through of the Tabs - Navigation Page: Authorisation Tab Authorisations: It is possible to obtain electronic authorisations rather than ‘ink’ signatures for the role shown on the authorisations page. The person authorising the form must have an IRAS account. Authorisation has been given. You can cancel an authorisation by clicking the revoke button

70. Task: Please revoke the signature

71. Authorisations Tab Quick Run through of the Tabs - Navigation Page: Authorisation Tab Authorisations: It is possible to obtain electronic authorisations rather than ‘ink’ signatures for the role shown on the authorisations page. The person authorising the form must have an IRAS account. If the Sponsor or Chief Investigator for this project have an IRAS account you can send them a request to electronically sign the form you are working on by clicking the request button. This section shows you which form you are getting authorisation for.

72. Authorisations Tab Quick Run through of the Tabs - Navigation Page: Authorisation Tab Authorisations: It is possible to obtain electronic authorisations rather than ‘ink’ signatures for the role shown on the authorisations page. The person authorising the form must have an IRAS account. You will need to add the sponsor or chief investigators’ email address and press the send request button. They will then be able to authorise your request in their ‘My Projects’ page

73. Transferring a Project

74. Transfer Tab Quick Run through of the Tabs - Navigation Page: Transfer Tab Transfer Tab: Allows you to send a form to another IRAS user. You must use the email address that the other IRAS user is registered with in order for the system to find the other user. Sending your form will allow the other person to check through the form and make amendments if need be. Enter the other IRAS users email address and press the ‘Transfer to User’ button to send your project. This shows which form you will be sending

75. Save and Print Tab

76. Save/Print Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Save/Print Tab: This tab explains the processes which must be followed in order to print or save a DRAFT copy of your form onto your computer. The forms will have the text DRAFT written across them. I will cover how to do this in the submission tab as the process is the same

77. Saving Your Completed Form to Your Computer

78. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Submission: This tab details the information and process you need to carry out in order to submit the selected form to the appropriate regulatory body. This should be done once you are 100% happy that your forms are correct and completed. Submission just means saving your forms onto your Computer

79. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Select the form you wish to submit

80. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Clicking here will show you if you have completed all the questions

81. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Click here to start saving your application

82. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Click ok

83. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Click continue

84. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Click on the yellow box and click download file

85. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Click save

86. Task: Save one of your IRAS forms onto your computer desktop

87. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Once you have saved your document onto the computer the option will appear to save it as an XML file. You will only need an XML file for your SSI & R&D Forms. The SSI & R&D Form XML files will need to be included in your submission. Click “Save Completed Form as XML” button

88. Submission Tab Quick Run through of the Tabs - Navigation Page: Save/Print Tab Click Export and save XML document onto your computer

89. Task: Save an XML file onto your computer desktop

90. Quick Run Through of Menu Options

91. My Contacts

92. Menu Options Quick Run through of the Menu Options – My Contacts Click here to access ‘My Contacts’

93. Menu Options Quick Run through of the Menu Options – My Contacts Once you have clicked the ‘My Contacts’ button you are taken to the ‘My Contacts’ page

94. Menu Options Quick Run through of the Menu Options – My Contacts You can search for a contact by typing in their details and pressing the looking glass icon

95. Menu Options Quick Run through of the Menu Options – My Contacts To Add a contact press the ‘Add contact’ button

96. Menu Options Quick Run through of the Menu Options – My Contacts The ‘My Contact’ page will allow you to add a contact. Type in their details and press the ‘Add contact’ button. You can use your saved contacts when filling in your IRAS forms as they can be imported from ‘My Contacts’

97. My Account

98. Menu Options Quick Run through of the Menu Options – My Account Click here to access ‘My Account’

99. Menu Options Quick Run through of the Menu Options – My Account Click here to access ‘My Account’ You can edit your account details and password on the ‘My Account’ page

100. Menu Options Quick Run through of the Menu Options – My Account Click here to access ‘My Account’ You can also create or edit your C.V. which can be printed to go with your research forms

101. Menu Options Quick Run through of the Menu Options – My Account Click here to access ‘My Account’ Clicking here will allow you to make the website text larger or smaller

102. E-Learning, Help & Contact Us Tabs

103. Menu Options Quick Run through of the Menu Options – E-Learning Click here to access ‘E-Learning’

104. Menu Options Quick Run through of the Menu Options – Help Click here for ‘Help’ this page will give you IRAS manuals, example application forms and frequently asked questions

105. Menu Options Quick Run through of the Menu Options – Contact Us Click here to ‘Contact Infonetica’ for technical support

106. Log Out

107. Menu Options Quick Run through of the Menu Options – Logout Click here will log you out of IRAS

108. Any Questions?

109. If you have any questions or problems when you begin using IRAS please give me a ring on 01633 656353