TRAINING MANUAL Using IRAS (Integrated Research Application System) - - PDF document

R&D Training Manual – IRAS & Setting Up Your Research Study Page 0 March 2015

TRAINING MANUAL

Using IRAS

(Integrated Research Application System)

& Setting Up Your Research Study

R&D Training Manual – IRAS & Setting Up Your Research Study Page 1 March 2015

Contents

Page Section 1 – Overview of IRAS ……… What is IRAS ……… 3 How does IRAS work? ……… 3 What is IRAS used for? ……… 3 Creating an account ……… 4 Accessing your account ……… 4 - 5 IRAS account tabs ……… 5 Section 2 – Creating a New Project ……… Creating a new project ……… 7 Project Filter ……… 7 Data Set ……… 7 – 8 Forms ……… 8 - 9 Section 3 – SSI Submissions ……… Adding SSI‟s ……… 11 Accepting SSI‟s ……… 11 Completing SSI‟s ……… 12 Form Contact Data ……… 12 – 13 Transferring Forms ……… 13 – 14 Checklists ……… 15 – 16 Authorisations ……… 16 – 18 Submission ……… 18 – 19 Saving Forms ……… 19 - 20 Approvals ……… 20 Section 4 – How IRAS Fits into the Feasibility Process ……… R&D Set-Up Process ……… 22 Feasibility Form ……… 22 Approvals / Time Lines ……… 23 Additional Authorisations ……… 23 Additional Internal Governance Requirements ……… 23 Section 5 – R&D Support ……… R&D Support ……… 25 Section 6 – Hints & Tips ……… Hints & Tips ……… 27 Appendices ……… Appendix 1 – R&D Set-Up Process ……… 29 Appendix 2 – Example of a Feasibility Form ……… 30-32 Appendix 3 – Training Presentation ……… 33 - 68

R&D Training Manual – IRAS & Setting Up Your Research Study Page 2 March 2015

Section 1 Overview of IRAS

(Integrated Research Application System)

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What is IRAS? The IRAS website is www.myresearchproject.org.uk and anyone can create an account for free. IRAS is the Integrated Research Application System Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK Enables applicants to enter the information about their study once instead of duplicating information in separate application forms 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 applicants to meet regulatory and governance requirements Designed to capture the information needed to be submitted by researchers for the relevant permissions and approvals for health and social care / community care research in the UK How does IRAS work? Consists of a single dataset (i.e. a set of questions and answers) for all the questions in all the application forms included in the system

• Answer the filter questions - completing the project filter tailors the data collected

to the type of research study by disabling questions and sections that are not relevant

• Complete information about the study - information about the study can be added

to the “integrated dataset” or in the individual application forms that have been

• generated. The information cross-populates so each question only needs to be

answered once. Guidance is available throughout the system to help and support users in completing information and using IRAS

• Submit application(s) - once information has been entered about the study and

any relevant authorisations on applications forms made the application form(s) are ready to be submitted What is IRAS used for? IRAS can be used to apply to the following review bodies:

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• Ministry of Justice
• NHS / HSC R&D offices
• NHS / HSC Research Ethics Committees
• National Offender Management Service (NOMS)
• Social Care Research Ethics Committee
• Gene Therapy Advisory Committee (GTAC)
• Confidentiality Advisory Group (CAG), formerly the National Information

Governance Board (NIGB)

R&D Training Manual – IRAS & Setting Up Your Research Study Page 4 March 2015

Creating an account Go to: https://www.myresearchproject.org.uk/ Select: Enter Select: Create Account Answer questions shown on screen – use an email address that you use all the time (e.g. work email) as it will be this address that you will receive all notifications from IRAS Your email address that you enter should be accurate in order to receive the automated activation email - if you do not receive the automated email after about 1 hour telephone the helpdesk/helpline for assistance (IRAS Technical Helpdesk

• n

0207 043 0734

• r

email them at helpdesk@myresearchproject.org.uk. The IT Help Desk operates (9am to 5pm excluding holidays and weekends). You will need to create a password that includes both letters and numbers. Accessing your account Go to: https://www.myresearchproject.org.uk/ Login – use your email account

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Password – this is created when you set up your new account You will be taken to My Projects screen IRAS Account Tabs

• Home - front page with news about updates to the system
• My Projects - list of studies
• My Contacts - telephone book of contacts that can be built up
• My Documents – ability to save and store your own documents
• My Account - create and edit your CV
• E-Learning - training module for IRAS
• Help - help desk and FAQs for problems you may encounter
• Contact Us - contact information if you experience problems with IRAS
• Logout - always log out of IRAS

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Section 2 Creating a New Project

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Creating a New Project

• Log into your account
• You will be taken to the 'My Projects' screen
• Click on “New Project” – this will generate a Project Filter

Project Filter

• Complete Project Filter questions accurately in IRAS to create the dataset
• Use the green information icons for assistance in answering the questions
• Ability to amend the filter and re-save at any point prior to submission
• Amendment of Project Filter will add/delete questions

Dataset

• Save the Project Filter, click on the “Navigate” button and you will be directed to

the full dataset

• Only questions relevant to the study will be accessible
• The tabs along the top apply to the whole project. If you click on a specific form in

the left-hand column, then the tabs will only apply to that form

If you complete this section incorrectly, invalid questions appear on the dataset for the study

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Sections of the dataset consist of:

• Part A - Core Study Information
• Part B, Section 1 - Investigational Medicinal Products
• Part B, Section 2 - Medical Devices
• Part B, Section 3 - Ionising Radiation
• Part B, Section 4 - Existing Tissue Samples
• Part B, Section 5 - New Tissue Samples
• Part B, Section 6 - Adults Unable to Consent
• Part B, Section 7 - Children
• Part B, Section 8 - NIGB Information
• Part B, Section 9 - Information Security
• Part B, Section 10 - National Offenders Management Service Information
• Part C - Research Sites and Investigators
• Part D - Declarations
• SSI Forms - Site Specific Information

The R&D and REC forms provide general „study-wide‟ information about the

• research. The SSI Form provides „Site Specific Information‟, hence why one SSI

Form is required for each individual NHS Trust. The currently selected form can be identified as it will be highlighted with a blue background and the form name will appear on the Project Information Bar and on headers in the tab sections. Forms Once inside a form, you can move around it using the following buttons which are available at the top and the bottom of the form page. Depending on which form you are in i.e. Project Filter or R&D form, depends on which tabs are available and which

• rder they appear in:
• Navigate - will save your changes and take you back to the Project

Index/Navigate page. You can quickly access other parts of this form from that page − or access another form in your project

• Add SSI – to add relevant number of SSIs for each study. All studies will have a

minimum of one SSI

• Amendments – for submission of amendments for a study
• Checklist – required for each of the forms
• Submission – unique IRAS code is allocated
• Electronic submission for Portfolio studies which sends checklist, form and

study documentation direct to the CSP Unit

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• Manual submission for non-Portfolio studies – email needs to be sent to

relevant organisation attaching checklist, form (in XML and PDF format) and study documentation

• Transfer – form is sent electronically to another person for completion but leaves

your account and you no longer have access to the form

• Authorisations – obtain electronic signatures of CI/PI/Sponsor etc
• Save/Print – allows you to save and print your form prior to submission. Cannot

be used for submission as will have DRAFT written through each page and you must use the 'Submission' tab from the Project Index/Navigate page for that purpose

• Save Now - this will save changes to the current page of the form. It is strongly

advised that you click this before leaving your work for any sustained period of time

• Previous and Next - these buttons will save your current changes and move you

to the previous questions or next questions in that form

• Manage – can duplicate, delete or export the SSI form

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Section 3 SSI Submissions

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Adding SSI’s SSI forms are required for all projects (single and multi-site). In order to create an SSI form:

• Ensure that the NHS Trust is listed in part C of the R&D form
• Some information in the SSI form will already be populated from main data set
• Select R&D form to add SSI forms
• Type in the number of SSIs to be added

Accepting SSI’s If South Tees are only „hosting‟ a research site, then the standard process is for the coordinating centre to create the SSI Form and transfer this to the PI/Research Nurse for completion.

• You will receive an email notification from IRAS

Example of email title: IRAS Transferring "NHS SSI - 259992 [No PI typed (No research organisation typed)]“

• Open the email
• Log in to IRAS via the link on the email
• Open the project
• Click “Accept”

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Completing SSI’s

• Enter the information into one SSI Form and then create as many duplicates as

required

• From the NHS REC form or NHS R&D Form, click on the Add SSI tab
• Enter the number of SSI Forms required
• Click on the SSI Form that has appeared within the tab
• Q1-1 - always use South Tees Hospitals NHS Foundation Trust
• Q3 - add all areas where the research will take place including the Friarage

Hospital (where applicable)

• Q7 - start date to be listed as after the date of submission of study
• Q8-1 - to be completed fully
• Q9-1 - to be completed fully
• Q10 - recruitment figures to be realistic – use figure stated on the feasibility form.

It is important to ensure that this figure has been agreed with relevant parties (PI, R&D team) and reflects the number in the study contract (if applicable)

• Q15-1 – use the Trust R&D Department contact details
• Q15.2 - insert local contact details for study team or contact details for co-
• rdinating centre as appropriate
• Q23 - ensure that you have spoken to R&D Manager or Assistant Manager

before completing this section, then tick the check box Form Contact Data IRAS comes with an integrated contacts database under the My Contacts link on the main menu bar. The form allows you to save contacts you have filled in on the form into your contacts database, or fill the form in with contacts from your database. On each contact form field you will see a set of icons (shown below). The 'Select Contact' icon allows you to fill the form from your saved contacts (contact database) and the 'Save details to MyContacts' icon enables you to save a contact that you have filled in on the form into your saved contacts. To copy a contact's information into the form fields from your contacts database:

• Click on the 'Contact Icon' which will open a new window with your contact data
• Select 'View' next to the appropriate contact (1) - this will put their details in the

same window on the right hand side

• Verify this is the correct contact, click on 'Copy Contact Details into Form' (2)

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The window will close and the details will be populated. If you have filled in the contact fields in the form and wish to add this contact to your database, then click on the 'Save details to My Contacts' icon. It will ask you to confirm this action and if you agree the contact will be added to your contacts database.

• Adding a Contact - click on the link 'Add Contact' and filling in the appropriate
• details. If you have entered a contact into a form but wish to change it, the

contact information can be overwritten by clicking on the 'Add Contact Details' icon and selecting a new contact from the contact database.

• Editing a Contact - to edit a contact in your contact list, click the 'View' link. This

will display the contact details on the right hand side, from where they can be

• edited. Once you have finished editing the details − click the 'Update' button to

save the changes.

• Deleting a Contact - to delete a contact in your contact list, click the 'View' link.

This will bring the contact details on the right hand side. At the bottom of the details you will see the link 'Delete' clicking on this will delete the contact. You will be asked to confirm the deletion before the contact is actually deleted from the database. Transferring Forms IRAS allows you to transfer forms to other users that have registered accounts on the IRAS system. To do this, select a form then click on the 'Transfer' tab. You will then have to put in the email address of the user you wish to transfer the form to. Note that the system cannot transfer to a person without an IRAS account as the form is not emailed − it is transferred securely within the IRAS system.

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Once you press the transfer button a number of tabs will disappear. This is because you cannot edit a form unless you have control over it. As an owner of a form, you can always reclaim it by clicking on the transfer tab, and then clicking on the 'Retrieve Application' button. This will immediately return the form to your control. The person receiving the form will receive an email saying you are trying to transfer a form to them. When they log on to their account, they will see the form pending transfer in their form list. The user receiving the form will be given the choice to either accept or reject the transfer after clicking on the Open Project link. If they reject the transfer the form is returned to your control.

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Checklists

• To be completed for all studies once SSI has been completed but prior to

requesting authorisations

• Required for REC, R&D and SSI submissions
• For submissions electronically (E-submission) documents can be attached to the

checklist

• For submission manually documents cannot be attached but the Checklist should

still be completed

• Select the checklist tab associated with the application being prepared for

submission e.g. R&D, Ethics

• On the checklist tab you will be able to confirm that documents can be

electronically submitted by text at the top of the page and by the paperclip icon being present on the right hand side of the table of checklist items

• Documents and files that require electronic submission with the application form

must be attached to the checklist for the application To attach a file to the checklist:

• Click on the paperclip icon in the right hand column of the row for the document

you wish to submit

• Select the document to upload and enter details about it
• Select where you want to upload the document from
• Click the „Upload document‟ button
• A new window will show a summary of the details
• Select „Close‟ to return to the checklist and select another document

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If you need to add multiple documents of the same type, you should use the button to add further rows of that document type to the checklist To remove a file:

• Click the paperclip icon for the document you wish to remove
• An „Update Document‟ window where you can either upload a different file to

replace the one you have, or you can delete the file will appear If there are items in the checklist that are not applicable to your study, that will be sent after submission of your application or which are being submitted by another means you should indicate this in the checklist in the „reason not supplied‟ column. Once the check list has been completed (for manual submission) and all documents to be electronically submitted with the application have been uploaded, return to the authorisation tab for your application. Authorisations Relevant authorisations must be obtained before selecting "Proceed to Submission". If changes are made to the dataset/forms/checklist after authorisation, the authorisation is invalidated, eliminating the possibility of forms being submitted that have been changed after authorisation.

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• The appropriate form, e.g. the R&D form, must be selected in order to access the

authorisation function

• Electronic signatures via IRAS accounts for CI/PI, Academic Supervisor, Sponsor

Representative,

• SSI forms can only be signed electronically
• All signatories will need to have an IRAS account

Obtaining electronic authorisations:

• Select the relevant form that requires authorisation
• Select the “Authorisations” tab on the right hand side of the page
• Tab indicates all authorisations required for that form, for that project
• Select relevant type of authoriser (e.g. sponsor)
• Click “Request” button
• Dialogue box appears – type in authoriser‟s email address
• Click “Send Request”
• Authoriser receives an email from IRAS requesting that they authorise the form

with a link to log in

• Authoriser logs into IRAS - the main project page will contain a “Requests for

Authorisation” section below any projects they own

• Authoriser clicks “Review Requested Form”
• Authoriser clicks on “Navigate” to view the application data in read−only format
• Authoriser happy with the form - Clicks “Authorise Form”, enters their details,

clicks “Sign”

• Applicant will receive an email from IRAS confirming the authorisation
• Declaration section will contain the text: “This section was signed electronically

by [name] on [date, time]”

• Authoriser can “Reject Request”. Applicant will receive an email from IRAS

confirming that the request to authorise was rejected. The applicant to liaise directly with the authoriser to resolve the issue

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• An auditable record is produced on the system of what has been

authorised/rejected, when and by whom.

• IRAS sends an email back to the applicant (project owner) confirming

authorisation or rejection Submission Applications should not be submitted until the checklist has been completed and the forms have been fully authorised. A separate submission needs to be made for each form (REC, R&D, SSI) and depending on the submission, either an E-Submission Tab or Submission Tab will be visible:

• E-Submission – submission of the form, checklist and study documentation is

sent electronically via IRAS

• Manual Submission – all information remains in your account and the checklist,

form and documentation will need to be sent in a separate email To make an E-Submission:

• Click on E-Submission Tab
• Do not check your form as this could invalidate the authorisation
• Follow all the other instructions on the page
• Click on “SSI E-Submission” button
• If sent in error, submission can be recalled by clicking on the “Recall” button
• Submission history/status is shown at the bottom of the page

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To make a manual submission:

• Click on Submission Tab
• Do not check your form as this could invalidate the authorisation
• Follow all the other instructions on the page
• Click on “SSI Submission” button
• If sent in error, submission can be recalled by clicking on the “Recall” button
• Submission history/status is shown at the bottom of the page
• Attach XML and PDF of form, checklist and study documentation (as per the

checklist) in an email and send to CSP Unit/R&D Saving Forms as PDF & XML

• Select form to save i.e. R&D or SSI form
• Select Submission Tab
• Scroll to Submission History at the bottom of the page

PDF

• Select “Print as PDF”
• Dialogue box appears – click “Continue”
• Dialogue box appears – click “Here”

R&D Training Manual – IRAS & Setting Up Your Research Study Page 20 March 2015

• Form will open up in PDF format
• Print and/or save
• Close form
• Close dialogue box

XML

• Select “Save as XML”
• Dialogue box appears – click “Export”
• Dialogue box appears – click “Save” – do not open the file at this point as it

may corrupt the data

• “Save As” dialogue box opens
• Save document
• Close dialogue box

Approvals

• Most projects at South Tees require approval from:
• NHS R&D office
• Research Ethics Committee
• Some projects („CTIMPs‟) also require approval from the MHRA.
• There are some exceptions to the requirement for ethics approval (e.g. research

that does not involve patients as participants). Also both research ethics and the MHRA have „proportionate‟ review processes for lower-risk projects.

• At South Tees Hospitals, the R&D Permission Letter is issued after these other

regulatory approvals are in place (if required). Required application forms: Approval body Application requirements NHS Research Ethics Committee

• REC application form
• Study documents
• Book onto and attend a committee

meeting MHRA

• EudraCT application form
• Study documents
• Application fee

NHS R&D office

• R&D application form*
• SSI application form
• Study documents*

* You do not need to provide the R&D application form or the „study-wide‟ documents if you are hosting an NIHR Portfolio study

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Section 4 How IRAS Fits into the Feasibility Process

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R&D Set-Up Process Feasibility Form The feasibility form is a tool to identify the set-up and support requirements for new potential studies. It should be completed prior to the submission of an application for approval and is only 2 pages long and is designed as a “checklist”. The form allows you to:

• Request R&D support (e.g. in accessing statistical support, resolving resource

concerns etc)

• Identify which support services are required
• Highlight your proposed time line for starting the research
• Receive feedback on whether the recruitment target is realistic
• Prepare for the „70 day‟ PID target

If you have a study on the horizon, please arrange a meeting with Joe Millar or Trish Mitcheson & we can complete this form together. Alternatively if it is not possible to meet, then you can complete the form remotely and email to researchdevelopment@stees.nhs.uk for review. A copy of the form is available on the R&D intranet: or can be obtained by contacting the R&D office. R&D will use the completed form to advise on the submission timeline and the next steps for completing the set-up process. Agree next steps and timeline IRAS submission R&D review & SIV Sponsor green light 1

st patient randomised

Complete feasibility form Less than 70 days

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Approvals / Time Lines

• On receipt of the SSI, R&D have 15 days to carry out the governance review

NB: A new HRA approval process will be introduced in the future, which will reduce the requirements for „governance review‟ at NHS Trusts. Further info at: http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment- approval/; R&D will communicate any updates.

• Clinical trials (CTIMPs, Medical Devices, RCTs and Other CTs) are reported on

every quarter as part of „PID‟.

• The research team for clinical trials have 70 days to recruit their first patient from

the valid research application (i.e. SSI submission) – hence the importance of early discussion with R&D to pre-empt potential delays in randomising patients. Additional Authorisations

• Authorisation from the Clinical Director or Chief of Service via their email account.

CIs/PIs cannot sign off their own studies

• Studies which require „additional‟ support from Pharmacy, Pathology or

Radiology (SOPs 16, 17, and 18 - available on the R&D intranet) require a hard, signed copy or electronic copy of the relevant Mutual Co-Operation Agreement. If electronic then require an email trail between PI/Research Nurse to the Support Service concerned to indicate that discussions have taken place.

• Studies which only require „routine‟ support from Pharmacy, Pathology or

Radiology should be notified to the relevant contact (via email) for their

• awareness. A Mutual Co-Operation Agreement is not required.

Additional Internal Governance Requirements

• CTIMP studies - CV‟s for PI and research team members
• CTIMP studies – GCP certificates for PI and research team members
• Non-CTIMP studies - CV‟s for PI and research team members
• Non-CTIMP studies - GCP certificate for PI
• Declaration of Understanding (for new PIs or those who have updated their

GCP training

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Section 5 R&D Support

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R&D Support R&D operate an open door policy. If you have any queries regarding the feasibility form or IRAS, in the first instance contact: 1) Joe Millar, Assistant R&D Manager Contact Information: External: 01642 835986 Internal: Ext - 55986 Email: joe.millar@stees.nhs.uk

• r

2) Trish Mitcheson, R&D Facilitator Contact Information: External: 01642 282585 Internal: Ext - 52585 Email: trish.mitcheson@stees.nhs.uk

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Section 6 Hints & Tips

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Hints & Tips

• Use the green information icons for each of the questions
• Do not amend forms/checklists once authorisations have been requested as any

amendments will invalidate the authorisations

• Do not submit forms until discussions have taken place with R&D
• Ensure timelines are realistic
• Complete the feasibility form prior to accepting the study or making a study

submission for approval

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Appendices

Appendices Page Appendix 1 - R&D Set-Up Process ……………………… 29 Appendix 2 – Example of a Feasibility Form ……………………… 30 - 32 Appendix 3 – Training Presentation ……………………… 33 - 68

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Appendix 1 R&D Set-Up Process Agree next steps and timeline IRAS submission R&D review & SIV Sponsor green light 1

st patient randomised

Complete feasibility form Less than 70 days

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Appendix 2 Example of a Feasibility Form

Please complete this form prior to the submission of the Site Specific Information (SSI) and send to researchdevelopment@stees.nhs.uk. If you would prefer to complete this form with the support of the R&D department, please contact researchdevelopment@stees.nhs.uk to arrange a meeting. Please leave any questions blank if the requested information is not applicable. Requested info Response

Study title Is this an NIHR CRN portfolio study?

Yes / No / Not sure

NIHR CRN portfolio number (if known) Type of study (e.g. „clinical trial‟, „questionnaire study‟ etc) Sponsor organisation (if known)

(If you would like to apply for the Trust to act as Study Sponsor, please state here)

Principal Investigator (if known)

Name: Email: Phone:

Trial Co-ordinator (if known)

Name: Email: Phone:

Proposed date for Site Initiation Visit (if applicable) Proposed date for starting the research Proposed date for completing the research Target No for local recruitment When estimating this, please consider: The study eligibility criteria Anticipated interest in the study from patients (Please mention how this target has been calculated. Please highlight if would like to receive any additional data or support from the R&D team.)

R&D Training Manual – IRAS & Setting Up Your Research Study Page 31 March 2015 Existing numbers of patients that are seen (taking any fluctuations into account) Staff availability, annual leave etc Restrictions in the Protocol How much work do you estimate will be required to: Tick box

Comments (optional)

High Medium Low

None

Identify & screen patients? Carry out data collection? Carry out “follow-up” work Is any support required from the following Clinical Support Services? Tick box

Comments (optional) Contact Person

Additional Routine None Pathology

Gill.Wheater@stees.nhs.uk

Radiology

Brian.Cox@stees.nhs.uk

Pharmacy

Jason.wong@stees.nhs.uk

Other support services

(e.g. ECG, ophthalmology)

If unsure, contact researchdevelopment@stees. nhs.uk

If additional support is required, please email a „Mutual Cooperation Agreement' to the listed contact (for their approval). If routine support is required, please email the study details to the listed contact (for their information only).

Will any of the following issues affect the study? Tick box Comments (optional) Will there be a significant delay between consent and randomisation of patients? Restrictions on when the research can be carried out (e.g. procedure is „out of hours‟) Transfer of images (not involving radiology) Training requirements Clash with other studies Conflict of workload Additional financial support and/or equipment is

R&D Training Manual – IRAS & Setting Up Your Research Study Page 32 March 2015 required Other delays anticipated (e.g. study supplies will need to be released) If data will be sent outside of the Trust, please answer the following questions: How is data collected?

Case Report Form Other (please specify)

Will patient identifiable data be sent?

No Yes (please specify)

How does data leave the Trust?

Post NHS.net email transfer Online database Other (please specify)

If an online database will be used, what is the web address?

Any other comments (PI / Research Nurse) Completed by: Date:

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Appendix 3 Training Presentation

Using IRAS & Setting Up Your Research Study

Presentation overview: 1) Overview of IRAS 2) Creating your own IRAS project 3) SSI submissions 4) How IRAS fits into feasibility process and timelines

1) Overview of IRAS

(Integrated Research Application System)

What is IRAS?

• IRAS is the Integrated Research Application System
• Is a single system for applying for the permissions and

approvals for health and IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK

• Enables applicants to enter the information about their study
• nce instead of duplicating information in separate application

forms

• Uses filters to identify which application forms need to be

completed, and to ensure that only relevant data is collected in these forms

• IRAS website is www.myresearchproject.org.uk and anyone

can create an account for free

How does IRAS work?

• It consists of a single dataset (i.e. a set of questions and

answers) for all the questions in all the application forms included in the system.

• The set of questions that need to be answered by a researcher

will depend on the type of study and the types of applications required

• The actual application forms for each reviewing body are

generated from the single dataset, i.e. all the forms cross- populate

• There are separate application forms but only one set of

questions

IRAS can be used to apply to the following review bodies:

• Administration of Radioactive Substances Advisory Committee

(ARSAC)

• Medicines and Healthcare products Regulatory Agency (MHRA)
• Ministry of Justice
• NHS / HSC R&D offices
• NHS / HSC Research Ethics Committees
• National Offender Management Service (NOMS)
• Social Care Research Ethics Committee
• Gene Therapy Advisory Committee (GTAC)
• Confidentiality Advisory Group (CAG), formerly the National

Information Governance Board (NIGB)

• Most projects at South Tees require approval from:
• NHS R&D office
• Research Ethics Committee
• Some projects (‘CTIMPs’) also require approval from the MHRA.
• There are some exceptions to the requirement for ethics

approval (e.g. research that does not involve patients as participants). Also both research ethics and the MHRA have ‘proportionate’ review processes for lower-risk projects.

• At South Tees Hospitals, the R&D Permission Letter is issued

after these other regulatory approvals are in place (if required).

Required application forms: Approval body Application requirements NHS Research Ethics Committee

• REC application form
• Study documents
• Book onto and attend a

committee meeting MHRA

• EudraCT application form
• Study documents
• Application fee

NHS R&D office

• R&D application form*
• SSI application form
• Study documents*

* You do not need to provide the R&D application form or the ‘study-wide’ documents if you are hosting an NIHR Portfolio study

IRAS Account

• The IRAS website is www.myresearchproject.org.uk
• Anyone can create an account for free

Tabs:

• Home – front page with news about updates to the system
• My Projects – list of studies
• My Contacts – telephone book of contacts that can be built up
• My Documents – ability to save and store your own documents
• My Account – create and edit your CV
• E-Learning – training module for IRAS
• Help – help desk and FAQs for problems you may encounter
• Contact Us – contact information if you experience problems

with IRAS

• Logout – always log out of IRAS

2) Creating a new project

• Click on “New Project” – this will generate a Project Filter

Project Filter

• Complete Project Filter questions accurately in IRAS to create the

dataset – it is possible to amend the filter and re-save If you complete this section incorrectly, invalid questions appear on the dataset for the study

Dataset

• Save the Project Filter, click on the “Navigate” button and you will be

directed to the full dataset

• Only questions relevant to the study will be accessible
• The tabs along the top apply to the whole project. If you click on a

specific form in the left-hand column, then the tabs will only apply to that form

Dataset

• Part A - Core Study Information
• Part B, Section 1 – Investigational Medicinal Products
• Part B, Section 2 - Medical Devices
• Part B, Section 3 - Ionising Radiation
• Part B, Section 4 - Existing Tissue Samples
• Part B, Section 5 - New Tissue Samples
• Part B, Section 6 - Adults Unable to Consent
• Part B, Section 7 - Children
• Part B, Section 8 - NIGB Information
• Part B, Section 9 - Information Security
• Part B, Section 10 - National Offenders Management Service Information
• Part C - Research Sites and Investigators
• Part D – Declarations
• SSI Forms – Site Specific Information

Dataset

• The R&D and REC forms provide general ‘study-wide’ information about

the research.

• The SSI Form provides ‘Site Specific Information’, hence why one SSI

Form is required for each individual NHS Trust.

3) SSI Submissions

Creating an SSI form

• SSI forms are required for all projects (single and multi-site)
• In order to create an SSI form:
• ensure that the NHS Trust is listed in part C of the R&D form
• Click on the ‘add SSI’ tab and follow the instructions
• Some information in the SSI form will already be populated from the main

data set

Accepting SSI’s

• If we are only ‘hosting’ a research site, then the standard process is for

the coordinating centre to create the SSI Form and transfer this to the Research Nurse for completion

• Email notification will be received by the individual (e.g. IRAS Transferring

"NHS SSI - 259992 [No PI typed (No research organisation typed)]“)

• Log in to IRAS via the link on the email, open the project and accept

Tabs

• Navigate – takes you back to your dataset grid
• Checklist – required for each of the forms
• Submission – submits the study and gives it an unique IRAS code

number

• Manage – can duplicate, delete or export the SSI form
• Transfer – form is sent to another person for completion but leaves your

account and you no longer have access to the form

• Authorisations – electronic signatures of CI/PI/Sponsor etc
• Save/Print – allows you to save and print your form prior to submission.

Cannot be used for submission as will have DRAFT written through each page

Completing SSI’s

• Q1-1 - Always use South Tees Hospitals NHS Foundation Trust
• Q3 – Add all areas where the research will take place including the

Friarage Hospital (where applicable)

• Q7 - Start date to be listed as after the date of submission of study
• Q8-1 – to be completed fully
• Q9-1 – to be completed fully

Completing SSI’s (continued)

• Q10 – Recruitment figures to be realistic – use figure stated on the

feasibility form. It is important to ensure that this figure has been agreed with relevant parties (PI, R&D team) and reflects the number in the study contract (if applicable)

• Q15-1 - Use the Trust R&D Department contact details
• Q15.2 - Insert local contact details for study team or contact details for

co-ordinating centre as appropriate

• Q23 – ensure that you have spoken to R&D Manager or Assistant

Manager before completing this section then tick the check box

Checklist

• The ‘checklist’ tab shows which documents need to be submitted with the

application forms. The R&D and SSI forms each have separate checklists.

• Please ensure to attach any applicable documents – you can do this

using the paperclip icon.

Authorisations

• Relevant authorisations must be obtained before selecting "Proceed to

Submission".

• If changes are made to the data after authorisation, the authorisation is

invalidated, eliminating the possibility of forms being submitted that have been changed after authorisation.

• Electronic signatures via IRAS accounts for CI/PI, Academic Supervisor,

Sponsor Representative

• SSI forms can only be signed electronically
• All signatories will need to have an IRAS account

Submission

• Applications should not be submitted until the checklist has been

completed and the forms have been fully authorised

• Separate submissions need to be made for each form (REC, R&D, SSI)
• Depending
• n

the submission, either an E-Submission Tab

• r

Submission Tab will be visible

• E-Submission

– submission

• f

the form, checklist and study documentation is sent electronically via IRAS

• Manual Submission – All information remains in your account and the

checklist, form and documentation will need to be sent in a separate email

4) How IRAS fits into the feasibility process

R&D set-up process

Agree next steps and timeline IRAS submission R&D review & SIV Sponsor green light 1st patient randomised Complete feasibility form Less than 70 days

Feasibility form The feasibility form is a tool to identify the set-up and support requirements for new potential studies. The feasibility form allows you to:

• Request R&D support (e.g. in accessing statistical support, resolving

resource concerns etc)

• Identify which support services are required
• Highlight your proposed time line for starting the research
• Receive feedback on whether the recruitment target is realistic
• Prepare for the ‘70 day’ PID target

R&D will use the completed form to advise on the submission timeline and the next steps for completing the set-up process.

Feasibility form

• This form should be completed prior to the submission of the SSI. It is
• nly 2 pages long and designed as a ‘checklist’.
• If you have a study on the horizon, please arrange a meeting with Joe

Millar or Trish Mitcheson & we can complete this form together.

• Alternatively if it is not possible to meet, then you can complete the form

remotely and email to researchdevelopment@stees.nhs.uk for review. A copy

• f

the form is available

• n

the R&D intranet: http://stas16/intranet/services-a-z/academic/research-and- development/research-forms/

Approvals/Time Lines

• On receipt of the SSI, R&D have 15 days to carry out the governance

review NB: A new HRA approval process will be introduced in the future, which will reduce the requirements for ‘governance review’ at NHS Trusts. Further info at: http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment- approval/; R&D will communicate any updates.

• Clinical trials (CTIMPs, Medical Devices, RCTs and Other CTs) are

reported on every quarter as part of ‘PID’.

• The research team for clinical trials have 70 days to recruit their first

patient from the valid research application (i.e. SSI submission) – hence the importance of early discussion with R&D to pre-empt potential delays in randomising patients.

Additional Authorisations

• Authorisation from the Clinical Director or Chief of Service via their email
• account. CIs/PIs cannot sign off their own studies
• Studies which require ‘additional’ support from Pharmacy, Pathology or

Radiology require a hard, signed copy or electronic copy of the relevant Mutual Co-Operation Agreement (available on the R&D intranet). If electronic then require an email trail between PI/Research Nurse to the Support Service concerned to indicate that discussions have taken place.

• Studies which only require ‘routine’ support from Pharmacy, Pathology or

Radiology should be notified to the relevant contact (via email) for their

• awareness. A Mutual Co-Operation Agreement is not required.

Additional Internal Governance Requirements

• CTIMP studies - CV’s for PI and research team members
• CTIMP studies – GCP certificates for PI and research team members
• Non-CTIMP studies - CV’s for PI and research team members
• Non-CTIMP studies - GCP certificate for PI
• Declaration of Understanding (for new PIs or those who have updated

their GCP training

Hints & Tips

• Use the green information icons for each of the questions
• Do not amend forms/checklists once authorisations have been requested

as any amendments will invalidate the authorisations

• Do not submit forms until discussions have taken place with R&D
• Ensure timelines are realistic
• Complete the feasibility form prior to accepting the study or making a

study submission for approval

R&D Support R&D operate an open door policy. If you have any queries regarding the feasibility form or IRAS, in the first instance contact: Joe Millar Assistant R&D Manager

• r

Trish Mitcheson R&D Facilitator

ANY QUESTIONS