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This Question and Answer guide has been produced to support sponsors and CROs who are submitting applications into the Combined Ways of Working (CWoW) pilot and are therefore using the new part of IRAS. 

Contents

IRAS User Roles and Tasks

Can we use generic e-mail accounts for the Project Deputy so that different people in the organisation can pick up this role for the same application?

The new part of IRAS has the functionality to associate many individuals to a study via the ‘Collaborators’ function. This is to ensure better auditability and access control. An ‘Edit’ collaborator can update the study just as a Project Deputy (PD), however the PD or CI would need to make all actual submissions. While we cannot stop users sharing a generic email address for the PD role, we would advise against this.

We have already provided the Project Deputy details for a trial which has now been migrated, can I change who the Project Deputy is?

Yes, you can now change the Project Deputy (PD) directly from your IRAS account.

If the project is set-up with the PD named, the CI will only have read-only access for migrated studies. This PD can select a new PD from the drop down list (My tasks > My personal tasks > (select project) > Update key associates. As soon as this is done, the current PD will lose the access and the new PD becomes the PD who will automatically take over access and management of the project.

Can I change the Project Deputy for a trial which has been submitted for review by the regulators?

No, once the application has been submitted for review you cannot change the PD role. You will need to wait for the application to be approved and then you will be able to change the PD role.

Can the same e-mail account be used for the Project Deputy and the Sponsor Representative?

Yes, the same user can be named as the Project Deputy and the Sponsor representative.

Is the Chief Investigator (CI) still required to review the form? If so, will they log into the new system themselves and review it?

Yes, for new studies, CIs must sign in, and accept ownership of the study. For previously approved trials which have been migrated into the new part of the system, the CI won’t need to do anything.

Are the sponsors told they will get this request from IRAS asking them to accept sponsorship of the study?

Sponsor representatives will see the request under My tasks > My organisational tasks menu.

Screen shot from new IRAS module showing My Tasks, My Projects, My Personal Tasks and My Organisational Tasks

However, currently there is no e-mail notification to the sponsor representatives.

I have created an application and requested sponsorship which has been accepted. I now need to change the sponsor to be the CRO, how do I do this?

The CI/PD will be able to change the current sponsor by clicking on the ‘update key associates’ link. This can be done until the study is submitted by CI/PD.

Does the Chief Investigator need to accept the project in the new part of IRAS for trials which have been migrated?

Yes, the CI will need to log in; click on My Tasks > My Personal Tasks > Accept Ownership.

How can I change the sponsor representative?

Another person within the sponsor organisation can request to be approved as the sponsor representative. You need to do the following:

  • go to the top right hand corner of the screen and click on your name > profile section
  • click on the ‘Edit’ link against the Sponsor Office’ section in the middle of the screen
  • click on the ‘Add Organisation’ link and fill in the name of the CRO or sponsor organisation > save changes
  • a request will be sent to the sponsor organisation.

The sponsor organisation will then need to approve the request by doing the following:

  • click on ‘My Tasks > ‘My Organisational Tasks’
  • open the request in the ‘Organisation representation requests’ section
  • accept the request and click on the ‘Submit’ button.

NIHR Portfolio

How do we submit to the CRN to be adopted onto the NIHR Portfolio? 

If you require support from the NIHR Clinical Research Network (NIHR CRN) you will now need to contact your local Clinical Research Network (LCRN) to submit an application; there will not be an option to apply for NIHR CRN support in the IRAS development system.
You can find your local CRN here or visit NIHR Clinical Research website for more information. please visit. 
Alternatively, you can email the Study Support Service Helpdesk at supportmystudy@nihr.ac.uk or call 0113 343 4555 for further assistance.

We have submitted the PAF to the CRN NIHR using the original IRAS ID and now have a new IRAS ID which is different. What do we do?

If you e-mail cwow@hra.nhs.uk with the original IRAS ID and the new IRAS ID, we will inform the CRN. You will then need to contact the LCRN to arrange for the application to be submitted.

Submitting an Application

Can we submit an application into the Combined Ways of Working Pilot via the standard part of IRAS?

No. All applications which are submitted under the Combined Ways of Working pilot must be submitted via the new part of the system.

I have logged in, but I am unable to work on a particular project application, which is that?

This happens when someone else is working on the project as only one user can work on the project at any time.

We have included the IRAS ID from the main part of the system on our documents and now have a new IRAS ID from the new part of the system, what do we do?

The IRAS ID from the new part of the system is the IRAS ID which you need to use going forward and therefore this must be the ID which is included in supporting documents. You will therefore need to update the supporting documents to include the new IRAS before you upload the documents for submission.

I have submitted my application via the new part of IRAS and it had been validated. However, I have just realised that there is a document which I haven’t uploaded in error, can I submit the document via the system?

No, you will not be able to submit the document via the system until you receive a request for further information (RFI) after the application has been assessed by the REC and MHRA. However, you may provide the document by e-mail so that it can be considered as part of the assessment and then you will need to re-submit the document via the system as a response to an RFI (please note: if the document is essential for assessment purposes, the clock may be re-set to day 0 on receipt of the document).

The system says, ‘Pending Sponsor Review Status’, what does this mean?

This status indicates that the submission is successful up until this point and is pending verification of the application prior to submission. Once the application has been verified and submitted, you will see ‘Pending Regulator Decision’.

How do I delete a project?

Select the ‘Action’ button at the top right hand part of the screen and select > Delete Project.

Please note: This option is only available until the project has been submitted and will not be available after submission.

I have submitted a project application but now I need to make a change to it, can I do this?

No, it is not possible to make a change once a project application has been submitted. If you do need to make a change, you should contact cwow@hra.nhs.uk with details of the information to be changed. Consideration will be given to whether the application should be withdrawn or whether the further information can be accepted outside of the system (please note: if the information is essential for assessment purposes, the clock may be re-set to day 0 on receipt of the further information).

The information will then need to be formally updated in the system at a later point in the process as part of a ‘Request for Further Information’.

I have uploaded a document and now need to edit the document title, can I do this?

It is not possible to edit the document title, version number or date after the document has been uploaded. You will need to remove the document and re-upload with the corrected information.

Please note: This is only possible prior to the application being submitted. If you need to change this information after a project application has been submitted, you should remove the document and re-upload with the corrected information as part of a ‘Request for Further Information’. If this is necessary, please inform cwow@hra.nhs.uk.

Is there an option to transfer the study like currently happens with the standard IRAS?

The new part of IRAS works differently to the standard part of IRAS. Instead of transferring the project, everyone involved in the project can be given access in the system and therefore transferring is not necessary.

Do we have the option to download the “study information” as a pdf for TMF filing?

Yes, after the study is sent to the sponsor for submission, this document can be downloaded by going to ‘My projects’ and selecting the IRAS ID, then from Project history section, opening the ‘P-‘ link then going into Project documents section. The document can be found under ‘System generated documents’. Please note that this document will not be available for migrated studies.

We have an internal QC process which involves another person (who may be in a different location) checking that the correct documents have been uploaded, how do we do this in the new part of the system?

If anyone else other than the Chief Investigator/Project Deputy needs to verify the documents before submission, they can be added as Collaborators. They will then be able to see the documents which have been uploaded.


We have not completed and submitted the full standard IRAS form, what documents therefore need to be provided for the Local Information Pack?

The following template documents should be provided:

  • Recruitment and informed consent procedure
  • Ethical considerations form
  • Payment of compensation
  • Study wide review form

Which documents do I include in the Local Information Pack?

For information about which documents should be provided with the Local Information Pack, please refer to the guidance which is available on the standard IRAS site.

https://www.myresearchproject.org.uk/help/hlpsitespecific.aspx#UK-Local-Information-Pack

 Additionally, the CWoW template documents which are submitted with the CWoW application dossier (instead of the standard IRAS form) should be provided.


Responding to a Request for Further Information (RFI)

If it is not possible to respond to all of the points raised as a Request for Further Information (RFI) within the 14 days allowed, would the entire application be rejected or just rejected by the organisation which raised the point which could not be addressed within the timeframe?

If you are concerned that you will not be able to achieve the 14 day timeline to respond to any requests for further information, you should contact cwow@hra.nhs.uk and state when you think you will be able to respond by. An extension to the 14 days may be granted where this will not significantly impact on the overall 60-day timeline.

Where it is not possible to respond to all requests for further information in the timeframe, even where a request has been granted, the application will be rejected.

The REC and MHRA authorisation are independent reviews but under the Combined Ways of Working pilot, this is a co-ordinated review process which results in a single decision. What this therefore means is that if the trial is not approvable overall with both a positive REC and positive MHRA outcome then the overall application is rejected. However, proportionate arrangements will be in place for the resubmission of an application which was authorizable by either the REC or the MHRA.

When responding to an RFI, do I type the response in the text box or send the response in a covering letter?

You can either type your responses directly into the text box or you can copy the requests for further information from the text box into a separate document and provide your answers that way. However, please be aware that there is a character limit for the text boxes which we are working to increase, and we therefore recommend that full responses are provided in a cover letter until the character limit has been increased.

If you are providing your responses in a separate document, you just need to add a comment to the text box to confirm this.

Once you have added information to the text box you will need to select ‘Continue’ and then this will take you to the page where you can upload your documents. If you need to go back to the screen with the RFI text boxes, you will need to select ‘Update RFI details’.

Trial migration and substantial amendments

We are preparing a substantial amendment for submission, but we haven’t been notified that the trial is being migrated to the new part of the system, what do we do?

Contact catherine.blewett@hra.nhs.uk providing the IRAS ID, the sponsor (if you are a CRO this will be the name of the CRO), the name of the CI and a named project deputy (this could be the CI or someone who is undertaking tasks on behalf of the CI). When we have this information, we can check whether the trial can now be migrated. Once the trial has been migrated, you can then submit the substantial amendment via the system.

The system is requesting Substantial Amendment validation for a migrated study, what do I do?

The information which is migrated into the new part of the system can only be the information which is available at that point. However, when a project information substantial amendment is made, it will be necessary to complete the missing information before you can submit the amendment. You will be able to see what information needs to be completed by clicking ‘save and verify’.

Please note: If you are updating the study information ‘question set’ as part of a project information substantial amendment, you will need to ensure that you fill in all of the required information; otherwise the system will not allow the substantial amendment to be submitted.

If you do not need to update the study information ‘question set’, you will need to de-select the ‘study information’ checkbox on the first screen.

I am submitting a substantial amendment to change the Chief Investigator. How do I upload the CV for review?

The CV needs to be uploaded to the system by the Chief Investigator. The CI should log into the system, go to ‘My Tasks’ and then they should see the option to upload documents under ‘My Personal Tasks’.

My trial has been migrated to the new part of IRAS, which documents do I need to upload?

Uploading documents to the new part of IRAS has two purposes and these should be taken into consideration when you are uploading documents. Firstly, these will be documents which could be amended as part of a future substantial amendment and therefore any documents which may be amended should be uploaded. Secondly, as part of the future development work the intention is that appropriate documents can be accessed by sites directly via the system. Therefore, any documents which you would share with new sites should be uploaded. Only the most recent version of the documents should be uploaded.

·        The following is a list of documents which should be uploaded (please note this is not an exhaustive list of all documents which should be uploaded).

  •        Annex 1 form
  •        Annex 1 xml.
  •        Protocol
  •        Investigator’s Brochure
  •        IMPD (this is saved separately and would not be shared with sites)
  •        IMP Labelling documents
  •        GMP documents
  •        Information sheets
  •        Informed consent forms
  •        Advertising documents
  •        GP letters

I uploaded some but not all of the documents and moved the application to the authorised state, how do I now upload the other required documents?

The only option to add the missing documents after the trial has been moved to the authorised state is to submit them as a substantial amendment and submit the documents this way. There wouldn’t need to be an actual review of the documents as they are already approved, it would just be the only mechanism to open the ‘portal’ to submit the documents so they then show on the dashboard as the approved documents.

The cover letter should be clear that the substantial amendment submission is for the purposes of submitting the documents into the system and not for review.

If they are all MHRA only documents which are missing, then you will need to select MHRA and Part 1 when submitting the substantial amendment. However, if they are documents which are relevant to the REC also (e.g protocol or IB) then you should select both MHRA and REC and Part 1.

Final approvals

The date of the Favourable Opinion letter from the REC is different to the date it was recieved via the new part of IRAS, why is this? 

The REC favourable opinion is generated and issued in the system, but the letter will only be issued to the sponsor when the MHRA CTA is also ready to be issued so that both outcomes can be issued together. This means that it could be in the system for several days before being issued to the applicant and therefore the date of the letter will not necessarily be the date of issue. To ensure that this is clear for sites, we will add some text after the date to confirm that the date the letter is completed by the REC is not necessarily the same date that the letter was formally issued.  

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