CPMS Submission for Study Resource Review
If a submission is made for Study Resource Review without completion of the iCT, will the CRN complete the Study Resource Review for me?
No, this service can only be completed with provision of a completed costing in the iCT and the matching protocol attached. Failure to complete the iCT resource summary or to attach a matching protocol will result in the submission being reverted to you.
How is the Study Resource Review service added to an existing CPMS submission for commercial services?
Find the study in the ‘My commercial submissions’ tab on the left in CPMS, highlight the study with the radio button on the left and rather than click the blue button that says 'Create submission for a new study' click on the white button at the bottom of the page that says 'Add new submission to selected study'. You will then be able to add a new service to the previous CPMS entry.
After being assigned a role in the study record in CPMS, where do I find the iCT?
Depending on the role assigned to a user in the study record in CPMS, the iCT will appear in different menus:
- Company representative: Pre-submission it appears in the ‘My Commercial Submissions’ tab. Once validated it appears in the ‘Interactive Costing Tool’ tab
- Study Resource Reviewer: Pre- Study Resource Review the iCT appears in the ‘Commercial Study Submissions’ tab. After review it appears in the ‘Interactive Costing Tool’ tab.
Site Representative: Appears in the ‘Interactive Costing Tool’ tab.
If there are still issues in finding/accessing the iCT, please ensure CPMS is being accessed using Google Chrome as occasionally some functionality may be lost in other browsers.
Does completion of the iCT and Study Resource Review mean the study will be included on the NIHR CRN Portfolio?
Completion of the iCT and Study Resource Review does not mean the study has been accepted onto the NIHR CRN Portfolio. You must have completed at least one of the site services (Site Identification and/or Site Intelligence) before the study can be considered for inclusion on the NIHR CRN Portfolio and receive CRN support.
Can a draft costing in the iCT be submitted for Study Resource Review if a protocol is not yet final?
Yes, however we advise against submitting an iCT for Study Resource Review until a protocol as close to final as possible is available, to ensure swift and considered review. Early Feedback submissions with early draft protocols are encouraged but by the time Sponsors are ready to submit costings and are in the process of identifying sites, it is helpful to have as near final protocol as possible. You must submit for Study Resource Review in parallel with your submission for regulatory approval via IRAS.
Is there a demo version of the iCT available to practice?
No, there is not a demo version of the iCT. However, there are a collection of videos tutorials linked to in the ‘Guidance and supporting information’ section of the iCT Getting Started page on the NIHR website that show you what the system looks like and how to go about creating a Study Resource Review submission.
Why is the following error message being received when trying to submit the iCT: ‘* There must be at least one Activity occurring on a Visit for Arm: XXX’?
This error appears when there is a row or column somewhere that totals zero/is missing a value. Please check the column on the right hand side of the iCT to check that there is a value for every activity. Where there is a value missing and there are not any visit occurrences entered, please enter the appropriate, scheduled visit occurrences. If the visit occurrence is unknown, then please move this activity to the unscheduled section.
If there are not any values missing in the right hand column, please check the bottom row to see if there are any missing values for a particular visit. Select the correct activities to take place on that visit or remove the visit if there are not any activities occurring.
Once visit occurrences are entered, you will be able to submit the iCT for review. Please note, downloading the iCT into Excel can make it easier to view the iCT and help highlight any missing values.
How long does it take for the iCT to be reviewed?
Timelines for a Study Resource Review are aligned as close as possible to the Health Research Authority (HRA)’s Initial Assessment timelines. We aim to complete reviews within 30 days from assignment to a Study Resource Reviewer.
Can access to the iCT be assigned to additional individuals or to a central login rather than an identified staff member in case individuals are on leave/out of the office?
Additional individuals can be added to the study record in CPMS which will provide access to the iCT for that study. To add additional Company Representatives/Study Resource Reviewers, please contact the Study Support Helpdesk (firstname.lastname@example.org) and ask them to signpost your enquiry to the Industry Team who will assign the correct role within the study record in CPMS. Company Representatives can add additional Site Representatives themselves. Please see ‘How are sites given access to the iCT?’ FAQ for method.
CPMS also accepts group email addresses so if a Sponsor/reviewer/site has a group email address that they wish to set up a CPMS account for, then that email address can be assigned the relevant role in the study record to allow access. Please note, a CPMS account needs to have been created and activated (by logging in) for this email address prior to being assigned a role. See getting started and logging into CPMS for more information.
Do the HRA require confirmation of iCT completion and submission for Study Resource Review for IRAS submissions for HRA approval?
Yes, this can be evidenced by uploading the CPMS “Submission status : In progress” email to your submission. You do not need costs to be agreed in order to progress with IRAS submissions. The Study Resource Review and HRA Initial Assessment will happen in parallel.
Within the IRAS submission itself, there is a document checklist section which provides information about what the minimum requirement is. Additional guidance can be found in IRAS Help - Templates for supporting documents and on the HRA website - Prepare study documentation.
If further guidance is required, please contact the HRA/IRAS support for clarification:
When looking at the iCT in CPMS it does not look like the version shown in the video tutorials; there are buttons missing and the rows do not match up. Why is this?
Please ensure CPMS is being accessed using Google Chrome as occasionally some functionality may be lost in other browsers.
It seems a comment is required when adding some activities but not others in the iCT. Why is this?
A comment is only required before submission if an activity is selected from a search and then the auto-populated reference data (unit cost or staff role/time) is altered. This will help the reviewer to spot any changes from the ‘standard tariff' without having to compare each activity against a separate tariff document. Guidance on this is available in this video tutorial (5m4s - 5m39s).
How are version controls of the iCT managed?
The tool has no version control; it is a live system so users will always see the most up to date version. In response to feedback from users, the ability to mark a site costing as ‘Complete’ to indicate that the review of the site costs has been completed was introduced on 8th December 2021. For further details, please see the Site iCT Status Change document.
When should the Scheduled Activities ‘Some Participants’ section in the iCT be used instead of Unscheduled Activities ‘Additional Itemised’ section?
If an investigation/procedure has a schedule but would not occur for all participants, e.g. a scheduled pregnancy test prior to dosing in a CTIMP. Guidance on this is available in this video tutorial (9m37s - 10m44s).
Is there a way to change details after submitting for Study Resource Review? E.g. go back and attach the protocol?
As is the case with other CRN service submissions, you can contact the Study Support Helpdesk (email@example.com) and ask them to signpost your enquiry to the Industry Team who will 'revert' the submission so it can be updated and resubmitted.
Is the iCT tariff data (previously rate card) available to check which procedures and investigations are included as a standard cost and which will need to be a manual entry in the iCT?
Yes, the most recent iCT tariff data document is available in the ‘iCT tariff data’ section of the iCT Getting Started page on the NIHR website for easy reference.
How can activities that are not found when searching in the iCT be entered into the costing?
Any investigations/procedures that are not included in the iCT can be entered manually. You do not need a specific code to do this. Guidance on how to do this is available in this video tutorial (7m30s - 8m10s).
Should there be a study ‘Setup & Closedown’ arm for each of the sites on the iCT?
Yes. Previously, Setup & Closedown costs were only available to be inserted at a site level in the iCT (i.e. after the Study Resource Review service was completed) and guidance on how to do this is available in this video tutorial (3m13s - 5m40s). From 11 March 2020, Company Representatives have been able to add generic Setup & Closedown activities to the iCT right from the start of their submission for Study Resource Review. A tab is available within the ‘Interactive Costing Tool’ page of the submissions window titled 'Setup & Closedown' to capture this information separately to the per participant budget.
Can the iCT be used to create a costing without submitting for Study Resource Review?
Yes, companies can use the iCT to ‘draft’ a costing but please do not submit until the full study record is complete. Please be aware that iCT will provide generic study costings (per participant cost and Setup & Closedown) but it will not include the additional costs required to start and deliver a study at a particular site (indirect costs, capacity building and MarketForces Factor) until the costing has been submitted, reviewed and released to sites.
Is there a way to see respective overheads and Market Forces Factor (MFF) before submitting the iCT for Study Resource Review?
No, indirect costs, capacity building and MFF values are not visible in the iCT until the costing has been submitted, reviewed and released to sites. However, there are lists of the MFF costs for England available if you wish to calculate these yourself - they can be found in the ‘Guidance and supporting information’ section of the iCT Getting Started page on the NIHR website.
MFF did not apply to certain setup costs in the previous Excel costing template, e.g. participant travel costs and refreshments. However, in the iCT MFF is applied, is this correct?
MFF is automatically added to these activities by the tool but these costs are not mandatory. Travel, refreshments and financial reimbursement for volunteers can be added directly to contracts and these activities do not have to be captured in the tool. These activities are classified as 'local contractual arrangements'.
Where are pharmacy fees for the study added into the iCT?
Pharmacy per participant fees (dispensing, accountability, returns etc) are available in the per participant budget in the iCT along with all the other per participant activities - please add all per participant activities here. The pharmacy setup, maintenance and closedown costs are available in the ‘Setup & Closedown’ arm - please add these costs here as appropriate.
Why has the Chief Investigator fee been removed from the iCT tariff data?
The Study Resource Review and the iCT facilitates consistent agreement on the resources required to deliver a study at any participating NHS site. It is not possible to include site specific costs such as Chief Investigator fees in a national level review.
There have also been an increase in the number of non-recruiting institutions becoming Chief Investigators for commercial studies.
It should also be remembered that CI contracts and consultancy agreements are routine in the academic sector.
For reference, the description of the previous Chief Investigator fee was as follows:
The Chief Investigator has additional tasks covered by this fee which are associated with:
- Ethics and MHRA review of documents
- Ethics submission
- Ethics meeting attendance
- Liaison with ethics assessment team
- Attendance at safety meetings throughout study
- Submission of Annual Progress Reports/ Development Safety Update Reports
- Provision of general medical oversight throughout the study including key teleconferences, Trial management, steering committee meetings to lead on study issues.
- Administration support time for activities listed above.
If Chief Investigator involvement is only signature of Ethics form, this fee is not chargeable
Further activities, especially prior to site selection, should be considered as a separate consultancy service which is not covered in this fee. A separate consultancy contract/costing is recommended.”
Do Excel costing templates need to be converted into the iCT?
No, not if the previous costing template was validated.
Does a protocol amendment that impacts a study costing need to be redrafted into the iCT for a study where the costing was originally submitted using the previous Excel costing template?
No, not if the previous costing template was validated. Previously validated Excel costings are still valid and should still be used. If an Excel template has previously been validated then it does not need to be resubmitted via the iCT or need to be validated again if there has been an amendment - please amend the original costing template and send this back to the sites. If, however, the original Excel costing template was not validated, then a new Study Resource Review submission using the iCT is required.
Should the iCT be used to add additional sites to older studies that used the previous Excel costing template?
No, the iCT does not need to be used to add new sites to a study. As long as the original Excel costing template was validated, it will still be valid for use. New sites can be added by request to your Lead LCRN. Any submissions made after 1st April 2020 need to utilise the iCT to create their costing.
Study Resource Review
When individuals are given access to a study in CPMS, is there an alert that is sent out to notify the relevant parties of this? Are there other email alerts too, e.g. to inform that the iCT has been edited or approved etc?
CPMS itself does not create 'alerts' but generally once an access request is actioned an email will be sent to acknowledge this. However, there is no standard practice for this to be done and this may not happen in every instance. If you have not received confirmation of completion of your access request, we advise you to check to see if your request has been actioned and to follow up if not. We expect that communications between Company Representatives, Study Resource Reviewers and Site Representatives are maintained in much the same way as with the previous Excel costing template, e.g. phone calls and emails to update each party when changes are made and require review.
Can the Devolved Administrations (Scotland, and Wales and Northern Ireland) use the iCT?
Yes, Scotland, Wales and Northern Ireland are using the iCT and the National Contract Value Review is a UK-wide programme, meaning reviews are accepted by organisations across borders.
When comments are made in the iCT at the review stage or by the site, should these be dealt with inside the CPMS system?
Yes, comments made can be reviewed and accepted/rejected/amended inside the iCT by the Company Representative, Study Resource Reviewer and Site Representatives. This video tutorial explains the process. Of course, the iCT is not a replacement for other communication channels so if clarification as to why somebody has said something or made a specific change is required, then we suggest contacting the relevant party directly to have that conversation outside of the iCT. Ultimately, it is expected that any changes between the data in the iCT and the data in the signed agreement are in writing somewhere (in short, it is probably easiest to have these changes maintained in the iCT).
Can an NHS Costing Expert review iCTs for studies which are not yet on the NIHR CRN Portfolio?
Yes. All submissions made for Study Resource Review in CPMS are assigned to a Study Resource Reviewer.
Amendment/Update Post Study Resource Review Completion
Do all comments in the iCT have to be resolved?
It is best practice to resolve all comments, particularly before releasing costings to sites, as any unresolved comments in the study level costing will be copied into each site costing and therefore duplicated. In response to feedback from users, the ability for Company Representatives to preview site costs before releasing to Site Representatives and to delete a site costing at any stage of the review process was introduced on 8 December 2021. This provides the ability to ‘re-release’ a site costing (by deleting and creating again) if comments were duplicated and the Company Representative wishes to resolve them in the study level costing before proceeding to creating and releasing site costings. For further details, please see the Site iCT Status Change document.
If there are comments that a user needs to respond to in the iCT, they will be marked with an orange flag. If there are comments made by the user that are awaiting response, then the flag will appear grey to the user, to show these comments require response by one of the other parties. This video tutorial explains the process.
Is there a way to resolve multiple comments at the same time in the iCT?
Yes. In response to feedback from users, the ability for a user to add new visits/activities and their associated occurrences/activity counts with only one comment has been introduced, which in turn allows users to view and accept grouped comments with one click. This functionality reduces the number of clicks and saves users time completing or reviewing the iCT.
How should protocol amendments that impact a study costing be reflected in the iCT?
If the iCT has been reviewed by an NHS Costing Expert, it does not need to be reviewed again if there has been an amendment - please make any necessary amendments directly within the existing iCT for the study in CPMS and share these with the sites.
Previously, if a Company Representative has already released the costings to the sites, amendments had to be made in each of the individual sitecostings as amendments in the study wide costing could not feed through to each site costing. In response to feedback from users, the ability for Company Representatives to preview and edit site costs before releasing to Site Representatives and to delete a site costing at any stage of the review process was introduced on 8th December 2021. This provides the ability to ‘re-release’ a site costing (by deleting and creating again) when an amendment is made in a study level iCT so that these changes will also be reflected in the site costings. Rather than having to update each site costing with the same amendment individually. For further details, please see the Site iCT Status Change document.
Please be aware that deleting and recreating a site costing will overwrite and interfere with any accepted changes/ongoing negotiations at a site level.
If the iCT has not yet been reviewed, please contact the Study Support Helpdesk (firstname.lastname@example.org) and ask them to signpost your enquiry to the Industry Team who will 'revert' the submission so it can be updated and resubmitted.
When an amendment is made in a study level iCT that has been reviewed, will these changes also be reflected in each site’s costing or does each site’s costing have to be updated with the same amendment individually?
Previously, if the Company Representative had already released the costings to the sites, amendments had to be made in each of the individual site costings as amendments made in the study wide costing could not feed through to each site costing. In response to feedback from users, the ability for Company Representatives to preview and edit site costs before releasing to Site Representatives and to delete a site costing at any stage of the review process was introduced on 8th December 2021. This provides the ability to ‘re-release’ a site costing (by deleting and creating again) when an amendment is made in a study level iCT so that these changes will also be reflected in the site costings. Rather than having to update each site costing with the same amendment individually. For further details, please see the Site iCT Status Change document.
Please be aware that deleting and recreating a site costing will overwrite and interfere with any accepted changes/ongoing negotiations at a site level.
If the Company Representative is yet to release the costings to the sites, then amendments made within the study level iCT will feed through to each site costing once the costing is released.
A second CPMS submission with a new CPMS ID has been created with a new costing accidentally. Can these two study records be merged?
No, if a duplicate study record is created in CPMS, this will need to be removed. Please contact the Study Support Helpdesk (email@example.com) and ask them to signpost this enquiry to the Industry Team who will delete the duplicate study record.
Following this, if the Study Resource Review service was not requested during the original submission for the study, this service will need to be added to the existing submission. Please see ‘How is the Study Resource Review service added to an existing CPMS submission for feasibility services’ FAQ for method. If there is already a Study Resource Review submission for the study, then any necessary amendments can be made directly within the existing iCT for the study in CPMS. Please see ‘How should protocol amendments that impact a study costing be reflected in the iCT?’ FAQ for method.
Submission to Site(s) for Site Review
The Study Resource Review is complete. Do sites automatically contact the Company Representative with a contract proposal including resource estimations?
No. Once the iCT has been reviewed by a Study Resource Reviewer, the Company Representative needs to review and accept/respond to any comments made (marked by an orange flag). Following this, once sites are present in the study record in CPMS, the Company Representative will need to assign Site Representatives to the iCT and release the costings to these sites so the Site Representatives are able to view them. Please see ‘How are sites given access to the iCT?’ FAQ for method.
Study costs will vary from site to site depending upon the institution’s Market Forces Factor (MFF).
The Study Resource Review is complete and the iCT has been reviewed but there are not any sites present in the iCT to allow access to site costings. How are sites added to the study record in CPMS?
Sites can be populated into the study record in CPMS in the following ways:
- Site ID service or Site Intelligence Service:
- In order for a study to be included on the NIHR CRN Portfolio and receive support, the Company Representative will need to submit for one or both of these services. Once complete, all sites will automatically be populated into CPMS
- By completing Part CoftheIRAS submission or Section G of the Medicines Information question set in the combined review application:
- If all sites are listed in the application, they will be populated into CPMS. This will occur once the site is formally invited to take part in the study which is when the contract is sent to the relevant R&D office and they log the study in the system
- Request sites are added by the Lead Network
- A request can be made to the Lead LCRN to add these sites. This is the LCRN where the Chief Investigator is based
Once the sites are present in the study record in CPMS, they will appear in the iCT for the study. Click the blue ‘Create’ button to the right hand of the Parent Organisation. After this, the Company Representatives can select ‘View and Edit’ in the Site Costs column to preview the site costing and choose whether they want to carry on with a site review and make any site specific amendments required. Once happy to proceed, the Company Representative selects the ‘Release to Site’ button in the Action column to give Site Representatives access to the site costing.
For LCRNs, page 6-14 explains how sites can be added to the study record:
How are sites given access to the iCT?
Once sites are present in the study record in CPMS and the iCT has been reviewed, Company Representatives can assign the iCT to their sites in CPMS (and therefore add the respective indirect costs, capacity building and MFF values). To do this, the Company Representative needs to:
- Add Site Representatives - Access the iCT menu in CPMS and find and click on the study. Find the ‘Site Representatives’ heading below the iCT arms. Enter the site contact email (the email that the Site Representative uses to login to CPMS) in the Site Representatives field and click the white ‘Add Site Representative’ button. Please note, the Site Representative needs to have created and activated (by logging in) an account in CPMS first
- Activate the relevant site costings - Find the ‘Study Organisations’ heading further down on this screen, with all the site names listed below. Next to each Parent Organisation is a blue 'Create' button in the action column, click this to generate a site costing. After this, the Company Representatives can select ‘View and Edit’ in the Site Costs column to preview the site costing. Once happy to proceed, the Company Representative selects the ‘Release to Site’ button in the Action column to give Site Representatives access to the site costing. The site will not see anything in CPMS before the costing is released to the site by the Company Representative. This 'safety catch' was included within CPMS to stop all site costings going live for all CPMS sites automatically, i.e. the Sponsor or CRO can choose which sites they want to negotiate costs with and in which order to do so.
Previously, as soon as the site costings were accessed they would ‘go live’ and be released so that the sites could see them too. In response to feedback from users, the ability for Company Representatives to preview and edit site costs before releasing to Site Representatives was introduced on 8th December 2021. For further details, please see the Site iCT Status Change document.
Can all Site Representatives view all the other site costings in the iCT?
Yes, this has been done to enable transparent review by sites and to assist should one site require another institution to help with its costing.
How do Site Representatives access site costings for studies they are assigned to?
Please login to CPMS using the email address that has been assigned the role of Site Representative. Access the Interactive Costing Tool tab on the left in CPMS, find the correct study and click on the ‘View Details’ button on the right. Scroll down to the ‘Study Organisations’ heading and find the relevant site name, click on the 'View and Edit' button in the Site Costs column on the right to access the individual site costing. Here, the study arms and Setup & Closedown arm will be visible. Click into each arm to review/edit the activities and any comments.
Some Study Resource Reviewers are opting to export the data into Excel and make changes there, and then asking the Company Representative to update the iCT. How can it be ensured that all relevant parties follow the correct process?
Reviewers need to update the iCT themselves as any changes they make will need to be clearly shown 'in system' providing a direct audit trail. This protects the Sponsor in negotiation and shows that the Company Representative has only accepted what they feel is justified, and it protects the site by showing the real resource required to run the study.
How are site negotiations managed for sites that ask for revisions to the iCT post Study Resource Review?
Under Stage 2 of National Contract Value Review, no site level revisions to an iCT which has had a Study Resource Review conducted by an NHS costing expert are permitted in the system. This is with the exception of Phase I, IIa and ATMP studies. General Practices can voluntarily commit to adhering to the costs generated by the iCT. A list of General Practices who have committed to this position is available in the Tariff Workbook.
Can private sites on a study use the iCT?
The iCT does not support private sites as NHS overhead values and regional MFFs do not apply. Private sites are free to fully negotiate pricing outside of the NHS guidance and systems.
Export to Excel/Word
Should there be somewhere to indicate final and agreed costs in the iCT?
The iCT has been designed as an open end process to allow flexible negotiation of the final contract and the addition of post contractual amendments. Previously, it had no defined end point, other than the word Financial Appendix export.
In response to feedback from users, the ability to mark a site costing as ‘Complete’ to indicate that the review of the site costs has been completed and the ability to change the status of a ‘Complete’ site costing to allow it to be amended was introduced on 8th December 2021. For further details, please see the Site iCT Status Change document.
Regardless of this additional functionality within the tool, the overall endpoint of the cost negotiation process is, in reality, the signature on the final mCTA and is therefore outside the provision of iCT.
Why won’t the Excel export download?
If the first 30 characters of any of the arm names in the iCT are the same, the Excel download can’t be generated. This is because Excel sheet names have a character limit of 30 and must be unique. Arm names can be edited by clicking on the arm titles within the iCT.