PSP100: NIHR RDN Portfolio Terms and Conditions Compliance Standard Operating Procedure 

All commercial and non-commercial studies included on the NIHR Research Delivery Network (RDN) Portfolio must comply with the Portfolio Terms and Conditions (T&Cs) in order to remain on the Portfolio and receive NIHR RDN support. Further information on RDN support offered for studies on the RDN Portfolio can be found on the RDN Portfolio webpage.

The Portfolio T&Cs apply from the point of the eligibility decision until the study closes to recruitment.

This document outlines how compliance with the T&Cs will be monitored and the process for managing studies in not in compliance with the T&Cs.

RDN staff both in the Coordinating Centre (CC) and the Regional Research Delivery Networks (RRDNs) have a role in providing support and help with ongoing engagement with the sponsor throughout the study lifecycle. The RDN are responsible for having processes in place to ensure that regular touchpoints are established to engage and remind the sponsors of their obligations to comply with the terms and conditions. These regular touch points will be set out in the data entry and data integrity process. RDN staff are expected to follow the data entry and data integrity process as business as usual activity.

This Standard Operating Process (SOP) will provide guidance for identifying studies and sponsors that have not engaged with the T&Cs of Portfolio inclusion. This SOP will lay out the process for sponsors not in compliance with the Terms and Conditions. 

The data items in Table 1 require ongoing maintenance by the sponsor (or sponsor delegate). The data items will be monitored from the date of eligibility confirmation (by email) until the study closes to recruitment to ensure compliance with the T&Cs.

Where sponsors or delegates do not provide updated data points within the timelines specified in the T&Cs, the study will be at risk of being withdrawn from the NIHR RDN Portfolio. The expected responses for each of the categories is listed below.

If an updated data point entry is not provided within the required timeframes, the study will be withdrawn from the NIHR RDN Portfolio. The process of withdrawal is explained below. An updated data point (i.e. new planned opening/closure date, updated target of updated study status) must be provided by the Sponsor or delegate. It is not sufficient for the sponsor (or delegate) to acknowledge receipt of the request without providing updated data.

1. Sponsors that have not provided data required for study record initialisation (including contact details) within 30 days of the eligibility decision (Please note this category of studies will be picked up centrally by the RDNCC team as part of the study record initialisation process and the dame warning emails from the template will be used)

2. In set-up studies that have passed the planned opening date and not provided a revised date within 90 days

3. Open studies that have passed the planned closure date and not provided a revised date within 90 days

4. Suspended studies that have not provided a planned reopening date within 90 days

5. Sponsors that have not submitted an assessment via the sponsor engagement tool within 90 days of the due date

6. Non commercial studies that have met target but have not provided a new revised target within 90 days

7. Commercial studies that have met target but have not provided a new revised target within 90 days

8. Studies that have not recruited for more than 6 months and have not provided RDN with details of reasons/mitigation plans

9. Studies that have not recruited for more than twelve months and have not provided RDN with details of reasons/mitigation plans

The studies that fall within one or more of the above categories will be identified on a quarterly basis following every quarterly data cut.

Once the list of studies has been identified, warning letters will be issued as per the process below for studies that are not in compliance with the terms and conditions.

Data entry and integrity will be performed in line with NIHR RDN SOPs. All key data points will be updated in CPMS by RDN staff on an ongoing, regular basis using information provided by the sponsor and/or their delegates.

Identification of studies not in compliance with the T&Cs will be performed on a quarterly basis.

Following every quarterly data cut, a list of non-compliant studies is generated in the T&Cs Compliance Open Data Platform (ODP) Qliksense Dashboard. The dashboard presents a 'fixed' list of studies which will form the basis for the compliance process at that quarter. Once the quarterly study compliance list has been generated, new studies will not be added to the list. However, the Dashboard includes live data updates in relation to studies included in the list (e.g. if a study is indicated as non-compliant due to being  >90 day past planned closure, if a new planned closure date is updated in CPMS, this will be reflected in the dashboard following overnight refresh).

Letter 1

Once non-compliant studies have been identified, the sponsor contact will be notified via the issue of a warning letter (Appendix A). The letter will be attached to an email and sent by the Lead RRDN. The Chief Investigator (CI) CTU/CRO, primary funder (where available) and study contact (as appropriate) will be copied in and sent using the RRDN SPOC email address.

This email will be initiated within 5-10 working days of the quarterly compliance list being  generated.

Once a letter has been issued, the Lead RRDN must update the Qliksense dashboard to record the date the letter was sent. This step must be undertaken to support tracking and reporting of the process.

The sponsor must respond with the requested information within 10 working days from the date of the initial email (refer to table 1). The Lead RRDN may choose to either address the studies with the sponsors collectively or individually as deemed appropriate. 

Following the ten working days, if the required data item has been provided, the study will fall out of this process and will be managed by the business as usual (BAU) data entry and data integrity processes.

Letter 2

If a satisfactory response has not been received (see table 1) following the first warning, a second warning letter will be issued and the Sponsor given further 10 working days to respond. The email will be sent from the RRDN SPOC email address and the CI, CTU/CRO, primary funder (where available) and study contact (as appropriate) will be copied in.

Once a letter has been issued the Lead RRDN must update the Qliksense dashboard to record the date the letter was sent. This step must be undertaken to support tracking and reporting of the process.

Sponsors that have engaged and provided a satisfactory response (see table 1) following the second warning letter will fall out of this process and will be  managed by BAU process.

Withdrawal

Where the Sponsor has not engaged and/or provided a satisfactory response following two warning letters this will result in the study being removed from the NIHR RDN Portfolio. Prior to withdrawal, the Lead RRDN will complete the T&Cs Compliance Checklist (Appendix D). Once this has been completed the final withdrawal letter will be sent. This letter will be sent by the Lead RRDN using the approved DHSC template.

The letter will explain the consequences of removal from the NIHR RDN Portfolio. This will include information about termination of any further RDN support to deliver the study and excess treatment costs. The Lead RRDN will also notify all participating RRDNs involved in supporting the delivery of the study and this information should be cascaded to participating sites. CPMS will be updated once the withdrawal email has been sent using the process listed below and a note will be added in CPMS to record the date of removal along with details.

Once a letter has been issued the Lead RRDN must update the Qliksense dashboard to record the date the letter was sent. This step must be undertaken to support tracking and reporting of the process.

Once a withdrawal letter has been sent, CPMS must be updated in order to remove the study from the active Portfolio:

3.4.1 CPMS is updated by the Lead RRDN as follows:

• The field 'Is Network Support Withdrawn?' is updated to 'Yes' and the date the withdrawal letter was sent entered as the date of withdrawal.

• The field can be found on the identifiers and Status tab in the CPMS study record and is editable by National Portfolio managers and Local Portfolio Managers based in the Lead RRDN.

• The field will only be completed for studies withdrawn from the Portfolio. It will remain blank for all other studies.

• Completion of this field will result in studies being removed from the active portfolio, excluded from reporting and no longer being able to access any NIHR RDN support or services (including the payment of support costs and ETCs).

• A Study note (note type: 'DHSC Letters') must also be added to the CPMS record to document all steps which have been undertaken by the RDN to support the Sponsor to provide the relevant data items, including the dates withdrawal letters were issued, prior to the portfolio withdrawal.

Removal from the NIHR RDN Portfolio is final. There is no route for appeal or re-inclusion of the study on the Portfolio

All study related activities which support the delivery of studies should be stopped as soon as the withdrawal letter has been sent. The letter should be copied to the Chief Investigator and study team. Participating RRDNs should also be notified by the Lead RRDN (Appendix G) to ensure participating sites can be informed, along with any other stakeholders as deemed appropriate by the Lead RRDN.

5.1 Appendix A: Initial warning letter template

Letter must be sent in PDF format.

Text of the letter is approved by DHSC and must not be amended other than to add study details, RRDN contact details and the reason for the warning.

Letter should be attached to an email and is sent on behalf of DHSC.

Suggested email text, (may be amended as required)

To: Sponsor

CC: CI, Study team, CTU

Subject: IMPORTANT: Notification of Warning Before Withdrawal from NIHR RDN Portfolio (CPMS ID xx)

Dear Sponsor

Re: CPMS ID: xx

Study Title: xx

Please find attached a letter sent on behalf of the Department of Health and Social Care (DHSC) in relation to the above named study.

According to data held by NIHR RDN, the study is more than 90 days passed the planned opening date/passed planned closure date/passed planned reopening date and is suspended/has met or exceeded the target held on our records/is due a sponsor assessment in the Sponsor Engagement Tool. Sponsors and their delegates are required to ensure NIHR RDN are provided with updated key milestone data in line with the Portfolio Terms and Conditions.

As per the attached letter, please provide an update on the current status of the study and updated data either by accessing the Sponsor Engagement Tool or by contacting us directly by no later than [date].

Please do not hesitate to contact us if you have any queries or need any support with this request.

Best wishes 

5.2 Appendix B: Second warning letter template

Letter must be sent in PDF format.

Text of the letter is approved by DHSC and must not be amended other than to add study details, RRDN contact details and the reason for the warning.

Letter should be attached to an email and is sent on behalf of DHSC.

Suggested email text, (may be amended as required)

To: Sponsor

CC: CI, Study team, CTU

Subject: IMPORTANT: Notification of Second Warning Before Withdrawal from NIHR RDN Portfolio (CPMS ID xx)

Dear Sponsor

Re: CPMS ID: xx

Study Title: xx

Further to our email on [date], please find attached a letter sent on behalf of the Department of Health and Social Care (DHSC) in relation to the above named study.

According to data held by NIHR RDN, the study is more than 90 days passed the planned opening date/passed planned closure date/passed planned reopening date and is suspended/has met or exceeded the target held on our records/is due a sponsor assessment in the Sponsor Engagement Tool. Sponsors and their delegates are required to ensure NIHR RDN are provided with updated key milestone data in line with the Portfolio Terms and Conditions.

As per the attached letter, please provide an update on the current status of the study and updated data either by accessing the Sponsor Engagement Tool or by contacting us directly by no later than [date].

Please do not hesitate to contact us if you have any queries or need any support with this request.

Best wishes 

5.3 Appendix C: Final Withdrawal letter template

Letter must be sent in PDF format.

Text of the letter is approved by DHSC and must not be amended other than to add study details, RRDN contact details and the reason for the warning.

Letter should be attached to an email and is sent on behalf of DHSC.

Suggested email text, (may be amended as required)

To: Sponsor

CC: CI, Study team, CTU

Subject: IMPORTANT: Notification of Withdrawal from NIHR RDN Portfolio (CPMS ID xx)

Dear Sponsor

Re: CPMS ID: xx

Study Title: xx

Further to our previous emails of [date] and [date], please find attached a letter sent on behalf of the Department of Health and Social Care (DHSC) in relation to the above named study.

According to data held by NIHR RDN, the study is more than 90 days passed the planned opening date/passed planned closure date/passed planned reopening date and is suspended/has met or exceeded the target held on our records/is due a sponsor assessment in the Sponsor Engagement Tool. Sponsors and their delegates are required to ensure NIHR RDN are provided with updated key milestone data in line with the Portfolio Terms and Conditions.

As per the attached letter, please note that the above study has now been removed from the NIHR RDN Portfolio and is no longer eligible for NIHR RDN support.

Please do not hesitate to contact us if you have any queries about Portfolio withdrawal.

Best wishes

5.4 Appendix D: checklist for Lead RDN before final withdrawal letter

• All contact points with dates and times recorded in CPMS

• All studies that are due to be issued with the withdrawal letter have received at least two warnings in addition to the regular touchpoints as per the data entry and data integrity SOP

• Sponsor engagement tool to be checked to see if any key information is being provided for the study to be removed from this list

• All emails/audit trails and CPMS notes checked to ensure that there is no recent contact from the sponsor with information about key study milestones.

What does withdrawal of NIHR RDN support entail?

Withdrawal of NIHR RDN support means that all NIHR RDN resources and services which are being used to support the study, at all study sites, will no longer be available. Adequate time and notification will be given to all parties to provide the necessary information and engage with the NIHR RDN before action is taken.

What does removal from the NIHR RDN Portfolio mean?

The study will no longer be included in the active NIHR RDN Portfolio, meaning the study will no longer be eligible for any NIHR RDN support or services, including support costs, and Excess Treatment Costs for studies where these are provided by integrated care boards (ICBs).

Where would sponsors or delegate organisations find their NIHR RDN point of contact?

For sponsors of no-commercial studies, your contact will be your Lead RRDN. For commercial sponsors, if their contact is not already known by the sponsor they can email the NIHR RDN Coordinating Centre (CC) team (rdncc.support@nihr.ac.uk) and a member of the team will assist.

How do I update information and data points in study records on the Central Portfolio Management System (CPMS)?

CPMS is used by the NIHR RDN to support study management from set-up to completion. Recruitment activity uploaded to CPMS, and other study data stored in CPMS, are used to support performance management of studies so that Portfolio studies achieve recruitment and time targets. Study teams,  company representatives, RDN and RRDN staff have different levels of access to the system relevant to their role. Sponsors (or their delegates) of non-commercial studies, should contact their Lead RRDN to support updates to key data points. For commercial sponsors, if the NIHR RDN contact is not already by the sponsor, they should email the CC team (rdncc.support@nihr.ac.uk) for assistance in updating any relevant data points.

Find out more via Updating key data points and information in study records on CPMS

What does NIHR RDN support include?

We offer a range of support to help you plan, place and perform high quality research.

If your study meets the eligibility criteria for the NIHR Research Delivery Network Portfolio, also known as the NIHR RDN Portfolio - we will work with you, research and development offices, funders, and other stakeholders to delivery your study to time and target.

Find out more about how we can help you plan, place and perform your study or trial in health or care settings.

7.7.1 Email 1: Lead RDN notifies participating RRDNs

To: Participating RRDNs (suggest this should go to their SPOCs)

CC:

BCC: Lead RDN SPOC (to retain a copy of the email in the inbox)

Subject: IMPORTANT: Notice of Study Withdrawal from NIHR RDN Portfolio (CPMS ID XX)

Dear Participating RRDN(s)

Re: CPMS ID XX

Study Title: XX

Specialty: 

CI:

Sponsor:

Sponsor Email Address:

List of Sites:

This email is to notify you that the above named study has been issued with a Final Withdrawal Letter sent on behalf of the Department of Health and Social Care (DHSC) on (DATE).

As per Portfolio Terms and Conditions, the above study has now been removed from the NIHR RDN Portfolio and is no longer eligible for NIHR RDN support. Please can you inform participating sites in your region about this change in status for the study.

If you have any queries please do not hesitate to contact RRDN XXX.

Best wishes

7.7.2 Email 2: Participating RRDN notifies participating sites in their region 

To: Participating RRDNs (via R&D/I SPOC)

CC:

BCC: Lead RDN SPOC (to retain a copy of the email in the inbox)

Subject: IMPORTANT: Notice of Study Withdrawal from NIHR RDN Portfolio (CPMS ID XX)

Dear Participating site

Re: CPMS ID XX

Study Title: XX

This email is to notify you that the above named study has been issued with a Final Withdrawal Letter sent on behalf of the Department of Health and Social Care (DHSC) on (DATE).

As per Portfolio Terms and Conditions, the above study has now been removed from the NIHR RDN Portfolio and is no longer eligible for NIHR RDN support or excess treatment costs from the NIHR. Please inform your Principal Investigator and/or local study teams of this notification.

If you have any queries please do not hesitate to contact the study Sponsor (insert email address) or us (SPOC).

Best wishes

BAU: Business As Usual

CI: Chief Investigator

CPMS: Central Portfolio Management System

CTU/CRO: Clinical Trials Unit/Clinical Research Organisation

DHSC: Department of Health and Social Care

ETCs: Excess Treatment Cost(s)

GDPR: General Data Protection Regulation

ICB: Integrated Care board

LPMS: Local Portfolio Management Systems

ODP: Open Data Platform

POF: Performance & Operating Framework

PSP: POF Support Page

R&D: Research & Delivery

RDN: Research Delivery Network

RDNCC: Research Delivery Network Coordinating Centre

RRDN: Regional Research Delivery Network

SOP: Standard Operating Procedure

SPOC: Single Point of Contact

T&Cs: Terms and Conditions

Version 1.1

October 2024