CSP002: Method for calculating the NIHR CRN High Level Objectives (HLOs) 2023/24

Acronyms

• CRN = Clinical Research Network

• LCRN = Local Clinical Research Network

• MHRA CT = Medicines and Healthcare products Regulatory Agency Clinical Trial

• n/a = Not Applicable 

• PRES = Participant Research Experience Survey

Objective

Support sponsors to deliver their NIHR CRN Portfolio studies to recruitment target

Measure

Percentage of open to recruitment commercial contract studies which are predicted to achieve their recruitment target

Ambition

80%

Level

CRN

Calculation

To be classed as On Track (predicted to achieve recruitment target), a study must have: 

Recruitment to Time and Target greater than or equal to 0 

Or, if Recruitment to Time and Target is less than 0, the following must apply:

Sponsor Agreed Intention = 'On track as per study milestones'

Notes

• Recruitment to Time and Target = (Recruitment to Target divided by Percentage of recruitment period elapsed) minus 1

• Recruitment to Target = Recruitment at Network Sites divided by Network Target

• Percentage of recruitment period elapsed = (Number of days open divided by Number of planned days open) multiplied by 100

Objective

Support sponsors to deliver their NIHR CRN Portfolio studies to recruitment target

Measure

Percentage of open to recruitment non-commercial studies which are predicted to achieve their recruitment target

Ambition

80%

Level

CRN

Calculation

To be classed as On Track (predicted to achieve recruitment target), a study must have: 

Recruitment to Time and Target greater than or equal to 0 

Or, if Recruitment to Time and Target is less than 0, the following must apply:

Sponsor Agreed Intention = 'On track as per study milestones' and Funder Agreement is not equal to 'Disagree with sponsor intention'

Notes

• Recruitment to Time and Target = (Recruitment to Target divided by Percentage of recruitment period elapsed) minus 1

• Recruitment to Target = Recruitment at Network Sites divided by Network Target

• Percentage of recruitment period elapsed = (Number of days open divided by Number of planned days open) multiplied by 100

The contents of Table 2 (Study Delivery (7)) are identical to the contents of Table 1 (Study Delivery (6)), with the following exceptions:

• Study Route Details (inclusion/exclusion criteria in the Details column in Table 2)

• Site Selected Details (inclusion/exclusion criteria in the Details column in Table 2)

• Network Supported [Site] Details (inclusion/exclusion criteria in the Details column in Table 2)

• CPMS Data Point 'Recruitment at Network Sites' has been replaced with CPMS Data Point 'Recruitment'

• ODP Data Point 'Network Recruitment' has been replaced with ODP Data Point 'England Recruitment'

• The details for CPMS Data Point 'Recruitment' and ODP Data Point 'England Recruitment' are as follows: 'Sum of recruitment at study sites, Excluded: Research Activity Type of Screen Failure or Consented'

• ODP Data Point 'Study Agreed Intention, Funder Agreement' has been replaced with ODP Data Point 'Sponsor Agreed Intention, Funder Agreement'

• The details for ODP Data Point 'Sponsor Agreed Intention, Funder Agreement' are as follows: Where 'Sponsor Agreed Intention' = 'On track as per agreed intention' and 'Funder Agreement' does not equal 'Disagree with sponsor intention', then the Study is deemed to be on track to achieve its recruitment target

Objective

Demonstrate to participants in NIHR CRN supported research that their contribution is valued through collecting their feedback and using this to inform improvement in research delivery 

Measure

Number of NIHR CRN Portfolio study participants responding to the Participant Research Experience Survey

Ambition

18,000

Level

CRN

Calculation

Sum of PRES returns across England

Objective

Sustain or grow commercial contract research

Measure

Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total MHRA CT approvals for PHASE II-IV studies

Ambition

75%

Level

CRN

Calculation

The number of interventional phase II-IV commercial studies entered on the NIHR CRN Portfolio divided by the number of commercial studies approved by MHRA CTA

Version: 1.1

Effective from: 13 September 2023