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NIHR single costing methodology: Procedures Definitions and Tariff 2019/20 Version 1.1

 

Contents

Industry Costing Template Procedures Definitions and Tariff 2019/20 Version 1.1 – 18th March 2019

 

Section 1 - Description of document

Document content

This definition and tariff has been created to assist both Industry and NHS partners to create consistent and meaningful costings for Industry sponsored research within the NHS.

Values within this tariff solely define the relevant labour time required by research staff to initiate, carry out or report on the activity described within the Investigation and Intervention Tariff document. All entries contain the following:

  • Grantplan or NIHR Coding - Codes from the Industry Grantplan software or NIHR coding (for reference) where Grantplan coding is absent.
  • Activity Description - Brief Description of activity taking place
  • Department - Defined department that covers the activity (this may vary from one NHS organisation to another.
  • Notes - Whether the activity is a single investigation, an intervention with associated investigation or a unit cost activity at setup or during the project.
  • Timings - The defined unitary timings for the activity

Please note that these are NHS baseline timimgs only and do not represent costs provided by commercial or academic units. A degree of consideration will be required in order to cost any of these items in conjunction with external NHS SLAs contract to either of these entities.

 

Acknowledgements

All costs in this document have been collated with the assistance of the following institutions and have been overseen and ratified by the Industry Costing Template Working Group, hosted by the NIHR CC. ? The Royal College of Pathologists

  • Leeds Teaching Hospitals NHS Trust
  • Royal College of Surgeons
  • Bradford Opthalmology Research Network
  • University College London Hospitals NHS Foundation Trust
  • Barts Health NHS Trust
  • Queen Mary University of London
  • Norfolk and Norwich NHS Foundation Trust
  • NHS Health Education East of England
  • National Pharmacy Clinical Trials Advisory Group
  • The Shelford Group
  • ECMC
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation Trust

Usage Disclaimer

All costs included herein are subject to change and amendment. Recommendations for additions and amendments should be sent to phillip.good@nihr.ac.uk

Section 2 – Study Team tariffs

Grantplan or NIHR Coding Activity Description Notes Clinical Time [Consultant] Nurse Ti me [Band 7] Admin Time [Band 4]
NIHR_PR C_001 Informed consent Nurse time refers to the study being discussed with the patient prior to consent and signature which is represented by the Clinical (Doctor) time. Nurse time will include the patients being informed of their rights (informed consent process according to GCP guidelines), preliminary reviews of inclusion/exclusion criteria, concomitant medications and medical (with condition history if applicable) and previous laboratory test results if appropriate (please note that these reviews may/will also be conducted by the doctor at the screening visits). Times allocated are dependent on complexity of study and the patient group (cognitive level) and the following time are provided as initial guidance only: From 30 mins for simple complexity (Observational, Genetic databases), From 45 mins medium complexity (majority of types of studies), From 60 mins complex (e.g. monoclonal studies), From 15 mins ADDITIONAL time if patient population requires (e.g. level of cognitive function). Other considerations which may require additional time includes: Pre-screen checks, pre-screen discussion with patient (nurse and PI or referring consultant), handling patient call query when reviewing information, attendance at Screening visit with further questions, the Caregiver or family members may have queries, which may be more common for patient home visits or inclusion of genetic sample requirements. Re-consenting patients following protocol amendment may be required and could be included as an Additional Itemised Cost line item to enable invoicing as required. 60 60 0
NIHR_PR C_002 Consent for Genetic Sample Nurse time refers to the implications of genetic sampling being discussed with the patient prior to consent for this procedure as a standalone consent 10 10 0
NIHR_PR C_003 Medical history May include other information covering demographics, concomitant illnesses or inclusion/exclusion related questions. For some conditions, further information maybe needed around previous treatments or condition history e.g. Diabetes, oncology, Alzheimer''s Disease which may require more time to be included. This could add from 15 mins Clinical time and from 60 mins nurse time depending on requirements and whether discussion have been part of informed consent process 30 30 0
NIHR_PR C_004 Blood sample - collection only Blood sample collection only. Chargeable per patient collection (blood draw) not per tube. Covers preparation (e.g. cannulation if used), equipment, collection and paperwork. Cost EXCLUDES processing - if required please select additional line item for blood sample collection processing. May need to consider time adjustments when collection is outside of normal working hours (e.g. access restrictions). Where applicable ensure investigator time is included for sign-off’. May be required for pregnancy test (serum hCG) - amend descriptive text to show inclusion as required. 0 15 0
NIHR_PR C_005 Blood sample - collection processing Blood sample collection processing only (EXCLUDES collection - this is a separate line item). Times to be adjusted as per processing requirements in the protocol. The separate Specimen dispatch item should be selected if using off-site lab (e.g. central lab). May need to consider time adjustments when collection is outside of normal working hours (e.g. access restrictions). Where applicable ensure investigator time is included for sign-off. May be required for pregnancy test (serum hCG at local or central lab) - amend descriptive text to show inclusion as required. 0 30 0
NIHR_PR C_006 Specimen Dispatch by post/courier Time for staff to package specimens to confirm to appropriate UN Packing standard, arrangement of courier and associated paperwork. Separate line items enables reflective of batch couriering for patient samples if possible. 0 30 0
NIHR_PR C_007 Vital Signs measurement s (Temp, BP, Pulse and respiration) Covering Temperature, blood pressure, pulse rate and respiration rate 10 10 0
NIHR_PR C_008 Weight & Height (including BMI if required) Additional time may be required if patient has mobility or disability which requires transfer from wheelchair and back or support requirements during measurement. Time may vary depending on equipment or BMI calculation method required by protocol. 0 5 0
NIHR_PR C_009 Waist and Hip Circumferenc e Waist and Hip Circumference measurement  0 0 5
NIHR_PR C_010 Blood pressure (only) Line item for use when measurement is performed independently of the vital signs assessments. Time is dependent on specific instructions 0 10 0
NIHR_PR C_011 Physical examination Timings assume patient without a condition that would result in requiring additional time e.g.. mobility problems Nurse may need follow up by contacting GP or other consultants for results of previous tests. May require different examinations e.g. eye examinations by fundoscopy (5min clinical time) for diabetic patients which would be helpful to list in procedure description to aid review 30 20 0
NIHR_PR C_012 Urinalysis - Urine collection only (at clinic) Time allocated covers sample collection only. Processing of sample is included as a separate line item. Time value may need adjustment to include time for support for patient to get on/off the toilet if required. May be required for pregnancy test. 0 5 0
NIHR_PR C_013 Urinalysis - Urine processing (dipstick or sample preparation) Processing of collected Urine (e.g. volume measurement, acidification, centrifugation, transfer of containers) for lab investigations. Processing time may be adjusted to reflect the processing requirements of the protocol including sending off a culture and sensitivity to local labs and following up results. Associated investigation cost may also be required. May be required for pregnancy test. 0 5 0
 NIHR_PR C_014  Spirometry  Includes preparation, use and cleaning of spirometer equipment and standard consumables for investigation  0 20 0
NIHR_PR C_015 Randomisati on (manual, IVRS or IWRS) Randomisation charge per requirement includes allocation of subject number and may be up to 60 mins for oncology studies. Line item is charged per dial in requirement where applicable. Note some studies may require dual dial-in e.g. Pharmacy then clinical staff. Time shown should be adjust to reflect average time required for randomisation. Review of randomisation criteria after run-in period may also be required 0 15 0
NIHR_PR C_016 Instructions/ education for patient and/or care giver Explaining study procedures to patient and/or care giver, discussion around drug regimen and SAEs. 15 15 0
NIHR_PR C_017 Subject Questionnair e Variable depending on questionnaire required 0 30 0
NIHR_PR C_018 Review Questionnair e Variable depending on questionnaire completed 0 30 0
NIHR_PR C_019 Concomitant medication check (at screening) Complex PD drug regimes may require this procedure  5 15 0
NIHR_PR C_020 Concomitant medication check (on study) Complex PD drug regimes may require this procedure  0 5 0
NIHR_PR C_021 Prescription for study   5 15 0
NIHR_PR C_022 Administer study drug in clinic Variable time depending on study drug administration method required by the protocol. Time should include clinical preparation, administration of study drug and observation. 15 30 0
NIHR_PR C_023 Dispense diaries and instruct   0 15 0
NIHR_PR C_024 Collect and review diaries   0 15 0
NIHR_PR C_025 Drug accountabilit y and compliance Clinical staff responsibility (should not be duplicated with Pharmacy) 0 10 0
NIHR_PR C_026 CRF/eCRF completion including data transfer and query resolution

Variable time depending on amount and type of data collected per visit e.g. complex visit (e.g. Screening or End-of-Study), standard visit or simple visit (e.g. logging phone contact/survival). A time per page to complete approach could be used to calculate actually time needed. Clinicians are usually required to sign off (especially lab results and eCRFs) so clinical time should always be considered. Time includes data query resolution time: calculation of time may require an assumption for the number of queries per patient If required, time should be adjusted to include transfer of patient note information into a Case Report Form (CRF), Electronic Data Capture (EDC) system or and electronic CRF (eCRF) which may include

- transcribing into hospital notes and the hospital electronic patient system (if applicable) from one of the sources above - transcribing and reporting of diaries, questionnaires, profiles and titrations.

15 60 0
NIHR_PR C_027 Review/repor ting of patient AEs/SAEs Time allocated per AE/SAE so may require an assumption for the number of AE/SAE per patient or inclusion in the 'Additional Itemised Cost' section instead of 'Per Patient'. Nurse time could be up to 30 for an oncology patient or other complex patient condition studies, which needs to be considered when assigning time. 5 30 0
NIHR_PR C_028 C_028 Handover to routine care (End of Trial) Time for patient study sign-off including letter to Patient's GP and/or handover to routine care. Includes time to confirm if patient completed the study as per the protocol (Y/N) and/or withdrawn (Y/N) 15 0 0
NIHR_PR C_029 Device calibration / alteration of mechanical device settings and monitoring When devices are used in patient care and integrated into trials, the settings need calibrating, monitoring and altering for the patient 0 5 0
NIHR_PR C_030 Monitoring on-site visits or risk/remote based monitoring communicati on Time can be allocated per patient visit which is monitored and is variable depending on duration of the study, requirements of visit and monitoring visit schedule. If inclusion of risk/remote based monitoring communication as an alternative to on-site visits, the monitoring plan should be consulted to ensure monitoring visit frequency and durations are appropriately included. This may be also included in the 'Additional Itemised Cost' section if the monitoring visit frequency is not aligned with patient visits. Clinical time may also be needed for inclusion if requested. As a guidance, CRAs can monitor approximately 10 patient visits at each visit. 0 5 0
NIHR_PR C_031 Disseminatio n of study results to participants Investigator time to receive and read the Clinical Study Report (CSR) or synopsis and disseminate the results of the study to the study participants. 30 30 0
NIHR_PR C_040 Patient Eligibility Assessment Time taken to assess the patient against the inclusion, exclusion and medical history criteria for the study 30 0 0
NIHR_PR C_041 ECOG Status Time taken to assess the patient against the inclusion, exclusion and medical history criteria for the study 5 0 0
NIHR_PR C_042 Pulse Oximetry Time taken to carry out testing that measures your oxygen saturation level, or the oxygen levels in a recruits blood 0 5 0
NIHR_PR C_043 Reconsenting Time taken, if necessary, for subjects to reaffirm their decision to participate, to reconsent, or to sign or re-sign a document 15 15 0

 

Section 3 - Pharmacy tariffs

Grantplan or NIHR Coding Activity Description Notes Clinical Time [Consultant] Nurse Time [Band 7] Admin Time [Band 4]
NIHR_PRC_033  Dispensing time for standard agent or IMP/NIMP (excluding use of IVR/IWR) Pharmacy Activity 0 35 0
NIHR_PRC_034 Aseptic dispensing agent time Pharmacy Activity 0 85 0
NIHR_PRC_035 Controlled drug - additional dispensing time Pharmacy Activity 0 40 0
NIHR_PRC_036 Advanced therapy - additional preparation time [where relevant] Pharmacy Activity 0 180 0
NIHR_PRC_037 Use of IVR/IWR system (only chargeable if performed by Pharmacy) Pharmacy Activity 0 16 0
NIHR_PRC_038 Pharmacy arrangement of IMP delivery or posting preparation time to the patient Pharmacy Activity 0 20 0
NIHR_PRC_039 Individual patient drug accountability time Pharmacy Activity 0 35 0