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					                            Primary Care Costing Template
                                                    Version 1.0
This template is for the negotiation of costs associated with NIHR CRN adopted commercial primary care based studies.
       Costs should be considered negotiable until agreed and finalised with the site in a Clinical Trial Agreement

                                              Monday, November 15, 2010
                                                      Recipient:
                                                       NAME
                                                       TRUST
                                               SITE/DEPARTMENT/UNIT
                                                         Tel:
                                                        Email:

                                              Please direct all question to:
                                               COMPANY/SPONSOR
                                                         NAME
                                                         TITLE
                                                          Tel:
                                                         Email:



          Confidentiality Notice: This file may contain confidential or legally privileged information that is
          intended only for the individual or entity named above. If you are not the intended recipient, you
          are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this
          file is strictly prohibited. If you have received this file in error, please reply to the NIHR CRN
Study Information


Please complete below the relevant study information on this tab. The Primary Care Costing Template will use the information provided in its calculations. Additionally, the sections below
will help indicate which sections of this Template that will need to be completed in order to capture the costs associate with your intended study design.


   Study Title/Acronym:              EXaMpLE - A double blind, randomised control trial in …..
   NIHR CRN Study Number:
   Protocol Number:
   Study Adoption / Submission Status:             In Review for Adoption

   Area of Research:
   Investigator:
   Contact Details:
                           Tel:
                        Email:
   Principal research site:



                                                                       Please select a Trust from the drop-down menu below:                               Payment by Results Market Forces Factor
Please select the Trust for which the Template will be negotiated
                                                                      BLANK PbR MFF - Sites to be determined
                                                                                  1
                                                                                                                                                                 inc. PbR
and finalised:


   Intended duration of the study:                                                                                  0        months


   Total number of patients/participants to be recruited for this study site:                                       0        patients/participants


                                                                                                                                  You will need to complete the Per Patient Budget and R&D
   Will the study require the research team to provide assessments and evaluations?                               YES
                                                                                                                                  and Other Costs Sections


                                                                                                                                  You will need to complete the investigations section of the
   Will the study design require any lab, tests, or scans?                                                        YES
                                                                                                                                  Per Patient Budget and R&D and Other Costs Sections



   Will the study require a secondary care NHS site to prepare and manage the study drug?                         YES             You will need to complete the Pharmacy Section



Costing Elements used in the NIHR CRN Primary Care Costing Template
   Standardised staff grades and rates used 2010 - 2011:
                                                                                                                             Hourly rate Inclusive of Overhead
                                                Salary Band:                          Hourly rate:                           and Capacity Building Element:
                              Clinical Staff:      NIHR CRN GP Rate                    £                          80.00       £                124.00
                               Nurse Staff:     Top Band 7 Agenda for Change           £                          29.95       £                  43.43
                         Pharmacy Staff:        Top Band 7 Agenda for Change           £                          29.95       £                  43.43
                       Practice manager:        Top Band 7 Agenda for Change           £                          29.95       £                  43.43
       Administrative/ Data mgmt Staff:         Top Band 3 Agenda for Change           £                          13.84       £                  20.06
                                                                                      Note: Hourly Rates include NIC and NHS Superannuation Scheme
                Overhead Element rate:                  25%                 Note: applies to procedure based staff costs only, as investigations already inclusive of Trust's overhead


         Capacity Building Element rate                 20%                 Note: applies to procedures and investigations
Primary Care Costing Template - Per Patient Budget

The procedures and activities below document the as determined by the study protocol. The patient care activities should be considered in comparison to the site's current treatment pathway and
standard-of-care. Several activities and study costs which cannot be reliably predicted to occur may be documented on the R&D and Other Costs section.


Study Research Procedures and Related Activities:
Procedures are any protocol related activities, screening or assessments to be undertaking by member of the research team
                                                                                                                                                                                                                                                                                                                                                  TOTAL                        Total for BLANK PbR MFF -
                                                                                                                                                                                                                                                                                                           Procedure price adjusted for           including all Costing        Sites to be determined
                                                                                                                                                        Please add number of times each activity occurs at each visit. This will most often be 1.                                                          costing elements                       Template Elements :          including PbR MFF
                                                                GP                          Practice        Admin      Calculated payment based                                                                                                                                                                                    Capacity                                    TOTAL Staff Price including
                      Procedures                                         Nurse Time                                                                       Visit 1       Visit 2      Visit 3      Visit 4      Visit 5      Visit 6      Visit 7    Visit 8   Visit 9   Visit   Visit       Subtotal            Overhead                               TOTAL Staff Price
                                                               Time                         Manager         Time           on time and costs                                                                                                                                                                                       Building                                            PbR MFF
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                  £0.00                                                                                                                                                 £              -    £              -   £              -    £                       -   £                      -
                                                                                                                                                             0            0            0            0             0            0            0         0         0        0       0      £              -    £              -   £              -    £                       -    £                          -



Select an activity to be added to the list of procedures
                                                           1                                             Per Visit Time allocations for research staff (minutes per visit)
                                                                                                                                       Total GP time:        0            0            0            0             0            0            0         0         0        0       0
                                                                                                                                    Total nurse time:        0            0            0            0             0            0            0         0         0        0       0
                                                                                                                        Total practice manager time:         0            0            0            0             0            0            0         0         0        0       0
                                                                                                                                   Total admin time:         0            0            0            0             0            0            0         0         0        0       0
                                                                                                                                                                                                                                                                                                                                                                                                                          TOTAL                             Total for BLANK PbR MFF -
Study Investigations                                                                                                                                                                                                                                                                                                                                                                   Investigation price adjusted       including all Costing             Sites to be determined
Investigations are the labs, tests, scans, sampling and other diagnostic and investigative procedures offered by service support departments                Please add number of times each activity occurs at each visit. This will most often be 1.                                                                                                                                  for costing elements               Template Elements :               including PbR MFF

                                                                                                                                                                                                                                                                                                                                                                                             Capacity Building                                               TOTAL Investigation Price
                     Investigations                                                                                      Price of investigation                  Visit 1           Visit 2           Visit 3           Visit 4           Visit 5           Visit 6           Visit 7           Visit 8           Visit 9           Visit           Visit           Subtotal                                                TOTAL Investigations Price
                                                                                                                                                                                                                                                                                                                                                                                                                                                               including PbR MFF

                                                                                                                                                                                                                                                                                                                                                               £                  -     £                             -    £                            -   £                      -
                                                                                                                                                                                                                                                                                                                                                               £                  -     £                             -    £                            -   £                      -
                                                                                                                                                                                                                                                                                                                                                               £                  -     £                             -    £                            -   £                      -
                                                                                                                                                                                                                                                                                                                                                               £                  -     £                             -    £                            -   £                      -
                                                                                                                                                                                                                                                                                                                                                               £                  -     £                             -    £                            -   £                      -
                                                                                                                                                                                                                                                                                                                                                               £                  -     £                             -    £                            -   £                      -


Select an investigation to be added to the investigations list

                                                         1
To see a complete list of investigations, and the activities they include, please see the information on the ABOUT THIS TEMPLATE SECTION.
                                                                                        Per Visit Staff and Investigation costs
                                                                                                                                  Total GP cost per visit    £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -
                                                                                                                              Total nurse cost per visit     £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -
                                                                                                                  Total practice manager cost per visit      £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -
                                                                                                                             Total admin cost per visit      £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -
                                                                                                                          Investigations price per visit     £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -

                                                                                                                                                                                                                                                                                                                                                                              Totals
                                                                           TOTAL price (staff+investigations) per visit with Indirect Costs                  £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -   £                  -
                                                                           TOTAL price (staff + investgations) per visit including PbR MFF                   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £             -   £           -   £           -   £                  -



                                                                                                                       Per Patient Budget Combined Totals:
                                                                                                                                                                                                                                                                                                                                                                      Subtotal costs - Per Patient Budget :                £                            -

                                                                                                                                                                                                                                                                                                                                                                                       Subtotal Overheads :                £                            -

                                                                                                                                                                                                                                                                                                                                                                              Subtotal Capacity Building :                 £                            -

                                                                                                                                                                                                                                                                                                                               TOTAL Per patient budget including all Costing Template Elements :                          £                            -

                                                                                                                                                                                                                                                            TOTAL Per Patient Budget for BLANK PbR MFF - Sites to be determined (inclusive of PbR MFF)                                                                     £                        -
PHARMACY SERVICES
Study Information - Pharmacy:
                                                               Number of dispensings per patient:                 Anticipated number of visits                        Total number of Pharmacy
      Predicted number of patients at the site:                                                                   requiring dispensing:
                                                               (what is meant by dispensings?)                                                                        dispensings for the study:                                                                                        Pharmacy activities price breakdown

                        0                                                        0                                               0                                                     0                        TOTAL                            Total for BLANK PbR MFF
                                                                                                                                                                                                                including all Costing            - Sites to be determined                                      Activity price adjusted for
                                                                                                                                                                                                                Template Elements :              including PbR MFF                      Activity Price         costing elements
                                                                                                                                                                                                                                                   TOTAL Price including                                                          Capacity       TOTAL ACTIVITY
                                                                                                                                                                                                                     TOTAL Activity Price                                                    Subtotal           Overhead
                    Activity                                                  Notes                                     Time (in minutes)                                     Applicability                                                             PbR MFF                                                                   Building       PRICE
Activities costed per patient                                                                                                                           35

                                                        Priced as average dispensing per drug (IMP or                           25
      Dispensing (dispensary only)                                                                                                                                                                               £                           -    £                             -        £         12.48        £        3.12     £     2.50     £         18.09
                                                        other agent)

      Does the study involve any                               Number of agents that are                                 An additional 10 minutes is added to the "basic" dispensing time of 25 minutes per item
      Controlled Drugs?                                        controlled drugs:

                                                                                                                                10                                                                               £                           -    £                             -        £              4.99    £        1.25     £     1.00     £          7.24
                       NO                                                        0

                                                               Only charged when specifically                                   15                               Check if medical reconcilliation req.                                            £                             -
      Medicine Reconciliation                                  requested or required
                                                                                                                                                                                                                 £                           -                                           £              7.49    £        1.87     £     1.50     £         10.86
                                                                                                                                                                                                    FALSE

      NHS (England) Prescription charge for                                                                   Check if Prescription charge applicable                                                                                             £                             -
                                                               £7.20 per item applicable to every drug                                                                                                           £                           -                                                                                                   £          7.20
      outpatients @ current NHS rate                                                                                                                                              FALSE

      Posting /arranging IMP delivery to                       Sponsor to pay costs in addition to cost                         15                                Check if IMP posting required                                                   £                             -
                                                               of pharmacy time spent
                                                                                                                                                                                                                 £                           -                                           £              7.49    £        1.87     £     1.50     £         10.86
      patient                                                                                                                                                                                          FALSE
                                                               Number of agents requiring
                                                               aseptic compounding on each                        No. of visits requiring
      Aseptic Compounding Required                             visit :                                            aseptic compounding          Time

                                                                                                                                                                                                                 £                           -    £                             -        £         29.95        £        7.49     £     5.99     £         43.43
                       NO                                                        0                                       0                       60
                                                               To be priced per item at cost per dose
      IMP-specific consumables                                 only when specifically requested or
                                                               required



Set Up and Close Activities:                            Pharmaceutical services have been divided into three categories which reflect the complexity of pharmaceutical services required for different types of studies. These fees are payable only once.


Click here to view what activities are covered under the Set-Up and Close Down Fee
                                                        Select this category if a dispensary based
      Pharmaceutical study type A                       study with no aseptic compounding required                                                               Check if TYPE A applies                         £                           -    £                             -        £                -     £             -   £          -    £           -
                                                        (single site only)                                                      900                                               FALSE
                                                        Select this category if the study involves only
      Pharmaceutical study type B                       aseptic compounding and no dispensing                                                                    Check if TYPE B applies                         £                           -    £                             -        £                -     £             -   £          -    £           -
                                                        activity (single site only)                                            1200                                            FALSE
                                                        Select this category if the study requires both
      Pharmaceutical study type C                       dispensary and aseptic handling (single site                                                             Check if TYPE C applies                         £                           -    £                             -        £                -     £             -   £          -    £           -
                                                        only)                                                                  1800                                            FALSE
                                                        This fee applies when any trial specific
                                                        pharmacy activities have to be carried out by
      Each additional hospital site                     staff on a remote site necessitating training of                                                         Check if additional sites are required          £                           -    £                             -        £                -     £             -   £          -    £           -
                                                        staff, creation of files, holding of records etc on
                                                        such sites                                                              300                                               FALSE


Trial Maintenance Activities:                           Ongoing maintenance activities for the study research agents.

Click here to view what activities are covered under the Trial Maintenance Activities
      Duration of the study (MONTHS)
                                                                                                                                                                 Check if trial maintenance activities
                                                                                                                                120                                                                              £                           -    £                             -        £         59.90        £       14.98     £    11.98     £         86.86
                        0                                      At a rate of £84.91 per month                                                                     required                            FALSE


Other Pharmacy Services:                                                                                                                                      Activity Rate / Charge

      The following activities will be included in the mCTA and invoiced to the Sponsor as incurred through the course of the study
      at the Industry Costing Template Rate or as otherwise indicated:
         - Re-labelling and releasing of IMP batch
                                                                                                                                                                                   £42.46
         - Dedicated audit time with CRA or other Sponsor affiliate
         - Extending working hours (Usual staff rate + 50%)
         - Out-of-hours working (Usual staff rate + 100%)

                                   2                           Sponsors are encouraged to discuss packaging & presentation of medicines &
      Storage space over 0.5m approx. ( =                                                                                                                                     £50 per month                                                       £                             -
      one shelf 0.3m deep x 1.5m long)                         proposed arrangements for supply and storage as early as possible

                                                               Storage pending collection or disposal : sponsors are expected to take responsibility for
                                                               timely collection of all unused/unwanted/expired medicines originally supplied by them.    £100 per month or part thereof. £25 per 50L
      Waste disposal :                                         Charges will apply only if such waste is not collected within 1 month of the first request                                                                                         £                             -
                                                                                                                                                                          container
                                                               to collect. Disposal as hazardous waste

      Purchase of fridge, freezer or other              Companies to be charged cost rate                                                                                                                                                         £                             -
      dedicated equipment


                                                        Pharmacy Service Totals                                                                                                                                                                                                         Per dispensing         Per Patient
                                                                                                                                                                                                         Subtotal pharmacy service costs:
                                                                                                                                                                                                                                                   £                                -
                                                                                                                                                                                                  (excluding fees and prescription charge)                                                    #DIV/0!               #DIV/0!

                                                                                                                                                                   Subtotal Overhead Element (of pharmacy cost above) :                            £                                -
                                                                                                                                                                                                                                                                                              #DIV/0!               #DIV/0!

                                                                                                                                                      Subtotal Capacity Building Element (of pharmacy cost above) :                                £                                -
                                                                                                                                                                                                                                                                                              #DIV/0!               #DIV/0!
                                                                                                                                              TOTAL Pharmacy costs including all Costing Template Elements :                                       £                                -
                                                                                TOTAL Pharmacy Service Costs for BLANK PbR MFF - Sites to be determined (inclusive of PbR MFF)                                                                        £                             -




Pharmacy Definitions-

                    What is meant by                           dispensing one Investigational Medicinal Product on one occasion for one patient                                                                                                                                         click here to return to the top
                    dispensings?



                                                               The current regulations state that the NHS prescription charge must be levied on all medicines dispensed to outpatients participating in clinical trials, unless there is a placebo treatment arm. Trusts are
                    NHS prescription charge                    legally bound to collect these charges although in some trusts the Finance Director may make a local decision not to do so if they believe that the costs of collection are likely to significantly exceed the           click here to return to the top
                                                               value of charges to be collected. For Trusts whose policy is to comply fully with the Prescription Charge Regulations, it is legitimate for these costs to be re-charged to the sponsor



             The following activities are included                     The following activities are                                                          The following activities are included in the
             in the Dispensing Fee:                                    included in the Set Up and Close                                                      Trial Maintenance Activities:
                                                                       Down Fees:
             Prescription screening                                                                                                                          Routine stock orders
             Dispensing & labelling                                    Review protocol                                                                       Stock checks
             Routine stock accountability                              Feasibility assessment                                                                Issue confirmation of receipt of study drugs
             Aseptic compounding incl. essential pre-                  Communication with the sponsor                                                        Manual ordering of drugs
             and post-dose set-up and clean-down                       Participation in mandatory local                                                      Returning unused expired stock
             Dedicated consumables ( costed per                        review and approval processes                                                         Invoicing requests to finance
             dose )                                                    Attendance at meetings & liaison                                                      Protocol amendments
             Reconciliation of individual patient                      with PI, Research Nurse, CRA                                                          IVRS
             supplies                                                  Write bespoke prescribing guide                                                       Transit and Storage temperature monitoring
             Re-ordering of individual named-patient                   Write & approve bespoke                                                               Brief, periodic monitoring visits (separate and
             supplies                                                  dispensary SOPs                                                                       different to dedicated time with Pharmacy staff)
             Utilising IVRS                                            Set up dispensing & stock control
             Randomisation of new participants if                      software systems and
             agreed as a pharmacy role                                 documentation
                                                                       Set-up electronic prescribing
                                                                       systems, where applicable
                                                                       Set up supply systems
                                                                       Train dispensary staff
                                                                       Write and approve bespoke
                                                                       technical services SOPs, where
                                                                       applicable
                                                                       QP documents
                                                                       QP release
                                                                       Design worksheets & other
                                                                       mandatory working documents
                                                                       Set-up electronic workload
                                                                       management systems in technical
Click here to return to the top                                click here to return to the top                                              click here to return to the top
                R&D and Other Services

                NHS TRUST R&D MANAGEMENT

                                    Acceptance of the Proposed Set Up Fee                                     YES

                         Proposed Set Up Fee using standard NIHR CRN process
                                (recommended national average = £350)                                       £350.00
                          what pre-trial activities does the proposed fee cover?

                   Payment by Results MFF for BLANK PbR MFF - Sites to be determined
                                                                                                            0.00000
                           Total fee for BLANK PbR MFF - Sites to be determined                               £0.00



                SCREENING FEE                                                                                             Cost (£)
                                                                  Predicted number of patients enrolled at the site           0

                                                                     Screen Failure percentage (e.g., 20%, 5%, etc.)        0.0%

                                                                               Screening fee to be paid per patient         £0.00

                                                                                                                  Total     £0.00


                PRIMARY CARE REFERRAL SERVICES                                                                            Cost (£)
                                      Practioner Note Search and Patient Admission Database Search                          £0.00
                                                                             Estimated Number of Patient Referrals            0
                                                  Payment For Referrals That Lead To A Successful Randomisation             £0.00
                                               Expected Percentage of Referrals that will be Successfully Enrolled          0.0%
                                                                                                                  Total     £0.00



                REFRESHMENTS                                                                                              Cost (£)
                                                                          Refreshment costs for patient per visit           £0.00
                                                                  Refreshment costs for patient and carer per visit         £0.00
                                                                                           Total Visits per Patient           0
                                                                                                    Total Patients            0
                                                                                                                Total       £0.00


                PATIENT TRAVEL COSTS                                                                                      Cost (£)
                                                                           Maximum travel costs per patient per visit

                ARCHIVING                                                                                                 Total (£)

                NOTE: If an Archiving activity is required than the rate is to be calculated per box per month of storage at an
                agree third party provider rate

                ADDITIONAL ITEMISED COSTS                                                                                 Cost (£)




Find me third
                                                                                                                  Total     £0.00
Study Budget Summary

                                                  Study information
                                      Study Title/Acronym:                   EXaMpLE - A double blind, randomised control trial in …..

                   Number of patients/participants to be recruited:                   0

                                                Summary Budget for :              BLANK PbR MFF - Sites to be determined



    Study Budget Summary including Pharmacy and Other Costs
                                                                                                         Subtotal                   TOTAL
                                                                                  Subtotal                                                                           TOTAL
                                                      Subtotal costs -                                   Capacity                   including all Costing
                                                                                  Overheads :                                                                        Inclusive of PbR MFF :
Per Patient Budget :                                                                                     Building :                 Template Elements :
                         Procedure Costs £                            -       £              -      £                   -       £                            -   £                          -

                      Investigation Costs £                           -                             £                   -       £                            -   £                          -


      Total for all 0 participants:               £                   -       £              -      £                   -       £                            -   £                          -




                       Pharmacy Fees              £                   -       £              -      £                   -       £                            -   £                          -

                                  Screening                                                                                     £                            -   £                          -

                             Refreshments                                                                                       £                            -   £                          -

                             Patient Travel                                                                                     £                            -

                                   Archiving                                                                                    £                            -

      Primary Care Referral Services                                                                                            £                            -
    Note: A total above does not constitutes agreement with referring sites. Referral activities and payments will need to agreed with each referring site




                     Additional Costs                                                                                           £                            -   £                          -
    Note: There are Pharmacy and Additional Costs that will need to be considered separate from these totals. These should be documented uniquely in
    the Clinical Trial Agreement

                                                                                                                                                                     Total
          NHS R&D Management:                                                                                                       Set-Up Fee:                      Inclusive of PbR MFF

                       Acceptance of the Proposed Set Up Fee:                        YES                                                     £350.00             £                          -




STUDY BUDGET TOTALS - inclusive of all patients and all study related activities from the Template
                                    Subtotal:
                                                                          Study Costs :              £                      -
                                                                           Overheads :               £                      -
                                                                 Capacity Building :                 £                      -
                           TOTAL including all Costing Template Elements :                          £               350.00

TOTAL inclusive of PbR MFF for BLANK PbR MFF - Sites to be determined:                               £                      -




                                                   STUDY BUDGET TOTAL :                              £                                                  350.00
Primary Costing Template Version 1.0


Helpful information (click on a topic below to follow the link)
how to complete the Primary Care Costing Template
security settings
rates used in the Primary Care Costing Template
how to add a PbR MFF
how to complete the pharmacy section
what to consider on the r&d and other costs section
investigations lists
the NIHR CRN Costing Programme
how to contact the NIHR CRN with a costing query
how to arrange training for your team on the use of NIHR CRN costing templates




How to complete the Primary Care Costing Template
Please read these instructions . You may find it helpful to print them off before you start.

The Primary Care Costing Template should be completed by companies (Sponsor or CRO) at the point of submission for NIHR CRN Industry Adoption. It will calculate the price per site, OR
alternatively, can be used to assess the costs of a clinical study and provides a full breakdown of costs and prices for individual studies. It will be used within the Networks to negotiate with
individual sites. There are ten pages within the Costing Template and companies are requested to complete all relevant pages for their study.


**The Costing Template provides a transparent, comprehensive and consistent costing framework thereby enabling timely negotiations. All costs calculated
with the Costing Template should be considered negotiable until finalised and agreed upon by all parties following review and revision**


For further information or advice please contact crncc.costinghelp@nihr.ac.uk or call 0113 343 0341. Additional information is available on the NIHR CRN website www.crncc.nihr.ac.uk/industry.



Security Settings - Check before you begin

Your computer settings:
In order to use the full functionality of the costing template, the security setting in Excel will need to be set to low. This is done as follows:
(For older versions of Microsoft Office Excel)
1. Click on the Tools menu (or Alt T), select „Macros‟ (M) to expend the Macro menu
2. Select „Security (S) from the expanded Macros menu
3. On the „Security Levels‟ tab, make sure the security setting radio button is set to „Low‟.
NB: Make a note of the original settings so you can switch back if required.
4. „OK‟ to apply the settings

(For Microsoft Office Excel 2007)
There are two ways to change the security options in Microsoft Excel 2007
Option 1:

A security warning may appear underneath your tools menu which says 'Some active content has been disabled. Click on this warning message and select the 'Enable' from the option presented.

Option 2:
1. Click the Microsoft Office Button. This button is located at the top left hand corner of the Excel window.
2. Click on the 'Excel Option' button on the bottom of the menu
3. Select 'Trust Centre' from the menu on the left
4. Click the 'Trust Centre Settings...' button (it will appear towards the bottom right of the window)
5. Select 'Macro Settings' from the menu on the left
5. Make sure the 'Enable all Macros' radio button is selected.
NB: Make a note of the original setting so you may switch back if required.
6. Click 'OK'

Some general points:
∙ All calculations will be done automatically - you do not need to do them.
∙ The formulae behind the cells are locked.
∙ The only cells which you should attempt to populate or change are the white cells; all coloured cells are locked.
∙ You must click out of the cell for the calculation to appear
∙ Right click the mouse and select 'delete' to remove data from a cell.
∙ Complex, multiple armed studies will need to complete a separate Costing Template for each arm. Organising the various arms can be done by saving the Costing Template file with a unique
identifier (e.g., ACME_Pharma._Acute_Myeloctic_Leukemia_Arm_1, etc.)

The Study Information Page
This pages allows you to capture information about the study to be used in the templates calculations.
1. Start by completing the study information that helps you identify your study, the site involved and research team for this costing

2. Select the NHS Trust that relates to you study site. The Template will automatically provide the Trust's Payment by Results Market Forces Factor to use its calculations.

3. Then input the duration of the study in months (for core activities), then include the number participants that will be recruited for this site.



The Per Patient Budget Page

This page is divided into two sections, the Procedures section and the Investigations section. The page auto calculates the per patient budget using benchmarked prices for Investigations and
the following staff hourly rates which are INCLUSIVE of overheads and capacity building:
       Clinical Staff: £124.00
       Nurse Staff: £43.43
       Pharmacy Staff: £43.43
       Practice manager: £43.43
       Administrative/ Data mgmt Staff: £20.06
       Several staff rates have been tethered to equivalent NHS Agenda for Change pay bands in order to have a consistent methodology for the Primary Care Costing Template. This
       approach was chosen given the variability and lack of transparency of staff pay in general medicine.

How to complete the Procedures / staff activities section:

1. Check that the visit boxes across the top of the template reflect the visit names in the protocol. (e.g., there may be a Screening or Washout Visit prior to visit 1) and alter the visit names
appropriately

2. If you require more visits than the number displayed, click the Add Extra Visits Column button

3. To insert a procedure, click on the drop down box and select an activity.

4. To insert this activity, click the Insert Procedure to List button. If an activity you require is not listed, simply click on an empty cell and type in the activity you require.

5. The time required for this activity should be in line with the protocol and any local considerations.

6. Identify at which visits each activity will occur and enter the number of times the activity will take place. This will nearly always be 1. It is important to enter a number in these boxes (not a tick or
cross).

7. If you require more rows click the Add Procedure Row button

8. As you complete each line you will find that the Template auto-calculate the total staff costs for each activity (horizontally).

9. When you finish entering the activities, you will find that the Template auto calculates the total staff costs per visit (vertically).

How to complete the Investigations section:

1. The Investigations column captures all research investigations and procedures that will take place in other departments which are not dependant on research staff time.

2. To insert an investigation, click on the drop down box and select an activity.

3. To insert this activity, click the Insert Investigations to List button. If an activity you require is not listed, simply click on an empty cell and type in the activity you require.


4. The Insert Selected Investigation button will automatically enter the investigation and the price into the Investigations box on the Per Patient Budget page. The price of each Investigation
already INCLUDES overheads; the template will automatically add a capacity building fee of 20%.

5. Identify the visit that each investigation takes place at and enter the number of times it occurs. As with the staff activity, this will nearly always be 1.


6. You will note that when you have completed the investigation information, the Template will auto-calculate the total cost per visit for both staff activity and Investigations and also the total price.

7. If the investigation you require is not listed, you can enter it as free text in an empty cell under the investigations section of the Per Patient Budget page

You should now have the total fee per patient. This fee will be adjusted for each individual site using the Payment by Results Market Forces Factor (PbR MFF) multiplier to allow for
geographical variations in cost. The Payment by Results Market Forces Factor multiplier can only be added when individual NHS Trusts have been identified.


How to add the PbR MFF :

1. To include a Trust's PbR MFF go to the Study Info tab. From the drop down list, select and click on the Trust for the site you will be working with.

2. The Trust name will appear on the Per Patient Budget page and the PbR MFF for that Trust will be automatically entered and the final price per patient for that individual NHS Trust will be
calculated.

3. The PbR MFF will also appear on the Pharmacy page and the Summary page.

4. The Template can be saved locally with prices for individual NHS Trusts. Additionally, if there is no specific Trust in mind, then the Template can be saved with a Blank field to be determined
later.




The Pharmacy Page
The Study Information question on pharmacy will indicate whether or not you need to complete this section. If you marked yes to the question stating that you'll need to complete the pharmacy
section then you'll need to follow the steps below. In all other events, you'll need to discuss the costs of drug management for the study with the Practice. This cost should be included along with
the activities documented in this tool.

The Pharmacy page is divided into four sections; Activity Costed Per Patient , Set Up and Closedown Fees, Trial Maintenance Fees and Other Pharmacy Services . Prices are
calculated using an hourly staff rate of £53.76 which is INCLUSIVE of overheads and capacity building.

Activities Costed Per Patient section:
This section covers pharmacy activities costed per patient – dispensing and/or aseptic dispensing (aseptic compounding)
1. Complete details of the total number of patients expected to be recruited into the study and the number of dispensing episodes required for each patient and the number of visits requiring
dispensing

2. If the protocol specifies that pharmacy staffs are responsible for arranging posting and courier services of IMP/NIMPs, then place a "tick" in the check box for “Posting IMP.”

3. Complete details of any aseptic dispensing activities required. Decide whether the study involves any aseptic handling or reconstitution to be performed by the pharmacy. If yes, enter how
many dispensing episodes will occur per patient in the “Number of agents requiring aseptic compounding” section.

4. If returns are to be counted and recorded on accountability forms then enter a “tick” in the check box for “Medicine Reconciliation.”



Set Up and Close Down Fees section:
Simply chose the appropriate a set up fee.
-    If a simple dispensary-only type study with no aseptic handling required, choose A
-    If the study involves only has only aseptic dispensing handling and no involvement of dispensary staff dispensing choose B
-    If the study requires involves both dispensary staff and aseptic handling dispensing choose C



Maintenance Activities section:
1. If your study requires any one or more of the activities listed in this section then enter a “tick” in the check box for this activity. If the management of trial stock will occur of a short or longer
period than the planned study duration than change the study duration period here.
-      This fee is non-negotiable – the activities listed will not be considered separately
Other Pharmacy services section:
The need for or extent of several activities may be difficult to predict or cost accurately pre-trial, nevertheless, these activities are likely to occur during the course of the study. These activities
have been listed as a separate section and will be invoiced to the company if and when they occur. These terms under which these activities will be costed at the Primary Care Costing Template
rate of £56.91 per hour plus the applicable PbR MFF or as otherwise listed. This information should be included with the other financial arrangement under Appendix 5 of the model Clinical Trial
Agreement.

1. If your study is predicted to have a large recruitment or a lot of IMP to store and thereby needing space of more than approx 0.5m2, consider the storage space option you should add the
storage charge

2. Waste – if the Trust is expected to dispose of any IMP waste, include this in this section




NHS Research and Development Management and Other Costs Page
The NHS R&D Fee is a recommended fee but may be subject to negotiation with individual NHS Trusts.

Refreshments

Patients requiring visits of more than 3 hours should be offered suitable refreshments. This could include drinks, a light snack or a meal whichever is the most appropriate. Refreshments should
also be available for carers if the patient need to be accompanied.


How to estimate Patient Travel Costs

It is very difficult to predict costs for patient travel. Companies should decide a maximum amount per patient per visit. Any potential patients liable to exceed this figure can be discussed with the
company. NHS Staff should collect and retain all travel receipts or evidence of mileage during the study. These costs are not captured in the Summary page as it is not possible to calculate the
total travel costs per patient.


Archiving
The cost of storage of study documents should be agreed at the beginning of a study. Companies should be able to estimate the amount of storage that will be required if the site meets the
patient recruitment target.

Screening
Companies may wish to propose a fee for screening potential patients which directly relates to the number of patients recruited into the study. This will ensure the site is appropriately reimbursed
but will ensure that the remuneration is linked to patient accrual.

Additional Itemised Costs
In the course of negotiations with Trusts, if any additional costs unique to the study emerge then these can be captured and included within this section.




Summary Page
This page automatically collates all the prices from other pages.




Complete list for the Investigations Pricing Index
An important element of the NIHR CRN Costing Programme is the Investigation Pricing Index which has been developed to capture the research investigations commonly used in Industry
studies. More than twenty-five Provider to Provider data-sets from NHS organisations were collected through the NIHR Comprehensive Local Research Networks; these data contain the prices
that the NHS host organisation charges another NHS organisation for a specific investigation. Any outlying data points were removed by subtracting any prices greater than one standard
deviation from the mean and the PbR MFF was removed from each individual Trust price. These data were then used to establish a mean cost for each investigation. The prices will have 20%
capacity building added by the Primary Care Costing Template but overheads will NOT be added as they have already been included by Trusts. The PbR MFF multiplier will also be used for
Investigations.

This exercised highlighted the variability in prices, expertise and efficiencies and in the delivery of many NHS services. As a result, were service prices were centred around a mean these
activities were standardised according to the process above. Where activities were too variable to standardise these activities have been listed without a price.


A complete list of standardised activities and their definitions can be found below.
click here to see standardised list
                                The NIHR CRN Costing Programme

                                the NIHR CRN has been leading on a Costing Project to develop a clear and transparent process which will provide industry and the NHS with a consistent method of costing industry contract
                                research carried out within the NIHR Networks. Attention has focussed on contract trials of pharmaceutical and biotechnology products conducted in secondary care, which is the focus of this
                                document. Following from the success of the Industry Costing Template, additional templates suitable for use in primary care and in studies of medical devices have been developed.

                                This work has been developed on behalf of the NIHR and addresses a specific recommendation made in the Cooksey Report, which highlighted the need for a transparent and consistent
                                national costing system. Although developed primarily for the facilitation of studies managed via the NIHR Networks, the methodology is also freely available to companies intending to run trials
                                outside of the Networks


                                The UK tends to be more expensive than the rest of Europe for conducting industry-sponsored studies and this can be partially attributed to the recognised higher cost of living. However, this
                                does not account for the widely varying cost of conducting a study throughout the UK and the inconsistent and non-transparent methods used to calculate commercial prices. In some cases,
                                NHS Trusts may not be properly reimbursed for the services provided to Industry whereas other NHS Trusts demand unrealistically high fees. This variability in prices, especially for multi-centre
                                studies, linked with unreliable delivery of patients and their data, is identified by industry as a significant factor in explaining why the UK is not seen by some as a cost-effective place to conduct
                                later phase clinical trials.

                                The Industry Costing Template:
                                            Provides a clear, consistent methodology and transparent prices for both the NHS and Industry
                                            Ensures that the NHS is fully reimbursed for commercial research activities in accordance with operating and financial requirements
                                            Indentifies standard rates for research activities that are both common and differing across the whole of the NHS
                                            Creates a focused negotiating framework to facilitate timely and accurate study costings
                                            Supplements all costing activities with clear guidance and support
                                            Ensures that costing process and negotiations can be implemented through the NIHR networks


                                The NIHR CRN Costing Programme is lead by the NIHR CRN Road Map Group. The NIHR CRN Industry Costing Group and the NIHR CRN Pharmacy Advisory Group consult, develop and
                                provide guidance on the templates use with the NIHR CRN.




                                How to contact the NIHR CRN with a costing query
                                To ask a question regarding a study cost, a study negotiation or any issues related to the template's use, please send an email to the "help" address:
                                crncc.costinghelp@nihr.ac.uk

                                To feedback any improvements or considerations regarding the template, please send an email to the "feedback" address:
                                crncc.costingfeedback@nihr.ac.uk


                                How to arrange training
                                to arrange training on the use of any of the NIHR CRN costing templates, please send any email to the costing feedback address, crncc.costingfeedback@nihr.ac.uk. Please include your
                                contact details and information on you next training event.

Standardised Investigations Pricing Index:
ACTIVITY                        DEFINITION                                                                                                                                                                                                                         PRICE
24 hour Cardio memo/ cardio     Electrocardiographic monitoring for 24 hours by continuous computerized monitoring and non-continuous recording, and real-time data analysis utilizing a device capable of producing intermittent full-sized waveform
diary                           tracings, possibly patient activated; includes monitoring and real-time data analysis with report, physician review and interpretation                                                                                                £113.86
24 hour Holter monitoring       Electrocardiographic monitoring for 24 hours by continuous original ECG waveform recording and storage, holter monitoring: Includes hook-up, recording, scanning analysis with report, physician review and interpretation,
with interpretation             each 24 hours                                                                                                                                                                                                                         £94.88
24 hour Holter monitoring       Electrocardiographic monitoring for 24 hours by continuous original ECG waveform recording and storage, holter monitoring; recording which includes hook-up, recording, and disconnection, each 24 hours                              £38.95
Biochemistry A                  ALT, Amylase, Chloride, CRP, Creatinine Kinase, Glucose, Iron, Magnesium, Oestradiol, Osmolality, Triglycerides, Uric Acid                                                                                                             £7.02
Biochemistry B                  Bicarbonate (Total CO2), CA125, Ca15-3, CA19-9, CEA, Cholesterol, Creatinine Clearance, CRP, Direct Bilirubin, Electrophoresis (EPS), Faecal occult blood, Free T4, hCG, HDL-Cholesterol, Human Growth Hormone (HGH), LH, T3,
                                T4, U&E, UFC                                                                                                                                                                                                                           £9.74
Biochemistry C                  beta 2 microglobulin, BNP, Serum Electrophoresis (EPS), FSH, IGF-1, Immunofixation - serum or urine, Immunoglobulins (A,G,M), Paraprotein measurement (Densitometry), Progesterone, PSA, Prolactin, Testosterone, TGB,
                                Thyroglobulin/TG auto Ab, Total T3, Transferrin/TIBC, TSH                                                                                                                                                                             £13.82
Biochemistry Profile - Basic    Basic Biochemistry Profile: Includes ALT, Alkaline phosphatase, Bilirubin (Total), Calcium, Carbon dioxide, Chloride, Creatinine, Glucose, Potassium, Phosphate, Sodium, Urea, Nitrogen (BUN)                                         £14.98
Biochemistry Profile - Full     Full Biochemistry Profile: Includes Albumin, Bilirubin (total), Calcium, Carbon Dioxide (bicarbonate), Chloride, Creatinine, Glucose, Alkaline Phosphatase, Potassium, Protein, Sodium, Alanine Amino Transferase, (ALT) (SGPT),
                                Aspartate AminoTransferase, (AST) (SGOT), Urea, Nitrogen (BUN)                                                                                                                                                                         £19.98
Biochemistry Profile - Lipid    Biochemistry Lipid Panel: Includes Total Cholesterol, Lipoprotein, high density cholesterol, cholesterol (HDL cholesterol), Triglycerides,                                                                                              £9.99
Biochemistry Profile - Liver    Biochemistry Liver Function Test: Includes Albumin, Bilirubin, Phosphatase, Alkaline, Protein, total, Transferase, Alanine amino Transferase (ALT) (SGPT), Aspartate amino transferase (AST) (SGOT) ,                                   £9.99
Biochemistry Profile -          Biochemistry Thyroid panel, thyroid function tests - Includes triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH)                                                                                                 £27.97
Biopsy of Bone marrow           Biopsy of Bone marrow, by trocar or needle: Includes preoperative care (including a medical history and physical examination), anaesthesia and typical postoperative care and reporting                                                £49.94
Biopsy of muscle                Biopsy of muscle: Includes preoperative care (including a medical history and physical examination), anaesthesia and typical postoperative care.                                                                                      £184.94
Biopsy of skin                  Biopsy of skin, subcutaneous tissue and/or mucous membrane, skin tumour: Includes preoperative care (including a medical history and physical examination), anaesthesia and typical postoperative care.                                £47.94
Bone and/or joint imaging       Bone and/or joint imaging, bone scan, bone scintigraphy, whole body: Includes the technical and professional components (reading)                                                                                                     £184.77
Cardiac Troponin                Troponin, quantitative; Cardiac Troponin I (cTnI), Cardiac Troponin T (cTnT)                                                                                                                                                           £17.98
Central I.V. Line               Central I.V. Line                                                                                                                                                                                                                     £358.73
Copy of imaging                 Copy of imaging investigation on CD/DVD/Film                                                                                                                                                                                            £8.32
CT Scan complex with            Computerized axial tomography, (Cat Scan) (CT Scan); Complex, multi area with contrast material : Includes the technical and professional components (reading) .                                                                      £366.12
CT Scan with contrast           Computerized axial tomography, (Cat Scan) (CT Scan); with contrast material. Includes the technical and professional components (reading) .                                                                                           £224.97
CT Scan without contrast        Computerized axial tomography, (Cat Scan) (CT Scan); without contrast material. Includes the technical and professional components (reading) .                                                                                        £147.12
RECIST Premium on               Response Evaluation Criteria in Solid Tumours (RECIST) applicable criteria for measuring tumour response using X-ray, CT and MRI using this technique                                                                                 £102.23
DEXA, BM, DXA                   Dual energy x-ray absorptiometry (DEXA) (BMD) (DXA) bone density study: Includes the technical and professional components (reading)                                                                                                   £75.91
ECG no report                   Electrocardiogram, routine 12 lead ECG, Tracing only                                                                                                                                                                                   £14.98
ECG with report                 Electrocardiogram, routine 12 lead ECG includes tracing, interpretation and report                                                                                                                                                     £24.97
Endoscopy - no biopsy           Upper gastrointestinal endoscopy diagnostic including oesophagus, stomach, and either the duodenum and/or jejunum as appropriate                                                                                                      £237.71
Endoscopy - simple - no         Upper gastrointestinal endoscopy including oesophagus, stomach, and either the duodenum and/or jejunum as appropriate; simple primary examination                                                                                     £162.80
Endoscopy with biopsy           Upper gastrointestinal endoscopy including oesophagus, oesophagus, stomach, and either the duodenum and/or jejunum as appropriate; with biopsy                                                                                        £349.57
Full Blood Count                Blood count; haemogram and platelet count, haematocrit, haemoglobin, automated and manual differential WBC count (CBC), haematology, Red blood indices: Mean corpuscular volume (MCV), Mean corpuscular
                                haemoglobin (MCH), Mean corpuscular haemoglobin concentration (MCHC), Red blood cell distribution width (RDW)                                                                                                                           £9.99
Glucose test - Finger Stick     Glucose; blood, serum, reagent strip, finger stick test                                                                                                                                                                                 £4.00
GTT, OGTT                       Glucose tolerance test (GTT) (OGTT)                                                                                                                                                                                                     £7.99
Haematology A                   D Dimer, aPTT, Coombs test, Differential (manual), ESR, Fibrinogen, Iron stain, Prothrombin Time, Reticulocyte, TCT                                                                                                                     £6.53
Haematology B                   CD20, CD4, Clotting screen for line insertion, T Cell Count, TTC Code: Prothrombin time (PT) and Thromboplastin time, partial (PTT) (aPTT) combined                                                                                    £16.50
Hepatitis C antibody            Hepatitis C antibody (HCVab) (anti-HCV)                                                                                                                                                                                                £19.98
INR                             International Normalised Ratio (INR)                                                                                                                                                                                                    £8.99
IVUS                            Intravascular ultrasound (non-coronary vessel) during diagnostic evaluation and/or therapeutic intervention (IVUS)                                                                                                                    £167.56
Microbiology A                  Microbiology A, Chlamydia serology, Genital swab, Hep B vaccine Ab status, Legionella Ab, Rubella clinical, serology non-viral (syphilis), throat swab, Toxoplasma Ab, Urine culture (incl germ tube test), Viral Ab screen
                                                                                                                                                                                                                                                                        £9.10
Microbiology B                  ASO, Cl. Difficile, Hep A, Hep C screen, HIV, other bacteriology (incl mycology), Wound swab                                                                                                                                           £10.48
Microbiology C                  Antibiotic assay, Blood culture, Chlamydia detection, Faeces, Sputum, TB Culture                                                                                                                                                       £14.83
MRI more than one area with     Magnetic resonance imaging, (MRI); with contrast material(s) more than one area (e.g. chest & abdo, abdo & pelvis). Includes the technical and professional components (reading)                                                      £556.01
MRI single area with            Magnetic resonance imaging, (MRI); with contrast material(s) single area (e.g. extremities, joints, chest, brain, orbit, face). Includes the technical and professional components (reading)                                          £429.14
MRI single area, no contrast    Magnetic resonance imaging (MRI); single area e.g. extremities, joints, chest, brain without contrast material(s): Includes the technical and professional components (reading)                                                       £353.73
MUGA RNV                        Cardiac blood pool imaging, radionuclide ventriculography, left ventricular ejection fraction (LVEF) (RNV) (MUGA), single study at rest or stress: Includes the technical and professional components (reading)                       £146.36
Overnight Stay                  Overnight stay at clinical research site. Includes periodic monitoring and attendance by health care professionals                                                                                                                    £373.67
Pregnancy test (blood)          Serum pregnancy, chorionic gonadotropin (HCG) (BetahCG); quantitative                                                                                                                                                                   £9.99
Pregnancy test (urine)          Urine pregnancy, chorionic gonadotropin (hCG) (BetahCG); qualitative                                                                                                                                                                    £7.67
Transthoracic ECHO              Echocardiography, transthoracic, real-time with image documentation (2D) with or without M-mode recording                                                                                                                             £160.80
UDS                             Urine Drug screen (UDS)                                                                                                                                                                                                                £29.96
Ultrasound 1with report         Ultrasound, (echography) (uls); B-scan: chest, extremities, non-vascular, soft tissues (head & neck). Includes the technical and professional components (reading)                                                                     £54.93
Ultrasound 2 with report        Ultrasound, retroperitoneal (e.g., renal, aorta, kidney, spleen, gallbladder) (echography) (uls); peripheral vascular system real time with image documentation. Includes the technical and professional components (reading).
                                                                                                                                                                                                                                                                       £79.90
Ultrasound 3 with report        Ultrasound, transrectal, prostate (echography) (uls). Includes the technical and professional components (reading)                                                                                                                    £119.85
Ultrasound 4 with report        Ultrasound, transvaginal, vaginal probe ultrasonography (TVUS) (echography) (uls): Includes the technical and professional components (reading)                                                                                        £54.93
Urinalysis                      Urinalysis, by dip stick or tablet reagent for bilirubin, glucose haemoglobin, ketones, leukocytes, nitrite gravity, urobilinogen (urine analysis) (UA); without microscopy                                                            £16.05
X-ray multiple views with       Radiologic examination, (X-Ray); multiple views. Includes the technical and professional components (reading)                                                                                                                          £29.96
X-ray single view with report   Radiologic examination, (X-Ray); single view. Includes the technical and professional components (reading)                                                                                                                             £21.97
X-ray -spine or bone with       Radiologic examination (X-Ray); spine or bone survey. Includes the technical and professional components (reading)                                                                                                                     £49.94

				
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