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List of industry costing template validation checks for companies

 

Contents

version 26 July 2016

Introduction

The validation of the industry costing template will:

  • check that all protocol required procedures, investigations and tasks are included
  • not consider the price, time value or standard of care status allocated to any study activities, this is the responsibility of each study site to assess.

The information required to conduct review is:

  • IRAS/study identifier number and/or Title for identification
  • Chief Investigator name and location (where known) for template validator allocation in the relevant Local CRN
  • Sponsor contact details on the coversheet of the template to for provision of feedback
  • Protocol/Schedule of Events (including the protocol number/version) to inform review

The validation checks undertaken by our Local Clinical Research Network team

Review Validation Check
File format View file in Microsoft Excel to ensure functionality is maintained and all inputs are visible
Completion status The submitted template has been populated with some study specific information to validate. Where no information has been included within the template i.e. the template is blank or has minimal content that is disproportionate to the study requirements
  • (validation pre-HRA application) the Sponsor should be contacted directly to signpost to the available national guidance and support to complete and understand the template
  • (validation post HRA Approval application) the HRA should be contacted to signpost the company to the available national guidance and support to complete and understand the template prior to HRA approval submission
Sponsor Contact details Ensure Sponsor contact details (name and email or telephone) have been included or highlight requirement for Sponsor to include prior to sharing with the sites.
Version used The relevant template has been completed for the study e.g. drug/device and secondary/primary care template Confirm the latest template version is being used by cross checking the master template on the NIHR websiteNOTE: Occasionally, the release of a new template may overlap with submission resulting in the Sponsor initially completing a superseded version. For the purpose of the validation, the most recent version of the template should be used to reflect the Version 26JUL2016 Page 2 of 3 latest costs. Sponsors who contact and engage with the CRN early on should be made aware of the most recent version and update cycles, which adds value by avoiding rework later on.
Study Info Worksheet Has the Sponsor completed as fully as possible for the study i.e. study information section and additional questions? Include additional information as necessary when available in the protocol/schedule of events or other provided information. The Market Forces Factor (MFF) should be selected as
  •  ‘blank’ if the costing template will be used on study with multiple (two or more) research sites.
  • The participating NHS organisation for the single centre studies (or closest geographically if conducted in primary care)
Per Patient Budget Worksheet
  • Number of visits and arms (e.g. long term follow-up) included and named as per the protocol/schedule of events. For multiple arms this may be separated out into individual costing templates
  • All tasks are included as required in the sections for procedures (time based activities) and investigations (activities including a combination of equipment and staff time) ideally reflecting the terminology and order of the protocol schedule of events
  • All line items have times or prices values assigned
  • Correct activities and number of activities (E.g. 2 x vital signs or PK sampling) included for the correct corresponding visits.
  • Review of any footnotes or associated narrative within the schedule of events which can affect the information included.
  • If possible from the schedule of events, identify any grouped or multi activities named as one procedure e.g. multiple questionnaires or multiple vital signs before, during and after infusions. Include as separate procedures as required.
  • Postage and packaging line item if requirement is detailed or implied in the schedule of events e.g. for returning of diaries or information sheets
  • Any overnight stays if identified from schedule of events
  • CRF/eCRF completion or transcription time with CRF sign off (which may be a different line item if performed by another staff role)
  • Monitoring visits (may alternatively be included in the additional itemised cost section)
  • Sample preparation/blood sample preparation e.g. for central analysis
  • Provision of instructions, user training, transcription and review of any patient diaries (including e-diaries) or questionnaires
Additional Itemised Costs Worksheet
  • Any activities which may occur at unscheduled time points are included (e.g. extra lab tests or unscheduled x-rays)
  • Safety reports and AE/SAEs tasks (time and staff allocation should be left blank as it will be dependent on complexity/nature of the study and is for the sites to negotiate) Version 26JUL2016 Page 3 of 3
  • Monitoring visit support time (also may be included in the per patient section)
  • (If applicable for the study) Pre-screening procedures and investigations involving the study participants (also may be included in the per patient section)
Pharmacy Worksheet (where applicable)
  • A set-up category has been selected
  • An IMP management cost has been included
  • All study drugs and comparators have a corresponding per patient section
  • Number of visits for dispensing is correct for per patient section
Supply or Device Management (where applicable)
  • A set-up category has been selected
  • An IMP management cost has been included
Set-up and Other Costs Worksheet
  • Confirm an R&D set-up fee and training are included
  • Archiving is included unless Sponsor confirmed as responsible
  • If refreshment costs are relevant for study visits (i.e. prior fasting or lengthy duration), a value is included
  • Where the use of Primary Care Patient Referral Centres have been communicated by the Sponsor/HRA (as per IRAS form) a value is included 
Summary sheet Confirm totals are displayed from the individual sheets
Formula error  Check for any error messages within formula cells and correct, signpost to template user guidance (e.g. step by step guide) or highlight for attention during site review
Completion Ensure any changes are highlighted in yellow with description comments inserted to the relevant cells as required Complete validation outcome and validator details (name and email or phone) on Cover worksheet to support discussion with Sponsor as required