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Commercial study validation checks

 

Contents

What is the interactive Costing Tool Validation?

The CRN validation is a check that all protocol required procedures, investigations and tasks defined in the latest Protocol Schedule of Events and attached as part of the Study Resource Review submission, are included in the NIHR CRN Interactive Costing Tool (iCT).

The validation itself does not consider the time value or standard of care status allocated to any study activities; this is the responsibility of each participating organisation to assess. This information is required in order to generate a price for each activity, and therefore participating site, via the standardised costing methodology for commercial contract research in the health and care system.

How is a validation requested?

In order for a validation of the iCT to be completed, the company representative will need to request the Study Resource Review via a Feasibility Services request within the Central Portfolio Management System (CPMS).

View an infographic outlining the various stakeholders involved and actions taken in completion of the iCT and Study Resource Review process.

What information is needed to enable the validation?

During this submission the company representative will be asked to provide the following information in order for a review to be conducted:

  • IRAS/study identifier number and/or title for identification
  • Chief Investigator name and location (where known) for reviewer allocation
  • Sponsor/ CRO contact details for feedback provision
  • Protocol/Schedule of Events to inform review
  • Protocol number/version to confirm version used for check.

Based on this information, the NIHR CRN will allocate the submission to a validator, ideally in the Local CRN where the Chief Investigator is located, and monitor the timescales of requests, ensuring that a validation using the Study Resource Review in CPMS will be performed in an accurate and timely manner.

What is validated?

During the Study Resource Review the Local CRN will review the following information to ensure that activities required to deliver the study have been appropriately added as items within the iCT:

CPMS Data

The validating officer will view the Study Resource Review submission in CPMS, to ensure functionality is maintained and all inputs and data are visible

Completion status

The validating officer will ensure that the submitted service has been populated with the minimum study specific information to validate.

Where no information has been included within the tool i.e. the tables are blank or have minimal content that is disproportionate to the study requirements, the nominated company representative on the submission will be contacted directly to signpost to the available national guidance and support to complete and understand the tool. This may also result in the service being reverted for resubmission at a later date.

Sponsor/ CRO Contact details in CPMS

The validating officer will ensure that Sponsor/ CRO contact details (name and email or telephone) have been included or highlight requirements for Sponsor/ CRO to include prior to sharing with the sites.

Study Information Section

The validating officer will check that the Sponsor/ CRO has completed the submission as fully as possible for the study e.g. study information section and additional questions/ comments (if applicable).

This includes all additional information, as necessary, in the protocol/schedule of events or other provided information and should be uploaded within the attachment tab of either the CPMS study record or the submission itself.

Scheduled Activity

The validating officer will check the following against the study protocol:

  • The number of visits and arms (e.g. long term follow-up) included and named as per the protocol/schedule of events. For multiple arms, additional arms should be displayed within the iCT
  • That 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
  • That all line items have times or prices values assigned
  • That the 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/comments 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 or setup and closedown sections)
  • 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.

Unscheduled Activity

The validating officer will check the following against the study protocol:

  • That any activities which may occur at unscheduled time points are included (e.g. extra lab tests or unscheduled x-rays)
  • That 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)
  • That 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 Activity

The validating officer will check:

  • All per patient study drug and comparator activity have a corresponding entry within the ‘per patient’ section
  • Number of visits for dispensing is correct for per patient section.

Study Arms

The validating officer will check that confirmed totals are displayed from the individual sheets.

When is validation completed?

Upon completion the validating officer will ensure:

  • That any changes are fully commented upon and that a comment flag appears within the iCT to denote that a change and comment has been made
  • That the Study Resource Service ticked as 'Mark Complete' thereby closing the validation service.
  • A summary of any adjustment(s) made are detailed within a response email to the company representative, that will accompany the closure of the Study Resource Review Service in CPMS.
  • That correspondence supporting the completion of the validation process is forwarded to the company representative when notified of the completion of the validation.

Further information