Metrics

Clinical trial metrics are data points that provide insight into operational performance. They are powerful tools for assessing progress, decision-making, and measuring the strength of evidence used in clinical trials. The below table has been designed to support Research Offices (ROs), Clinical Trial Units (CTUs), and other departments that run clinical trials within health settings or academic institutions.

Leveraging the National Clinical Trials Governance Framework, our Minimum Data Set resource and Metrics and You booklet provides a benchmark to help Clinical Trial Units and departments determine their reporting requirements.

This resource is a work in progress. We'd love to hear how you're finding it.

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Metric
Category
Who requires the data?
Study or Site level?
Who reports the data?

Scientific Title

Trial Information
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Acronym or Short Title

Trial Information
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Trial registration # (ACTRN)

Trial Information
  • Cancer Census Data
  • Contributory or Identifier
Site
RO or CTU

Trial registration # (NCT)

Trial Information
  • Cancer Census Data
  • Contributory or Identifier
Site
RO or CTU

Trial registration # (Other)

Trial Information
  • Cancer Census Data
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Registration under Clinical Trial Notification Scheme (CTN)

Trial Information
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Registration under Clinical Trial Approval Scheme (CTA)

Trial Information
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Phase (Metric 1)

Trial Information
  • NCTGF Mandatory
  • CTU Improvement
  • Cancer Census Data
  • Teletrials / RTN Vic
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Study type

Trial Information
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Trial type

Trial Information
  • Cancer Census Data
Site
RO or CTU

Teletrial: Primary or Satellite Site

Trial Information
  • CTU Improvement
  • Cancer Census Data
  • Teletrials / RTN Vic
Site
RO or CTU

Teletrial format

Trial Information
  • Teletrials / RTN Vic
Study
RO or CTU

MMM Code

Trial Information
  • Teletrials / RTN Vic
Site
CTU

Overall status of trial

Trial Information
  • CTU Improvement
  • Cancer Census Data
Study
RO or CTU

Site status

Trial Information
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
Site
RO or CTU

Common Scientific Outcome (CSO) category

Trial Information
  • CTU Improvement
  • Cancer Census Data
Study
CTU

Major sponsor type (Metric 1)

Trial Information
  • NCTGF Mandatory
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
Site
RO or CTU

Name of sponsor

Trial Information
  • NCTGF Mandatory
  • CTU Improvement
Site
CTU

Type(s) of funding

Trial Information
  • NCTGF Mandatory
  • CTU Improvement
Study
RO or CTU

Funder(s) of trial

Trial Information
  • CTU Improvement
Site
CTU

Start date of the trial

Trial Information
  • Cancer Census Data
Study
CTU

End date of the trial

Trial Information
  • Cancer Census Data
Study
CTU

Completed hospitals

Trial Information
  • Cancer Census Data
Study
CTU

Not yet recruiting hospitals

Trial Information
  • Cancer Census Data
Study
CTU

Recruiting hospitals

Trial Information
  • CTU Improvement
  • Cancer Census Data
Study
CTU

Closed hospitals

Trial Information
  • Cancer Census Data
Study
CTU

Patient sex (as per trial eligibility criteria)

Trial Information
  • CTU Improvement
  • Cancer Census Data
Site
CTU

Clinical Trial Department

Trial Information
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
CTU

Date selected by trial sponsor

Trial Information
  • CTU Improvement
Site
CTU

Disease type

Trial Information
  • CTU Improvement
  • Cancer Census Data
Site
CTU

Tumour type

Trial Information
  • CTU Improvement
  • Cancer Census Data
Site
CTU

Total anticipated recruitment for trial (NAS metric 6)

Recruitment
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
Study
RO or CTU

Total actual recruitment for trial (NAS Metric 6)

Recruitment
  • NCTGF Mandatory
  • NCTGF Suggested
Study
RO or CTU

Anticipated recruitment at site (NAS Metric 7)

Recruitment
  • NCTGF Mandatory
  • CTU Improvement
  • Teletrials / RTN Vic
  • NCTGF Suggested
Site
RO or CTU

Actual recruitment at site (NAS metric 7)

Recruitment
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Total NEW participants YYYY

Recruitment
  • NCTGF Mandatory
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
Site
RO or CTU

Number of potential participants screened at site (Screen Failures)

Recruitment
  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Total FOLLOW UP patients

Recruitment
  • CTU Improvement
  • Cancer Census Data
Site
CTU

Time to First Patient First Visit (FPFV)

Recruitment
  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Site Initiation Visit

Recruitment
  • CTU Improvement
  • Teletrials / RTN Vic
Site
CTU

Year of birth for each NEW participant

Recruitment
  • CTU Improvement
  • Cancer Census Data
  • Teletrials / RTN Vic
Site
CTU

Residental postcode for each NEW participant

Recruitment
  • CTU Improvement
  • Cancer Census Data
  • Teletrials / RTN Vic
Site
CTU

Aboriginal/Torres Strait Islander and First Nations

Recruitment
  • NCTGF Mandatory
  • CTU Improvement
Site
CTU

Culturally and Linguistically Diverse (CALD)

Recruitment
  • CTU Improvement
Site
CTU

Mode of HREC review

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Low risk

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Reviewing HREC state

Ethics & governance
  • NCTGF Suggested
Site
RO or CTU

Reviewing HREC

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

HREC meeting date

Ethics & governance
  • NCTGF Suggested
Site
RO or CTU

HREC submission date

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Study
RO or CTU

HREC validation date

Ethics & governance
  • NCTGF Suggested
  • Contributory or Identifier
Study
RO or CTU

HREC approval date

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

HREC reference number

Ethics & governance
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

SSA reference number

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

SSA submssion date

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

SSA validation date

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

SSA authorisation date

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Derived metrics

Ethics & governance

Overall Study Start-Up Timeline (Regulatory Timeline) – Without Clock (NAS Metric 2)

Ethics & governance
  • NCTGF Mandatory
  • CTU Improvement
Study
RO or CTU

HREC and SSA/Site Assessment Approval Timeline – With Clock (NAS Metric 3)

Ethics & governance
  • NCTGF Mandatory
  • CTU Improvement
Study and site
RO or CTU

HREC Approval Timeline Without Clock (NAS Metric 4a)

Ethics & governance
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
Study
RO or CTU

HREC Approval Timeline With Clock (NAS Metric 4b)

Ethics & governance
  • NCTGF Mandatory
  • NCTGF Suggested
Study
RO or CTU

SSA/Site Authorisation Timeline - Without Clock (5a) From HREC Approval Date/SSA Validation Date (NAS - Metric 5)

Ethics & governance
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

SSA/Site Authorisation Timeline - With Clock (5b) From HREC Approval Date/SSA Validation Date (NAS Metric 5)

Ethics & governance
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Number of trials pending site authorisation by reporting period and /or year to date

Ethics & governance
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

FTE on trial

Finance
  • NCTGF Mandatory
  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Trials cost

Finance
  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Total Inbound (internal and external) Investment Annually (FY)
Actual/Planned (NAS Metric 8)

Finance
  • NCTGF Mandatory
  • CTU Improvement
Site
RO or CTU

Clinical Incidents

Safety
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU
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