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Metrics

The Minimum Data Set (MDS) is a resource created to support the reporting requirements Research Offices (ROs), Clinical Trial Units (CTUs) and other departments that run clinical trials within health settings or academic institutions.

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 Minimum Data Set (MDS) is a resource created to support the reporting requirements of Research Offices (ROs), Clinical Trial Units (CTUs) and other departments that run clinical trials within health settings or academic institutions. Along with the Metrics and you booklet, the table below can be used to provide clinical trial benchmarks and help to determine reporting requirements, including in relation to the Australian Commission on Safety and Quality in Health Care's (ACSQHC) National Clinical Trials Governance Framework (NCTGF) and the National Aggregate Statistics (NAS).

This project is part of a larger program of work de-mystifying the National Clinical Trials Governance Framework. A partner resource, The Implementation Workbook by Melbourne Academic Centre for Health (MACH), can also be accessed using the button below.

Access workbook

This project is a work in progress. We'd love to hear how you're finding it. Provide your feedback

Minimum Data Set

Note: additional data may be collected by your state alongside the metrics below.

A glossary of search terms is available here.

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

Scientific Title

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

Acronym or Short Title

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

Trial registration # (ACTRN)

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

Trial registration # (NCT)

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

Trial registration # (Other)

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

Registration under Clinical Trial Notification Scheme (CTN)

  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Registration under Clinical Trial Approval Scheme (CTA)

  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Trial Phase (NAS Metric 1)

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
  • Cancer Census Data
  • Teletrials MDS
  • NCTGF Suggested
  • Contributory or Identifier
Site
RO or CTU

Study type

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

Trial type

  • CTU Improvement
  • Cancer Census Data
Study
CTU

Teletrial: Primary or Satellite Site

  • CTU Improvement
  • Cancer Census Data
  • Teletrials MDS
Site
RO or CTU

Teletrial format

  • Teletrials MDS
Study
RO or CTU

MMM Code

  • Cancer Census Data
  • Teletrials MDS
Site
CTU

Overall status of trial

  • CTU Improvement
  • Cancer Census Data
Study
RO or CTU

Site status

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

Major sponsor type (NAS Metric 1a)

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

Name of sponsor

  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Type(s) of funding

  • CTU Improvement
  • NCTGF Suggested
Study
RO or CTU

Funder(s) of trial

  • CTU Improvement
Site
CTU

Start date of the trial

  • Cancer Census Data
Study
CTU

End date of the trial

  • Cancer Census Data
Study
CTU

Completed hospitals

  • Cancer Census Data
Study
CTU

Not yet recruiting hospitals

  • Cancer Census Data
Study
CTU

Recruiting hospitals

  • CTU Improvement
  • Cancer Census Data
Study
CTU

Closed hospitals

  • Cancer Census Data
Study
CTU

Patient sex (as per trial eligibility criteria)

  • CTU Improvement
  • Cancer Census Data
Site
CTU

Clinical Trial Department

  • NCTGF Required
  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Site
CTU

Date selected by trial sponsor

  • CTU Improvement
Site
CTU

Disease type

  • CTU Improvement
  • Cancer Census Data
Site
CTU

Tumour type

  • CTU Improvement
  • Cancer Census Data
Site
CTU

Total anticipated recruitment for trial (NAS metric 6)

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
  • NCTGF Suggested
Study
RO or CTU

Total actual recruitment for trial (NAS Metric 6)

  • NAS Mandatory
  • NCTGF Required
  • NCTGF Suggested
Study
RO or CTU

Anticipated recruitment at site (NAS Metric 7)

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
  • Teletrials MDS
  • NCTGF Suggested
Site
RO or CTU

Actual recruitment at site (NAS metric 7)

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Total NEW participants YYYY

  • NCTGF Required
  • CTU Improvement
  • Cancer Census Data
  • NCTGF Suggested
Site
RO or CTU

Number of potential participants screened at site (Screen Failures)

  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Total FOLLOW UP patients

  • CTU Improvement
  • Cancer Census Data
Site
CTU

Time to First Patient First Visit (FPFV)

  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Site Initiation Visit

  • CTU Improvement
  • Teletrials MDS
Site
CTU

Year of birth for each NEW participant

  • CTU Improvement
  • Cancer Census Data
  • Teletrials MDS
Site
CTU

Residental postcode for each NEW participant

  • CTU Improvement
  • Cancer Census Data
  • Teletrials MDS
Site
CTU

Aboriginal/Torres Strait Islander and First Nations

  • NCTGF Required
  • CTU Improvement
Site
CTU

Culturally and Linguistically Diverse (CALD)

  • CTU Improvement
Site
CTU

Mode of HREC review

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

Low risk

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Reviewing HREC state

  • NCTGF Suggested
Site
RO or CTU

Reviewing HREC

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

HREC meeting date

  • NCTGF Suggested
Site
RO or CTU

HREC submission date

  • CTU Improvement
  • NCTGF Suggested
  • Contributory or Identifier
Study
RO or CTU

HREC validation date

  • NCTGF Suggested
  • Contributory or Identifier
Study
RO or CTU

HREC approval date

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

HREC reference number

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

SSA reference number

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

SSA submssion date

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

SSA validation date

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

SSA authorisation date

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

Derived metrics

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

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
Study
RO or CTU

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

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
Study and site
RO or CTU

HREC Approval Timeline Without Clock (NAS Metric 4a)

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

HREC Approval Timeline With Clock (NAS Metric 4b)

  • NAS Mandatory
  • NCTGF Suggested
Study
RO or CTU

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

  • NAS 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)

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

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

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

FTE on trial

  • CTU Improvement
  • NCTGF Suggested
Site
CTU

Trials cost

  • CTU Improvement
  • NCTGF Suggested
Site
CTU

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

  • NAS Mandatory
  • NCTGF Required
  • CTU Improvement
Site
RO or CTU

Clinical Incidents

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Consumer-related complaints

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Workforce-related complaints

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Incident reporting - time to complete required actions

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Sponsor and regulatory audits

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Patient and consumer experience survey

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Workforce survey

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Risk ratings

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Compliance with ICH-GCP training

  • CTU Improvement
  • NCTGF Suggested
Site
RO or CTU

Telehealth

  • CTU Improvement
  • Teletrials MDS
Site
CTU

Glossary of search terms

  • Metrics

    Depending on “who” requires the metrics, these are identified as:

    NCTGF Required – These are metrics mandated by the NCTGF.  

    NAS Mandatory – The National Aggregate Statistics (NAS) metrics are required operational metrics for clinical trials in Australian public health institutions, maintained by the Department of Health and Aged Care.

    NCTGF Suggested – These are metrics suggested by the NCTGF or mentioned in Operational Metrics Tool. These are considered as useful relative to project goals - for instance, to identify where process improvements can be made or resource allocations can be changed; to establish performance benchmarks; and/or to effectively manage workload across teams.

    CTU Improvement – These are metrics considered important when running a Clinical Trials Unit. These are helpful for business and quality improvements.

    Cancer Census Data – These are metrics collected on behalf of state and territory governments. They are used to support the evaluation of the state-based Cancer Plan(s), and/or informing national cancer programs. Data requests may be available to eternal organisations.   

    Contributory or Identifier – These are data points that contribute to other metrics and are not metrics in their own right. An example is the date of an HREC submission, or an HREC number.

    Teletrials MDS - These are metrics with specific relevance to Teletrials. Collecting these metrics can assist in the operational and strategic running of teletrials.

  • Filters

    Use the search bar and drop-down menus to filter results.

    Study or Site level – Study-level metrics are collected about the study as a whole, while site level metrics are related to the activity of the study at a particular site.

    Who reports the data RO – Research Office, CTU – Clinical Trial Unit

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