National Cancer Institute
National Cancer Institute U.S. National Institutes of Health

Standardization Initiatives

Transformation of the cancer clinical trials system into an efficient enterprise that produces quality results in a timely manner hinges on standardization of critical tools and procedures, by:

  • Creating an interoperable information technology platform
  • Developing commonly accepted Common Data Elements and standard Case Report Forms
  • Instituting a widely recognized credentialing system for research personnel and sites

Significant time savings would also be achieved by adopting standard contractual language that minimizes the need for recurrent intellectual property, confidentiality, and other negotiations.

Standardization in each of these key areas will speed the initiation and conduct of clinical trials, minimize duplication, and ultimately result in a faster, more efficient clinical trials system. To achieve this improved standardization, the CTWG proposed four initiatives; three of which are new, and one that offers significant enhancements of current NCI activities.

For full details on the initiatives, see the CTWG Report (PDF - 366KB).

The CTWG Standardization Initiatives

Initiative 1: Promote establishment of national clinical trial information technology infrastructures that are fully interoperable with NCI’s cancer Bioinformatics Grid.

Initiative 2: Achieve industry and FDA concurrence on standard Case Report Forms incorporating Common Data Elements.

Initiative 3: Develop a credentialing system for investigators and sites that is recognized and accepted by NCI, industry sponsors, clinical investigators, and clinical trial sites.

Initiative 4: Establish commonly accepted clauses for clinical trial contracts.

Standardization Initiatives—Key Accomplishments