Archiving and publication

The sponsor must provide a clinical trial summary report to competent authorities (MHRA in the UK) and ethics committees of all member states concerned.

Publication

The results of clinical research are disseminated to the research community, trial participants and the general public, for example through publication in peer-reviewed scientific journals. Research findings with substantial implications for clinical practice or which are likely to attract strong public interest should be drawn to the attention of the funder before publication.

Archiving research documentation

Research records need to be preserved for the longer-term for a number of reasons.  They may be needed:

  • For scientific validation of the research,
  • For future research and audit, and
  • Occasionally by patients themselves (or their treating clinicians) who may have continuing long-term concerns about their own health (for instance, where trials of novel treatments were involved).

Resources

TypeWhere to find
Key contacts Clinical DivisionsJRCO
Useful links JRCO - register on public database
NIHR Clinical Trials Toolkit - dissemination of results
NIHR Clinical Trials Toolkit - archiving
NIHR benchmark Post NIHR 70-day benchmark
Process map links This activity occurs in the recruitment stage:
Imperial College London as sponsor
Imperial College Hospital NHS Trust as sponsor
Commercial organisation as sponsor
Non-commercial organisation as sponsor