End of research study & publication

The end of a research study occurs when all procedures in the protocol have been completed for all participants including the period of ‘follow-up’. This is the time when all data collection ceases and the researcher team turn their attention to data analysis.

For industry-sponsored studies in particular, when a research study ends, ‘close-out’ visits are usually done at each research site and this signifies that the study is no longer ‘active’ at the site. The date the visit occurs is usually also regarded as the study’s end date at site.

One of the final acts of the researcher during this stage is getting their paper published in a relevant peer-reviewed journal and disseminating the findings to the participants and the wider community that may benefit from the findings in an appropriate language and format.

Close-out Activities

The following activities are the responsibility of the Chief Investigator/sponsor after completion of a study –

  • Ensure appropriate analysis of data.
  • Ensure that all activities required for Study close-out are completed and documented (including Investigational Medicinal Product(s) accountability), and copies of Essential Documents are held in the files appropriately labelled in a safe, secure and confidential manner (fire proof, water proof and accessible) for a minimum of five years (including source data, eg, patients’ medical records).
  • Ensure each research site has notified their R&D Office of the completion of the Study.
  • Submit a summary of the final report to the ethics committee and MHRA (for a clinical trial involving an investigational medicinal product) within one year of the conclusion of the research.

Dissemination & PublicationSection

Good governance includes ensuring –

  1. All those pursuing health research & social care research must open their work to critical review through the accepted scientific and professional channels, eg, publication in peer reviewed journals, conference presentations, etc.
  2. Once established, findings must be made available to those participating in the research (including relatives of deceased patients who have consented to the use of organs or tissue in the research) and to all those who could benefit from the work, through publication and/or other appropriate means in an understandable format.

Registration of Clinical Trials

Clinical trials in the United Kingdom have to be registered on a publicly accessible database as a condition of gaining a favourable opinion from ethics committees. The purpose of this condition of ethics approval is to ensure that the outcomes of clinical trials are published. The Health Research Authority supports transparency in research and is signed up to the AllTrials campaign on disseminating clinical trial data (alltrials.net).