Reporting, dissemination and archiving

The whole point of research is to generate new knowledge, but unless that knowledge is shared, it has little use. You need to have made plans for how you will disseminate the results of your research as you develop your proposal.

This is not just about writing peer-reviewed papers for academic journals, but also making sure that any reporting and dissemination plan incorporates feedback to your recruiting sites and PICs, the NHS host organisations and your research participants. These groups have all had input into the research will want to know what the results of the research were. Different audiences need you to explain it in different ways.

You should also make a real effort to disseminate the research findings to the lay population: they have probably been involved at some point in the development and conduct of the research and so they also will want to know how it all turns out. Your PPIRes contact will be able to help and advise

The more you feedback to all these interested parties, the more likely they are to be happy to be involved in your next research project.
You must also ensure that you notify the R&D office at REC that you have completed your study and provide a final report (please see Progress Reporting Section for more details).

Archiving of study documentation

The archiving requirements of your study will vary depending on the type and nature of your study. You should have determined before you start your project what your archiving needs will be and have made arrangements for this. Any costs in relation to study archiving should have been incorporated into your funding application.
You should have discussed any data storage and archiving needs with your research sites when they were selected for the study so that this does not come as a surprise to them at the end of the study. It is usual for sites to retain as a minimum:

• All participant identifiable information (e.g. consent forms, code lists for pseudoanonymised data)
• Protocol
• All relevant approval letters including REC favourable opinion and NHS Permission Letter

The guidelines on retention periods for essential documents and source data (i.e. medical notes, X-rays and other material pertaining to the direct care of the participant) vary depending on the type of project you are taking part in. Please note that these are MINIMUM retention periods, and the documents may need to be stored for longer than this depending on the requirements of the Investigator, Sponsor or regulatory authorities.

For clinical trials on Investigational medicinal products (CTIMPS), i.e. those falling under the EU Clinical Trials Directive
The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least 5 years after its completion. They shall retain the documents for a longer period where so required by other applicable requirements or by an agreement between the Sponsor and the investigator.
EU GCP Directive 2005/28/EC, Article 17

For trials which do not come under the EU Clinical Trials Directive
Essential documents of the Sponsor/trial organisers and investigators, from trials that are not to be used in regulatory submissions, should be retained for at least five years after completion of the trial. These documents should be retained for a longer period if required by the applicable regulatory requirement(s), the Sponsor or the funder of the trial.
Clinical Trial Toolkit - Archiving of Documents

Other projects

It is recommended that the research records of other projects falling outside the above categories are retained for a minimum of 5 years.

Retention of Health Records

The health records of research subjects must be retained for at least 30 years as specified in the Records Management: NHS Code of Practice - Annex D1 relates to the retention periods for research related health records.

A health record is:

A single record with a unique identifier containing information relating to the physical or mental health of a given patient who can be identified from that information and which has been recorded by, or on behalf of, a health professional, in connection with the care of that patient. This may comprise text, sound, image and/or paper and must contain sufficient information to support the diagnosis, justify the treatment and facilitate the ongoing care of the patient to whom it refers.
Records Management: NHS Code of Practice - Part 1 Glossary, 05 April 2006

Archiving of Electronic Documents

If documents are to be stored electronically long term, consideration must be made of the format in which the data is stored to ensure that this remains readable. Your IT department will be able to advise you on the best format to use.

Destruction of Records

The destruction and reasons for destruction of essential documents should be documented and signed by a person with appropriate authority. This record should be retained for a further 5 years from the date that the essential documents were destroyed.
The Sponsor/someone on behalf of the Sponsor should notify investigators in writing when their trial records can be destroyed.
Clinical Trial Toolkit - Archiving of Documents