Compliance with the regulations | Archiving

Archiving

At the end of the trial – what to do with the trial records

During the course of research, all records are the responsibility of the Principal Investigator and must be kept in secure conditions. When the research trial is complete, it is a requirement of the Research Governance Framework and Trust Policy that the records are kept for a further 20 years. For trials involving Trust patients or undertaken by Trust staff, the approved repository for this long-term storage is the Trust Modern Records Centre which is based at 9 Prescot Street. More information is available from the Trust intranet site under "Records Management".

Which records should be stored?

All records relating to the trial should be stored together, including the Principal Investigator’s documentation, patient case report forms (CRFs) and any files held by Pharmacy relating to the trial. It is the responsibility of the Principal Investigator to ensure a full set of records is collated and documented (including the Pharmacy file, if one exists). More guidance on specific documents to be included can be obtained from the Modern Records Manager.

When should the records be sent for storage?

As soon as possible after the trial is fully completed and the records are no longer needed for reference.

What is the procedure for sending records for storage?

In the first instance please refer to the Trust Intranet Site under “Records Management” for transfer forms, box order forms and guidance. If you are not able to access the Trust intranet, contact the Records Management team on tel 020 7480 4866.

Records must be packed into Records Centre boxes which can be purchased from the Records Centre for £2. Unfortunately we cannot accept any other boxes due to space and health and safety requirements.

The contents of each box should be listed on our transfer form including the full name of each trial, the principal investigator, the sponsor, the covering dates of the trial and the types of records in the box.

Once the records have been taken in to the Records Centre they will be processed and a receipt will be provided back to the creating department.

Requesting records back from the Records Centre

Records can be requested from the Records Centre by emailing Sarah Coombs or Catherine Redfern and giving details of the files required ie. file title, covering dates, and box number (if known). It is preferable that you phone the department on the below phone number.

What happens at the end of 20 years?

At the end of the 20 year retention period, the Records Management team will alert R&D that the records are due for disposal. The Principal Investigator and sponsor will be informed and the full agreement of everyone concerned will be obtained before any records are destroyed.

Contacts and guidelines

Sarah Coombs, Assistant Records Manager or Catherine Redfern, Modern Records Manager, tel 020 7480 4866.

To email, use the format: firstname.lastname@bartsandthelondon.nhs.uk

Download Research records guidance.