Managing an active study

Archiving

Is this for me?

This section is relevant to you if you want to archive or destroy an archive of your teams study documents where you are…

A NuTH study team.
A NuTH Sponsored hosting location.

The following sections will explain some key concepts (e.g. Approval packs), registration and who is responsible for driving the processes in different scenarios.

Guidance is provided in the form of a Work Instruction (NJRO-GEN-WI-006 – Sponsor Approval for Archiving & Destruction), process flow-charts & email templates (listed in the sections below) and training slides. Otherwise forward any queries to the Research Archiving mailbox.

What is an ‘approval pack’?

Before any study documents can be archived (or an existing archive destroyed) the request must be approved by Sponsor, and stakeholders notified to ensure they are both aware and acknowledge (where required) the intention to archive or destroy the archive. This is known as the approval pack. Notifications to stakeholders will vary upon the scenario and will typically include notifications to CI (PI cc’d), NuTH’s Research Archivist, NuTH’s Information Governance team and Sponsor admin teams within the NJRO.

Once the approval pack has been approved and all notifications sent (and acknowledged where necessary) then it will apply to all NuTH teams and NuTH Sponsored hosting locations who need to archive (or destroy an anchive) for the specified study.

To summarise, for each study…

NuTH’s information Governance notification is required by each requesting NuTH team.

Sponsor approval is only required once.

CI notification and acknowledgement (for NuTH Sponsored studies) is only required once. For ‘other Sponsor’ studies, CI notification and acknowledgement is not required as the other Sponsor should liaise with them on your behalf..

NuTH’s Research Archivist (archive destruction only) notification and acknowledgement is only required once.

Archiving Approval Pack

The archiving approval pack requires the following approvals, notifications and acknowledgements:

Requires other Sponsor approval. They should provide the retention period and date from when it should begin. Where Sponsor are not contactable (or no longer responsive) then request approval from the study’s CI (and NuTH PI cc’d) . Where both the other Sponsor and CI & NuTH PI are not contactable (or no longer responsive) then request approval from NuTH’s NJRO Research Governance Team via the Research Archiving mailbox.

NuTH Sponsored & requested by a NuTH team:

The requesting team register their request with the Research Archiving mailbox. The process is then progressed the NJRO Sponsor admin teams.

Requires NuTH Sponsor approval

Requires the CI (and NuTH PI cc’d) to be notified of the intention to archive the study at all locations. The CI should be given about 5 weeks to acknowledge.

NuTH Sponsored & requested by a hosting location team:

The requesting team register their request with the Research Archiving mailbox. However, the process is progressed by the NJRO Sponsor admin teams.

Requires NuTH Sponsor approval

Requires the CI (and NuTH PI cc’d) to be notified of the intention to archive the study at all locations. The CI should be given about 5 weeks to acknowledge.

Other Sponsor & requested by a NuTH team:

The requesting team register their request with the Research Archiving mailbox. The process is then progressed by the first requesting NuTH team who will cc approval, notification and acknowledgement correspondence with the Research Archiving mailbox.

Archive Destruction Approval Pack

The archiving destruction approval pack requires the following approvals, notifications and acknowledgements:

Requires other Sponsor approval. They should provide the retention period and date from when it should begin. Where Sponsor are not contactable (or no longer responsive) then request approval from the study’s CI. Where both the other Sponsor and CI (and NuTH PI cc’d) are not contactable (or no longer responsive) then request approval from NuTH’s NJRO Research Governance Team via the Research Archiving mailbox.

NuTH Sponsored & requested by a NuTH team:

Requires NuTH Sponsor approval

Requires the CI (and NuTH PI cc’d) to be notified of the intention to archive the study at all locations. The CI should be given about 5 weeks to acknowledge.

Requires NuTH Research Archivist notification and acknowledgement.

Notify NuTH’s Information Governance team (using the Record Destruction Form) of the NuTH teams intent to destroy the study archives. This must be repeated by each NuTH team intending to destroy their archives for the same study.

NuTH Sponsored & requested by a hosting location team:

The requesting team register their request with the Research Archiving mailbox. However, the process is progressed by the the NJRO Sponsor admin teams.

Requires NuTH Sponsor approval

Requires the CI (and NuTH PI cc’d) to be notified of the intention to archive the study at all locations. The CI should be given about 5 weeks to acknowledge.

Requires NuTH Research Archivist notification and acknowledgement.

Other Sponsor & requested by a NuTH team:

Register your request for an approval pack

Register your request via nuth.researcharchiving@nhs.net so that your request is coordinated. i.e. Your team may not be the the first to request an approval pack for this study and we need to prevent duplicating approval activities. If you are not the first requester then your request will be logged and you will be informed when the approval pack is complete.

Your request can be just a simple email with the minimum study details, or additionally attaching the optional checklist with a more robust list of study details and progress status.

Important Dates & Timescales

Retention Period: This is the length of time (in years) that the study will be archived for. This should have been defined in the study’s Protocol and defined in the your location agreement as what your location is contractually obligated to support. Please note that The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 will be introducing a standard 25 year retention of trial master files and medical records by 2026, but is not yet clear as to whether this will retrospectively impact on studies already archived.

Archive start date: The date from which the retention period will be begin. The archive start date should be defined by the Sponsor and be where the study is closed at all UK locations, not just your own. However, conflicting requirements, such as where your location are contractually obligated to archive for the retention period but you are unable to start archiving until all the other study locations have also closed. This could result in your site archiving for longer than your location’s contractual obligations, and needs to address funding of the extended archiving period.

Flowcharts

NJRO-REG-T-052 – Flowchart – Transfer Study Documents to Other Sponsor

NJRO-REG-T-053 – Flowchart – Archive Destruction Approval – Other Sponsor

NJRO-REG-T-054 – Flowchart – Archiving Approval – Other Sponsor

NJRO-REG-T-055 – Flowchart – Archive Destruction Approval – NuTH Sponsor

NJRO-REG-T-056 – Flowchart – Archive Destruction – NuTH Paper

NJRO-REG-T-060 – Flowchart – Transfer Extended Archive to Other Sponsor

NJRO-REG-T-062 – Flowchart – Archiving Approval – NuTH Sponsored

Forms & Checklists

NJRO-GEN-WI-006 – Sponsor Approval for Archiving & Destruction

NJRO-REG-T-059 – Checklist for NuTH Sponsored & NuTH Hosted Studies to be Archived or Destroyed

NuTH’s Information Governance Records Disposal Form