Share this

Start-Up

A joined up approach delivers efficiency in study set-up

NRS operates a coordinated, managed, proportionate and streamlined system to facilitate local R&D Permissions. A single point of contact will take you through the study-wide governance review, including negotiation of budget and contract.

The NRS permissions system is designed to remove duplication of effort and standardise approach across Scotland wherever possible:

  • Central submission – documents circulated to all participating sites
  • Single point of contact to assess study-wide governance
  • Single budget and contract template for all sites in Scotland
  • Study-level Co-ordinated Pharmacy Review and cost
  • NHS Permission letters issued

Managed via a central permissions team, our clocks work on a rate-limiting basis and start upon submission of a full document set and stop when an action lies with Sponsor.  This ensures that the completion of both study-wide and local reviews is actively driven, which translates into rapid overall start-up times.

Multi-centre research in the UK

Upon completion of the study-wide review, study documentation and the study-wide governance report is distributed to participating nations. The participating nation will accept the study-wide governance review and perform nation specific checks.

Defined systems are in place to ensure that studies led in Scotland proceed smoothly through other UK nation’s start-up processes. The table below outlines the key points and provides contact points:

Nation Key points Contact points

England:

HRA/NIHR

NIHR Costing template validation: HRA will work with the NIHR to ensure validation completed rapidly.

HRA Acknowledgement letter

NIHR:

supportmystudy@nihr.ac.uk

HRA :

hra.approval@nhs.net

Wales:

HSCRW

 

Research:

permissions@wales.nhs.uk

Northern Ireland   Sally Docherty

Studies led in other nations

Processes are in place to facilitate the transfer of study documentation to our team upon the completion of study-wide governance checks from all nations within the UK.  However, as our process includes negotiation of study budget and contract, we currently recommend a parallel submission is made to the Permissions Coordinating centre.

Key information

We can work as fast as you can

Full document to site permission 117 days.

Final regulatory document to permission 77 days.

The full document set to the first patient in sites that have recruited at the time of report 116 days.

Site permissions in Scotland – best practice

Scottish sites aspire to be the first open and ready to recruit wherever possible and will work closely with Sponsors to achieve this.

To help your team realise the full potential of the streamlined permission process, hints and tips on best practice have been provided:

Submit directly to NRS as early as possible

  • Although NRS works within the UK regulatory framework, there is no need to wait for acknowledgements or approvals from any other system ahead of submission
  • Please send your documents to the Permissions Coordinating Centre as early as possible.

Talk to NRS

  • At the start of the process, it is good to speak with the allocated reviewer which will allow any key questions to be raised and timelines to be agreed

Set target dates

  • such as SIV date at the start of the process and work to maintain these dates wherever possible

Maintain momentum of review and budget negotiations

  • Work to answer queries on the budget or other study documentation as quickly as possible, which will ensure that the reviewer can process your application quickly without the need to re-visit submissions if significant time has passed since the query was issued

Provide what is needed early

  • The document submission checklist can be found here <link>
  • Update with changes and send through Ethics and MHRA correspondence as they become available.