Doncaster Clinical Research Rotherham, Doncaster and South Humber NHS Trust NHS Doncaster Doncaster and Bassetlaw Hospitals

Amendments

The Clinical Trials Regulations (2004) define a 'substantial amendment' as one that is likely to affect to a significant degree:

  • the safety or physical or mental integrity of the subjects of the trial
  • the scientific value of the trial
  • the conduct or management of the trial, or
  • the quality or safety of any investigational medicinal product used in the trial.


This definition also applies for substantial amendments to non-Clinical Trials of Investigational Medicinal Products.

All substantial amendments require prior approval from the Research Governance office, in advance of implementation at the Trust. Research Governance approval will only be issued upon receipt of the Research Ethics Committee and MHRA approval, as appropriate. Substantial amendments are reviewed in full consultation with any support departments affected by the content, at the time of receipt.

Applicants are encouraged to submit substantial amendments, either via the NIHR Co-ordinated System for gaining NHS Permission (CPS) or directly to the Research Governance office, at the same time as submission to the regulatory bodies, to allow a parallel review. Active approval of amendments will be given by the Research Governance team, in no more than 35 days after receipt of the required documentation, or within 10 days of receipt of the required regulatory approvals, whichever is later. 

Non-substantial amendments should be notified to the Research Governance office, so an acknowledgement letter can be issued to ensure completeness of records.

Please note the addition of a new site or appointment of a new local Principal Investigator unrelated to the Trust, does not require submission to the Research Governance office, unless for a study which is being sponsored by a member organisation of Doncaster Clinical Research.

Urgent Safety Amendments

In accordance with the Clinical Trials Regulations, the Chief Investigator, Principal Investigator or Study Sponsor may take appropriate urgent safety measures in order to protect the participants of a Clinical Trial of an Investigational Medicinal Product (CTIMP) against any immediate hazard to their health or safety, without prior approval from the regulatory bodies or Trust Research Governance Department.

Please refer to the standard-operating-procedures for further information.

 

Doncaster
Clinical Research

First Floor 'C' Block
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
South Yorkshire
DN2 5LT

Tel: 01302 644073

R&D Strategy for Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust 2013 - 2018

 

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