5 Clinical trials
5.1
Where the Grant is made available for clinical trials, each of
the Grant Holder and the Host Institution must comply with the
Special Conditions.
5.2
The Host Institution shall, when carrying out clinical trials
funded by the Grant,
5.2.1
comply with all applicable laws and Department of Health (“DH”)
guidance relevant to the clinical trial including but not limited
to UK legislation implementing the EU Clinical Trials Directive
(2001/20/EC) and other relevant EU Directives, the Human Tissue Act
2004, the DH “Research Governance Framework for Health and Social
Care” and any other relevant statutory requirements and/or
government guidance in force from time to time;
5.2.2
conduct clinical trials in accordance with the terms of all
relevant regulatory permissions and approvals, which may include
but not be limited to Clinical Trial Authorisation from the
Medicines and Healthcare Products Regulatory Agency (MHRA), ethics
approval from National Research Ethics Service (NRES), the terms of
any National Health Service and Health and Social Care (HSC)
clinical trials agreement, the letter of no objection from the MHRA
for the investigation of a non CE marked medical device or a CE
marked device being used for the new purpose and the permission
given by or on behalf of any NHS site R&D management;
5.2.3
comply with Data Protection Act 1998 requirements and any
relevant clinical trials medical confidentiality principles as may
be in force from time to time;
5.2.4
adhere to the principles on the review of patient identifiable
information and materials in the Caldicott Committee Report on the
review of patient identifiable information;
5.2.5
not disclose and ensure that no third party discloses the
identity of participants to third parties;
5.2.6
(where it is intended that trial data is to be published)
register the clinical trial on the International Standard
Randomised Controlled Trials Number (ISRCTN) Register.