Protocol Title : A Randomised, open labelled study in anti ... - EME

Protocol Version 3 14/01/2013
This trial may be audited by the Sponsor, or the Competent Authority. Investigators are obliged to
cooperate in any inspection.
8.6 Serious Breaches in GCP or the Trial Protocol
All investigators participating in the trial will promptly notify the Chief Investigator or Sponsor of a
serious breach (as defined in Regulation 29A of the Medicines for Human Use (Clinical Trials)
Regulations 2004 [Statutory Instrument 2004/1031], as amended by Statutory Instrument
2006/1928) that they become aware of. The CI is then responsible for notifying the sponsor within
24 hours of becoming aware of a serious breach.
The Sponsor is responsible for notifying the licensing authority in writing of any serious breach of:
(a) The conditions and principles of GCP in connection with that trial; or
(b) The protocol relating to that trial, as amended from time to time in accordance with regulations
22 to 25, within 7 days of becoming aware of that breach.
A “serious breach” is a breach which is likely to effect to a significant degree:-
The safety or physical or mental integrity of the subjects of the trial; or the scientific value of the
trial.
Participating centres should contact the coordinating centre or CI for further information.
9 TRIAL COMMITTEES
9.1 Trial Management Group (TMG)
The Trial Management Group normally includes those individuals responsible for the day-to-day
management of the trial, such as the chief investigator, statistician, trial manager, research nurse,
data manager. The role of the group is to monitor all aspects of the conduct and progress of the
trial, ensure that the protocol is adhered To and take appropriate action to safeguard participants
and the quality of the trial itself. The TMG will meet monthly.
9.2 Trial Steering Committee (TSC)
The role of a Trial Steering Committee will be to provide overall supervision of the trial and ensure
that it is being conducted in accordance with the principles of GCP and the relevant regulations.
The Trial Steering Committee will be chaired by:
Decisions about continuation or termination of the trial or substantial amendments to the protocol
will be the responsibility of the Trial Steering Committee. The TSC will meet every 6 months and
may take the form of a teleconference or face-to-face meetings.
9.3 Data Monitoring and Ethics Committee (DMC)
The role of an Data Monitoring Committee will review the accruing trial data and assess whether
there are any safety issues that should be brought to participants’ attention or any reasons for the
trial not to continue. The Data Monitoring Committee is independent of both the investigators and
the funder/sponsor. It will meet 6 monthly which may take the form of a teleconference or face-toface
meetings. It will makes it recommendations to the Trial Steering Committee. The independent
chair is: Dr. M. H. Buch, Section of Musculoskeletal Diseases, Leeds Institute of Molecular
Medicine, University of Leeds, Leeds, UK
10 PUBLICATION POLICY
This is an investigator led trial; sponsored by the CI’s substantive employers, QMUL. The data
collected will not be used to license/ register any pharmaceuticals. Authorship of the final
manuscript(s), interim publications, or abstracts will be decided according to active participation in
the study design, trial management group and accrual of eligible patients. Contributing centres
Study: R4RA EudraCT: 2012-002535-28 36 / 34