Useful websites / links for Trust-sponsored IMP clinical trials

www.hull.ac.uk/consortium - (click on site index - site map) for GCP forms and SOPs on-line.

http://www.gcptraining.org.uk/ – for GCP training on-line organized by Infonetica.

www.medicines.org.uk – for Summary of Product Characteristics or product information leaflet.

http://www.consort-statement.org - for a checklist to help with reporting randomised controlled trials.

EUDRACT – to get a Eudract number.
https://eudract.emea.europa.eu/

IRAS
https://www.myresearchproject.org.uk/
IRAS IT helpdesk 0207 0992015

MHRA (Competent Authority)

Email protocol to clintrial helpline for a decision on whether the study involves an IMP (put Scope-Protocol Review in subject).

Clinical Trial Helpline: clintrialhelpline@mhra.gsi.gov.uk

MHRA - Clinical Trials
10-2 Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ

Tel 020 7084 2000 (weekdays 9am - 5pm)
020 7210 3000 (other times)
Fax 020 7084 2353

Ethics Committee

For local advice:

Louise Hunn

EC Coordinator

louise.hunn@humber.nhs.uk Tel: 389246

Hull & East Riding LREC (North Bank)

Humber Mental Health Teaching NHS Trust HQ, Willerby Hill Business Park, Willerby HULL HU10 6ED

Dr D Horton - Chairman

Trust R & D department

Dr Ian Holland (R & D Director)
James Illingworth (R & D manager)
Sally Johns, Samantha Russell & Carol Hirons (Research Facilitators)
Mike Murrey (Data Processing Officer)
Jane Pacynko (Clinical Trials Monitor).
All are available on the HEYHT email system. Tel 461883 Fax 461886

R & D Office 6, 2nd floor, Daisy Building, Castle Hill Hospital, Castle Rd, Cottingham, East Yorks HU16 5JQ

Notification of substantial amendment * send to MHRA and REC and R &D must be sent a copy.
https://eudract.emea.europa.eu/docs/forms/Substantial_Amendments.doc .
An annual progress report needs to be sent to the EC who approved your study. This is due each year from when the approval was granted. The Trust must be sent a copy.
To download, go to Google –> NRES home page –> applicants –> after ethical review -> progress reports –> submission of progress reports –> clinical trials of IMPs. or use link: http://www.nres.npsa.nhs.uk/applicants/after-ethical-review/progress-reports/
An annual safety report * needs to be sent to the MHRA, main REC and Trust each year from when the CTA was granted for the duration of the study. An ASR form is available from from the R & D intranet site (GCP documents) or www.hull.ac.uk/consortium (NHS R & D consortium/ Site Index/ Site Map/ GCP forms). The copy of the ASR to the REC must be sent with the safety covering form available at: http://www.nres.npsa.nhs.uk/applications/after-ethical-review/safetyreports/safety-reports-for-ctimps/#safetyCTIMPsSubmission%20.
Notification of the end of trial * to the MHRA, REC and Trust must be given within 90 days of completing the trial or within 15 days if the trial ended prematurely. Use form below:
https://eudract.emea.europa.eu/docs/forms/Declaration_Of_The_End_Of_Trial.doc

* For the MHRA, forms should be sent as a PDF documents on disk to: Information Processing Unit, Area 6, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.