Return To: Alex Hall, Research & Development, Quality & Clinical Audit,

Research & Development Committee Project ID Number: Chairman: Professor Kate Costeloe

Contact : Linda Stephenson Research & Development Manager To be completed by R&D Office Research and Development Office, Picton Suite, Homerton University Hospital NHS Trust Homerton Row London E9 6SR RESEARCH PROJECT REGISTRATION FORM

NOTES FOR COMPLETION OF THIS FORM 1. Please complete all sections 2. Please print clearly or type 3. Registration of your project is a mandatory requirement of the Culyer exercise 4. Your project will be included in the Trust’s National Research Register (NRR) submission unless you notify us otherwise 5. Failure to register projects with the NRR may directly influence the Trust’s R&D Levy income

1. PROJECT TITLE

2. MULTICENTRE / LOCAL RESEARCH ETHICS COMMITTEE APPROVAL Please quote the reference number given by MREC reference number: LREC reference number: the committee & supply a photocopy of the approval letter (if available) in addition to the application form

3. START AND END DATES Project start date: Project end date:

4. DETAILS OF LEAD INVESTIGATOR Title: Address:

Surname:

First name: Telephone number: e-mail address

Qualifications:

5. OTHER INVESTIGATORS Title: Initials: Surname: Appointment:

6. PRINCIPAL RESEARCH QUESTION (a brief outline of the main question to be addressed by the project)

Homerton R&D Registration Form August 2007 1 7. METHODOLOGY (Please give brief details of the design of your study eg randomised control trial, questionnaire based staff survey etc)

8 SAMPLE GROUP DESCRIPTION (e.g. 30 patients with diabetes + controls – please give details of how many patients are expected to be recruited from Homerton Hospital)

9 OUTCOME MEASURES (Endpoints or factors used to evaluate success of projects e.g. Quality of life; survival etc)

10 METHODOLOGY (please tick most appropriate) Re-analysis of original data Participant observations Cohort observation Case-note review Interviews Cross-sectional study Database analysis Questionnaire Epidemiology Laboratory Study Case control study Health services Research Randomised controlled trial Before-after trial Controlled trial without randomisation Other method please state

11 CONFIDENTIALITY (please indicate if the project should be treated as confidential - e.g. commercially contracted or with Intellectual Property issues) Yes  No  Note: if you feel there are intellectual property issues that may arise as a result of this project, please contact Bunia Gorelick.

12 MULTICENTRE RESEARCH (please indicate if the project is in collaboration with 5 or more other centres)

Yes No 

13 IS HOMERTON THE LEAD RESEARCH CENTRE?

Yes  No  If NO, please give name of Lead Research Centre for this study:

Please give details of any other organisations participating in this study

14 IS THIS PROJECT MULTIDISCIPLINARY? (i.e. involving at least 2 different groups of health professionals)

Yes  No 

Homerton R&D Registration Form August 2007 2 15 CAN THIS PROJECT BE DESCRIBED AS HAVING A PRIMARY CARE INTERFACE?

Yes  No  If ‘yes’, please specify with whom the project is in collaboration (please tick appropriately) General General Primary Community Dental Practice Care Group Trust Practice Other, please specify….

16 SPONSOR ORGANISATION (Please indicate if you wish Homerton Hospital to be the sponsor of the study or given details of who the sponsor is)

I am requesting that Homerton Hospital NHS Trust to act as sole sponsor Yes  No  for this project The following organisation is sponsoring this study:

Name of Sponsor

Status NHS or HPSS care organisation  Academic  Pharmaceutical Industry Medical Device Industry  Other 

Address

Declaration by the Sponsor’s Representative that they have agreed to sponsor the study and accept the duties of the sponsor as set out in NHS Research Governance Framework for Health and Social Care.

Signature Print Name

Post Organisation

Date (dd/mm/yyyy)

17 ACADEMIC QUALIFICATION (Is this to be submitted in part / fulfilment of an academic qualification?)

If Yes please give details Yes  No  Title of qualification Academic Institution Submission Deadline

18 FUNDING ARRANGEMENTS (Please list any awards made in respect of this project including a value for In Kind support (e.g. free drugs, equipment etc. You may enter more than one award if necessary. If an award is pending or at the application stage, please indicate in the Funding Organisation's Reference column) Name of Funding Organisation Funding Grant Duration Total Funding Organisation's administration (£) (e.g. MRC, British Heart Foundation, EC, NHS reference Executive, Industry, Internal University Funds) (Trust or named University, e.g. QMW)

Homerton R&D Registration Form August 2007 3 19 PROJECT COSTS (Although it is sometimes difficult to predict project costs (due to uncertainty over patient recruitment etc), it is vital that the Homerton has the opportunity to cost the NHS resource implications of all projects at the time of registration. Failure to do so puts the Homerton's NHS R&D Levy funding, which supports Trust R&D, at risk). Name of speciality from which patients will be drawn No. of extra bed days required per patient No. of extra day case attendances per patient No. of Homerton patients annually No. of extra outpatient visits per patient No. of Homerton patients in total No. of extra outreach visits per patient Does the project involve the use of Additional theatre time per patient (minutes) medications? Are additional If yes, please give details and costs equipment/prostheses/ consumables required?

Directorate Authorisation Clinical Director / General Manager Signature I confirm that the prospective research study detailed above is known to the clinical director and / or the General Manager of the directorate that is hosting the Signature research. I am happy for this study to be carried out in our directorate. Print Name

Position

Contact Number

Date (dd/mm/yyyy)

Lead Investigator Declaration Lead Investigator Signature I enclose the completed form, a copy of the project protocol, ethics submission details and data protection form Signature

Print Name

Position

Contact Number

Date (dd/mm/yyyy)

Return to: Linda Stephenson, Research & Development Manager, Research and Development Office, Picton Suite, Homerton University Hospital NHS Trust, Homerton Row, London, E9 6SR

Tel 020 8510 5134 Email [email protected]

Homerton R&D Registration Form August 2007 4