CRN NT APPLICATION FOR SERVICE SUPPORT COSTS- FY 2015/16

Full research grant applications made POST01/10/2012

SECTION A: ELIGIBILITY

  1. Have you read the DoH guidance Annexe A of ‘Attributing the cost of health and social care Research & Development’?tinyurl.com/SC-vs-RC
N.B. Failure to read these guidelines and subsequently incorrectly attribute activities to Service Support Costs will delay the processing of your application. /
  1. Please confirm that the full Research Grant funding application was made on or after 1st October 2012?
N.B. Please use the alternative form on the Noclor website if the research grant was made BEFORE 01/10/2012. /
3. Has your study received R&D approval at sites for which you are applying for funding?
N.B. SSCS can be calculated in advance but are only released after R&D assurance. /
  1. Have you attached a current version of the protocol?
N.B. We cannot consider applications received without a current protocol. /
  1. Please verify that you have completed the form in as much detail and accuracy as possible and will email the form to
N.B. Inaccuracy and lack of clarity will delay the processing of your application. /

SECTION B: APPLICANT’S DETAILS (this will normally be the CI or local PI of the study)

6. Title, First NameSurname
7. Position
8. Email Address / Telephone/ Address
9. Host organisation
10. Who is the CI?
N.B. Please give full title, name and address of CI (if different from the applicant details).

SECTION C: STUDY DETAILS

11.NIHR Portfolio ID Number and CSP ID / NIHR Portfolio ID ______CSP ID ______
12. Study Title
13. Study Acronym
14. Lead Site details
15. Provide a lay summary of the study
(not more than 300 words)

SECTION D: GRANT DETAILS

16. Who is your Grant funder and what amount was awarded? / Name of Grant Funder / Funder an AMRC charity? / Date of award / Amount Awarded (inc period award covers)

SECTION E: PREVIOUS RECRUITMENT PERFORMANCE- Only answer if recruitment started in CRN NT before the start of this financial year.

17. What was the expected vs. actual recruitment level in the CRN NT (Clinical Research Network- North Thames) for previous years?
N.B. Please provide explanations where possible. / Financial Year / Expected Recruitment / Actual Recruitment

SECTION F: RECRUITMENT FIGURES AND TARGETS

18. Start and End Date of recruitment within CRN NT / Start Date:______End Date: ______
19. Recruitment Target Nationally(this FY)
20. Recruitment Target Nationally (for study duration)
21. Recruitment Target for CRN NT (this FY)
22. Recruitment Target for CRN NT (for study duration)
23. Approximately how many individuals will need to be invited in order to screen one individual?
24. Approximately how many individuals will need to be screened in order to recruit one individual?
25. Recruitment target per site?
26. How many eligible patients must a site have in order to achieve the recruitment target?
27. How many practices are you looking to recruit in the CRN NT area? / Name of CCG / Number of practices per CCG / Number of patientsto recruit per CCG

SECTION E: SERVICE SUPPORT COSTS- “a patient care activity that is primarily undertaken to facilitate research or is driven by the NHS duty of care to a patient e.g. to ensure fully informed consent or to ensure the safety of a patient participating in research

28. How will potentially eligible patients be identified and who will undertake this activity? / e.g. Database search by PM OR In consultation identification by GP
29. How will potentially eligible patients be screened and who will undertake this activity? / e.g. Baseline BP check for eligibility by Practice Nurse or Medical Record Review by GP
30. Who will be consenting participants and where will consent take place? / e.g. GP to consent patients at GP practice or Practice Nurse to consent patients at patients home.
31. List the step-by-step recruitment activities at each site that you believe are eligible for Service Support Costs (SSC)
N.B. SSC can be only be claimed for:
  • site initiations
  • identifying patients
  • screening patients
  • consenting patients
  • safety monitoring
/ Activity (e.g. database search, screening etc) / Staff / Time per event/ per patient / No. of events/ no. of patients / Total time per practice
e.g. Database search- identify eligible patients / Admin staff / 1 hour / 1 search / 1 hour
e.g. Venepuncture- 3 month calcium blood test (safety check) / Practice Nurse / 10 mins / 40 patients / 6.66 hours
32. Is room hire required for screening and consenting patients?
N.B. SSC may cover room hire for screening and consenting patients ONLY (i.e. no SSC to cover room hire to conduct research activity) /
If Yes, please state the total No. of hours of room hire for each site to screen and consent patients, this FY
Hours of room hire (this FY) : ______Over what duration______
e.g. 6 hours eg. 3 months

SECTION F: RESEARCH COSTS- “the costs of the R&D itself that ends when the research ends. They relate to activities that are being undertaken to answer the research questions.”

N.B. This information is required to ensure that the sites costs for involvement in your study are met (activities not accounted for by SSCs). Adequate remuneration for activities will encourage a higher uptake of your study by practices.

33. List all Research Costs that are paid to sites by your Research Grant. / Activity (e.g. database search, screening etc) / Staff / Time per event/ per patient / No. of events/ no. of patients / Total time per practice / Payment per practice
e.g. CRF Completion- 3 month Lifestyle CRF / Practice Nurse / 30 mins / 40 patients / 20 hours / £560
e.g. CRF Completion- 12 month medical record review / Practice Nurse / 15 mins / 35 patients / 8.75 hours / £245
e.g. SAE reporting / GP / 15 mins / 4 SAEs / 1 hour / £70
34. Is room hire required forresearch activities?
N.B.Baseline and follow-up measurements are research activities. /
If Yes, please state the total No. of hours of room hire for pure research activities, for this FY for each site.
Hours of room hire (this FY) : ______ Over what duration______
e.g. 6 hours eg. 3 months

SECTION G: INFRASTRUCTURE SUPPORT

35. What support do you require (e.g. a data manager)?
Inc. start/end dates and grade
36. What is the purpose of the support requested and what are the expected outcomes and benefits from this support?
37. Why was this support not provided or sought through the original research grant?

Please email the completed form along with a current protocol

CRN NT SSC Application- PRE 01.10.2012 Research Grant (v.2.1 S.FOROGHI)Page 1