2. Clarifications
Funds
Grant Funded
Project
Clinical Study
Activity that delivers
Grant Funded
Grant Funded
Grant Funded
Project
Grant Funded
Project
Project
Project
Many to one
One to many
Many
Clinical Study
Clinical Study
Clinical Study
Clinical Study
Clinical Study
Clinical Study
3. Clinical Trial vs. Clinical Study
• Trial:
–
–
–
–
Surgery
Investigatory Drugs
Radiotherapy
Investigatory Medical
Devices
– MHRA Inspect-able
studies
– “High Risk”
• Study:
– Tissue/biological
sample/data collection
– Questionnaires
– Qualitative
– Physiological
measurements
– Medium-Low risk?
– Consider:
• Pregnant Women
• < 5 Years of Age
4. Actual Difference
• In legislation only?
• Additional bureaucracy?
• All should be conducted to high standard.
– Safeguard the science, patients and data.
– Institutional/Personal Reputation.
– Best practice: Good Clinical Practice (GCP).
• Requirement of Funding Bodies.
5. •
Pre-award
•
•
Discussions
NHS
R&D(s)
?
IRAS forms +
Associated documents
Sponsor Letter
Insurance Documents
NHS
Ethics
•REC Form
•
?
NHS
NHS
R&D
NHS
•SSI
R&D
R&D(s) Form
•R&D
•SSI
Sponsorship
•Pink form
Insurance
•Insurance
Questionnaire
•SSI(s)
•R&D Form
•One R&D Form
Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
•
?
Clinical
Trial
Unit
IRAS System
Post Award (3 Months)
–
–
–
–
Sponsor
+
Insurance
NHS
Ethics
NHS
R&D(s)
Sponsor
NHS
Ethics
NHS
R&D(s)
Sponsor
Close
– Close of study report
6. •
Pre-award
•
•
Discussions
NHS
R&D(s)
?
IRAS forms +
Associated documents
Sponsor Letter
Insurance Documents
NHS
Ethics
•REC Form
•
?
NHS
NHS
R&D
NHS
•SSI
R&D
R&D(s) Form
•R&D
•SSI
Sponsorship
•Pink form
Insurance
•Insurance
Questionnaire
•SSI(s)
•R&D Form
•One R&D Form
Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
•
?
Clinical
Trial
Unit
IRAS System
Post Award (3 Months)
–
–
–
–
Sponsor
+
Insurance
NHS
Ethics
NHS
R&D(s)
Sponsor
NHS
Ethics
NHS
R&D(s)
Sponsor
Close
– Close of study report
8. Exceptions
Research Tissue
Bank
Sponsor
Laboratory study only involving samples
from an NHS REC approved Tissue Bank
Research
Database
Sponsor
Study only involving Data from an NHS
REC approved Data Bank
University REC
(UREC)
Sponsor
NHS
R&D(s)
UREC
Sponsor
Study involving healthy participants
without storing tissue for research
Study involving NHS Staff without storing
tissue for research
9. •
Pre-award
•
•
Discussions
NHS
R&D(s)
?
IRAS forms +
Associated documents
Sponsor Letter
Insurance Documents
NHS
Ethics
•REC Form
•
?
NHS
NHS
R&D
NHS
•SSI
R&D
R&D(s) Form
•R&D
•SSI
Sponsorship
•Pink form
Insurance
•Insurance
Questionnaire
•SSI(s)
•R&D Form
•One R&D Form
Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
•
Clinical
Trial
Unit
IRAS System
Post Award (3 Months)
–
–
–
–
Sponsor
+
Insurance
NHS
Ethics
NHS
R&D(s)
Sponsor
NHS
Ethics
NHS
R&D(s)
Sponsor
Close
– Close of study report
10. Favourable Ethical Opinion
• NHS Ethics Committee
– IRAS NHS REC form
NHS
Ethics
•REC Form
• National Guidance:
– http://www.nres.npsa.nhs.uk/
• University Ethics Committee
– http://www.rcs.bham.ac.uk/ethics/index.shtml
• For studies involving: Healthy volunteers, relatives of
patients only.
• Not suitable for participants involved by virtue of their
disease
11. R&D Management Approval
• Applications to each relevant NHS
organisation.
• Submit:
NHS
R&D(s)
•SSI(s)
•One R&D Form
– the study-wide R&D form generated from the
integrated dataset in IRAS;
– the Site-Specific Information (SSI) Form providing
specific information about the conduct of the
research at the research site;
– supporting documentation as specified in the R&D
submission checklist in IRAS.
12. Multicentre studies
• Projects involving more than one NHS Trust
• NHS R&D management approval co-ordinated by
Coordinated System for gaining NHS Permission (NIHR CSP).
• Generic review approval
– Conducted on behalf of all Trusts
• Local review approval
– Can the local health trust host the study?
• Submit all documents to CSP
NHS
NHS
R&D(s)
NHS
R&D(s)
•SSI(s)
R&D(s)
•SSI(s)
•One R&D Form
•SSI(s)
•One R&D Form
•One R&D Form
– CSP distributes to relevant NHS Health Trusts
• For more information.
– http://www.crncc.nihr.ac.uk/about_us/processes/csp
13. Free to start study?
• Final document to allow study start:
– Local NHS Management Approval Letter
– “Green Light Approval”
14. •
Pre-award
•
•
Discussions
NHS
R&D(s)
Sponsor
+
Insurance
•Costs (if
necessary)
IRAS System
Post Award (3 Months)
–
–
–
–
IRAS forms +
Associated documents
Sponsor Letter
Insurance Documents
NHS
Ethics
•REC Form
•
NHS
NHS
R&D
NHS
•SSI
R&D
R&D(s) Form
•R&D
•SSI
Sponsorship
•Pink form
Insurance
•Insurance
Questionnaire
•SSI(s)
•R&D Form
•One R&D Form
Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
•
Clinical
Trial
Unit
NHS
Ethics
NHS
R&D(s)
Sponsor
NHS
Ethics
NHS
R&D(s)
Sponsor
Close
– Close of study report
15. NHS Ethics / University Ethics
Study Amendments
• Substantial Amendments
– Changes that will affect:
• The safety of the subjects of the trial
• The scientific value of the trial
• The conduct or design of the trial
• Minor Amendments
• Examples of substantial and non-substantial amendments
can be found on NRES website.
• Forms are part of IRAS
• Amendments must be notified to
– The Sponsor for approval in principle
– The REC
– The NHS R&D providing NHS R&D Management Approval
16. Study Reporting
• Annual Study reports to be sent to:
– The Sponsor
– The REC
– NHS R&D providing NHS R&D Management
Approval
• And final report at the end of your study.
• Same document to all
– NRES website for form
• http://www.nres.npsa.nhs.uk/
17. GCP training
• Key members of the research team have GCP
training.
• Mandatory for Trials
• Strongly advised for Studies
– 1 day
– Updates required every 2 years.
• www.crncc.nihr.ac.uk/training
– Taster course – 9th of March
18. Study Clinics
• Worried about the complex bureaucracy?
• Need some guidance?
• Want a “health check” for your ongoing
studies?
• One on one clinics lead by Research
Governance Officer + Research Facilitator
• Friendly and supportive!
• Accelerate start-up
