Clarifications
Grant Funded Project
Clinical Study
Funds
Activity that delivers
Grant Funded Project
Clinical StudyClinical Study
Clinical StudyOne to many Clinical Study
Grant Funded Project
Grant Funded Project
Grant Funded Project
Many to one Clinical StudyGrant Funded
ProjectGrant Funded
ProjectGrant Funded
Project
Many to ManyClinical Study
Clinical Study
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
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.
NHSR&D•SSI
•R&D Form
• Pre-award• Discussions
• Post Award (3 Months)– IRAS forms +
– Associated documents
– Sponsor Letter
– Insurance Documents
• Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
• Close– Close of study report
NHSEthics•REC Form
NHSR&D•SSI
•R&D Form
Sponsorship•Pink form
Insurance•Insurance
Questionnaire
NHSEthics
NHSR&D(s)
Sponsor
NHSEthics
NHSR&D(s)
Sponsor
IRAS System
Sponsor+
Insurance
NHSR&D(s)
•SSI(s)•One R&D Form
NHSR&D(s)
ClinicalTrial Unit?? ?
NHSR&D•SSI
•R&D Form
• Pre-award• Discussions
• Post Award (3 Months)– IRAS forms +
– Associated documents
– Sponsor Letter
– Insurance Documents
• Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
• Close– Close of study report
NHSEthics•REC Form
NHSR&D•SSI
•R&D Form
Sponsorship•Pink form
Insurance•Insurance
Questionnaire
NHSEthics
NHSR&D(s)
Sponsor
NHSEthics
NHSR&D(s)
Sponsor
IRAS System
Sponsor+
Insurance
NHSR&D(s)
•SSI(s)•One R&D Form
NHSR&D(s)
ClinicalTrial Unit?? ?
Exceptions
SponsorResearch Tissue
Bank
SponsorResearch Database
SponsorUniversity REC
(UREC)
Laboratory study only involving samples
from an NHS REC approved Tissue Bank
Study only involving Data from an NHS
REC approved Data Bank
Study involving healthy participants
without storing tissue for research
SponsorURECNHS
R&D(s)
Study involving NHS Staff without storing
tissue for research
NHSR&D•SSI
•R&D Form
• Pre-award• Discussions
• Post Award (3 Months)– IRAS forms +
– Associated documents
– Sponsor Letter
– Insurance Documents
• Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
• Close– Close of study report
NHSEthics•REC Form
NHSR&D•SSI
•R&D Form
Sponsorship•Pink form
Insurance•Insurance
Questionnaire
NHSEthics
NHSR&D(s)
Sponsor
NHSEthics
NHSR&D(s)
Sponsor
IRAS System
Sponsor+
Insurance
NHSR&D(s)
•SSI(s)•One R&D Form
NHSR&D(s)
ClinicalTrial Unit??
Favourable Ethical Opinion
• NHS Ethics Committee– IRAS NHS 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
NHSEthics•REC Form
R&D Management Approval
• Applications to each relevant NHS organisation.
• Submit:– 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.
NHSR&D(s)
•SSI(s)•One R&D Form
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– CSP distributes to relevant NHS Health Trusts
• For more information.– http://www.crncc.nihr.ac.uk/about_us/processes/csp
NHSR&D(s)
•SSI(s)•One R&D Form
NHSR&D(s)
•SSI(s)•One R&D Form
NHSR&D(s)
•SSI(s)•One R&D Form
Free to start study?
• Final document to allow study start:
– Local NHS Management Approval Letter
– “Green Light Approval”
NHSR&D•SSI
•R&D Form
• Pre-award• Discussions
• Post Award (3 Months)– IRAS forms +
– Associated documents
– Sponsor Letter
– Insurance Documents
• Initiation – After all Local NHS R&D management approvals
– Notification of amendments
– Yearly report
• Close– Close of study report
NHSEthics•REC Form
NHSR&D•SSI
•R&D Form
Sponsorship•Pink form
Insurance•Insurance
Questionnaire
NHSEthics
NHSR&D(s)
Sponsor
NHSEthics
NHSR&D(s)
Sponsor
IRAS System
Sponsor+
Insurance
NHSR&D(s)
•SSI(s)•One R&D Form
NHSR&D(s)•Costs (if
necessary)
ClinicalTrial Unit
NHS Ethics / University EthicsStudy 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
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/
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
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