Clinical Trial Agreement...Clinical Trial Agreement for Sponsored Clinical Trials Henry Yau BSc...
Transcript of Clinical Trial Agreement...Clinical Trial Agreement for Sponsored Clinical Trials Henry Yau BSc...
![Page 1: Clinical Trial Agreement...Clinical Trial Agreement for Sponsored Clinical Trials Henry Yau BSc (Biochemistry) MBA (Finance) Tel: +852 9097 0567 Email: yauhenry@hotmail.com 2012 HA](https://reader036.fdocuments.in/reader036/viewer/2022062606/5fdfd4125c29fd5dc23b3b39/html5/thumbnails/1.jpg)
Clinical Trial Agreement for Sponsored Clinical Trials
Henry Yau BSc (Biochemistry) MBA (Finance)
Tel: +852 9097 0567
Email: [email protected]
2012 HA Practical Workshop on Clinical Research Compliance
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Clinical Trial Agreement for Sponsored Clinical Trials
Highlights :
• Principles of clinical trial agreements
• Major contents in clinical trial agreements
• Management of clinical trial agreements
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Sponsor
Sponsored Clinical Trials as Contract Research
Principles of Clinical Trial Agreements
Study Site Hospital/Clinic
Investigator
Study Personnel
Publication Rights
Investigational Products
Funding
Study Data
Sponsored Trials
II
Contract Research
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Sponsor
Sponsored Clinical Trials as Contract Research
Principles of Clinical Trial Agreements
Terms and
conditions need
to be agreed
and documented
Study Site Hospital/Clinic
Investigator
Study Personnel
Publication Rights
Investigational Products
Funding
Study Data
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Sponsor
Sponsored Clinical Trials as Contract Research
Principles of Clinical Trial Agreements
Clinical
Trial
Agreement
(CTA)
Study Site Hospital/Clinic
Investigator
Study Personnel
Publication Rights
Investigational Products
Funding
Study Data
![Page 6: Clinical Trial Agreement...Clinical Trial Agreement for Sponsored Clinical Trials Henry Yau BSc (Biochemistry) MBA (Finance) Tel: +852 9097 0567 Email: yauhenry@hotmail.com 2012 HA](https://reader036.fdocuments.in/reader036/viewer/2022062606/5fdfd4125c29fd5dc23b3b39/html5/thumbnails/6.jpg)
Six Principles of Clinical Trial Agreements
Principles of Clinical Trial Agreements
• Indemnity
• Insurance
• Limitation of liability
Examples:
Risk exposure
of study site
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Six Principles of Clinical Trial Agreements
Principles of Clinical Trial Agreements
Examples:
• Timeline for trial
subject recruitment
• Time for case report
forms submission
• Frequency of
radiological imaging
Practicality of
operational
requirements
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Six Principles of Clinical Trial Agreements
Principles of Clinical Trial Agreements
Examples:
• Patients’ waiting time
for hospital services
• Deviation from routine
clinical operation
• Extra workload for
hospital staff
Influence on
normal healthcare
services
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Six Principles of Clinical Trial Agreements
Principles of Clinical Trial Agreements
Examples:
• Informed consent
• Coercive subject
recruitment
arrangement
• Reporting of safety
data to study site
Protection of
subjects’ rights, safety
and well-being
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Six Principles of Clinical Trial Agreements
Principles of Clinical Trial Agreements
Examples:
• Access to subjects’
medical records
• Long-term retention
of medical records
• Application to DOH
Consistency with
laws, regulations, GCP
& management policies
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Six Principles of Clinical Trial Agreements
Principles of Clinical Trial Agreements
Examples:
• Reimbursement for
hospital services
• Rights to use study
data for non-
commercial purpose
Protection of
study site’s interests
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Five Key Areas in a CTA
Major Contents in Clinical Trial Agreements
Study
Management
Study Site
Operations
Handling of
Study
Information
Liability
Management
Legal
Procedures
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Study
Management
Five Key Areas in a CTA
Major Contents in Clinical Trial Agreements
Study
Management
Study Site
Operations
Handling of
Study
Information
Liability
Management
Legal
Procedures
• Supply of investigational products and study materials
• Safety reporting
• Appointment of contract research organization (CRO), if applicable
• Monitoring, auditing and inspection
• Financial arrangements
Study Site
Operations
Handling of
Study
Information
Liability
Management
Legal
Procedures
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Study Site
Operations
Study
Management
Study
Management
Five Key Areas in a CTA
Major Contents in Clinical Trial Agreements
Study Site
Operations
Handling of
Study
Information
Liability
Management
Legal
Procedures
• Recruitment of human subjects
• Informed consent procedures
• Completion and verification of case report forms
• Archiving of study records
Handling of
Study
Information
Liability
Management
Legal
Procedures
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Handling of
Study
Information
Study Site
Operations
Study Site
Operations
Study
Management
Study
Management
Five Key Areas in a CTA
Major Contents in Clinical Trial Agreements
Handling of
Study
Information
Liability
Management
Legal
Procedures
• Ownership of study data and intellectual property rights
• Confidentiality of study information
• Registration of study with public clinical trial registries
• Publication of results
Liability
Management
Legal
Procedures
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Liability
Management
Handling of
Study
Information
Handling of
Study
Information
Study Site
Operations
Study Site
Operations
Study
Management
Study
Management
Five Key Areas in a CTA
Major Contents in Clinical Trial Agreements
Liability
Management
Legal
Procedures
• Indemnity
• Insurance
• Limitation of liability
Legal
Procedures
![Page 17: Clinical Trial Agreement...Clinical Trial Agreement for Sponsored Clinical Trials Henry Yau BSc (Biochemistry) MBA (Finance) Tel: +852 9097 0567 Email: yauhenry@hotmail.com 2012 HA](https://reader036.fdocuments.in/reader036/viewer/2022062606/5fdfd4125c29fd5dc23b3b39/html5/thumbnails/17.jpg)
Legal
Procedures
Liability
Management
Liability
Management
Handling of
Study
Information
Handling of
Study
Information
Study Site
Operations
Study Site
Operations
Study
Management
Study
Management
Five Key Areas in a CTA
Major Contents in Clinical Trial Agreements
Legal
Procedures
• Amendment and assignment of agreement
• Termination of agreement / termination of study
• Disputes resolution
• Governing law
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Who has the responsibility to manage a CTA ?
Management of Clinical Trial Agreements
Lawyer Investigator
CTAs are legal documents
only lawyers can understand !
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Who has the responsibility to manage a CTA ?
Management of Clinical Trial Agreements
Lawyer Management
CTAs are signed by
the CCE / HCE / COS !
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Who has the responsibility to manage a CTA ?
Management of Clinical Trial Agreements
Investigator Management
Clinical trials are conducted
by investigators !
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• Legal languages
• Legal liabilities
• Operational contents
• Funding arrangement
• Publication rights
• Protection of
subjects’ interests
• Resources allocation
• Influence on hospital
services
• Protection of
hospital’s interests
Who has the responsibility to manage a CTA ?
Management of Clinical Trial Agreements
Lawyer Investigator Management
![Page 22: Clinical Trial Agreement...Clinical Trial Agreement for Sponsored Clinical Trials Henry Yau BSc (Biochemistry) MBA (Finance) Tel: +852 9097 0567 Email: yauhenry@hotmail.com 2012 HA](https://reader036.fdocuments.in/reader036/viewer/2022062606/5fdfd4125c29fd5dc23b3b39/html5/thumbnails/22.jpg)
Standardization of CTAs in HA
Management of Clinical Trial Agreements
HA
Standard CTA
Since
13 October, 2010
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HA Standard CTA Template
Management of Clinical Trial Agreements
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Management of Clinical Trial Agreements
Cover
Agreement Terms &
Conditions Schedules
Confirm
Terms &
Conditions
General
terms &
conditions
for
ALL
STUDIES
Specify
information
for
INDIVIDUAL
STUDIES
HA Standard CTA Template
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Management of Clinical Trial Agreements
Cover
Agreement
Confirm
Terms &
Conditions
HA Standard CTA Template
Negotiate with each sponsor
Signing of the
Cover Agreement by HA
constitutes a Master CTA
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Management of Clinical Trial Agreements
HA Standard CTA Template
Completing the Schedules
For each clinical study
Signing of the Schedules
constitutes a CTA
Referring to the Master CTA
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Schedules for Individual Studies
Management of Clinical Trial Agreements
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Management of Clinical Trial Agreements
Schedules for Individual Studies
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Management of Clinical Trial Agreements
Schedules for Individual Studies
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Clinical Trial Agreement for Sponsored Clinical Trials
Highlights :
• Study sites need to consider 6 principles in CTA
development
• Each CTA includes 5 key content areas
• CTA management is the joint responsibility of
investigators, lawyers and hospital management
• When starting to plan for a sponsored study, check if
a Master CTA with the sponsor is available.