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Feedback Form: NSW Health Standard Operating Procedures including Tele-trial components

FEEDBACK FORM

The Office for Health and Medical Research (OHMR) have released a suite of NSW Health standard operating procedures (SOPs) with tele-trial component for use in NSW Public Health Organisations involving tele-trial sites. The SOPs were developed to assist sites to conduct trial activities in accordance with Good Clinical Practice (GCP) and any relevant local and national requirements.

These SOPs have been written at a high level so that they can be implemented across all NSW sites. It is recommended, therefore, that any local detail is added in the form of work instructions. 

The review period is 6 months. After that, the SOPs will be revised to take into account the feedback received and thereafter, will be reviewed periodically to ensure currency and completeness.
 
1. Contact Information *This question is required.
ALL USERS ARE ENCOURAGED TO PROVIDE FEEDBACK DURING THE 6 MONTH REVIEW PERIOD.
PLEASE PROVIDE FEEDBACK ON RELEVANT SOPS BELOW
2. TT SOP-QA-01 Clinical Trial Training Qualification
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
3. TT SOP-QA-02 Hosting an Audit or Regulatory Inspection
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Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
4. TT SOP-QA-03 Sub-Contracting External Vendors
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Section: Purpose
Section: Scope
Section: Applicable to
Section: Background
Section: Definitions and Acronyms
Section: Procedure
Section: References
Section: Associated documents
5. TT SOP-TC-01 Trial Feasibility & Start-Up
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
6. TT SOP-TC-02 Delegation of Duties by the Principle Investigator 
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
7. TT SOP-TC-03 Informed Consent
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Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
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8. TT SOP-TC-04 Managing and Reporting Safety Events
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
9. TT SOP-TC-05 Reporting Non-Compliance and Suspected Breaches of GCP or the Protocol
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
10. TT SOP-TC-06 Investigational Medicinal Product Management and Emergency Unblinding
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
11. TT SOP-TC-07 Source Data and Case Report Form Completion
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
12. TT SOP-TC-08 Handling and Transporting Biological Specimens
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
13. TT SOP-TC-09 Investigator Site File & Essential Documents 
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
14. TT SOP-TC-10 Close-Out at a Trial Site
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
15. TT SOP-TC-11 Clinical Trial Archiving
Feedback on each section
Space Cell Issue with current wordingMissing or incorrect itemsSuggested resolution
Section: Purpose
Section: Scope
Section: Applicable to
Section: Definitions
Section: Background
Section: Procedure
Section: References
Section: Associated documents
17. Does your organisation currently have its own site standard operating procedures (SOPs) that includes tele-trial components?
Did this suite of SOPs assist in identifying the gaps within your exisiting site SOPs?
Would your site use these suite of SOPs? 
ALL USERS ARE ENCOURAGED TO MAKE SUGGESTIONS FOR IMPROVEMENT AND SUGGESTIONS FOR ADDITIONAL SOPS DURING THE 6 MONTH REVIEW PERIOD. 
If you like to discuss how these SOPs can be further adapted to your local setting, please contact the clinicaltrialsNSW unit at the Office for Health and Medical Research via email: clinicaltrialsNSW@health.nsw.gov.au
 
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