Checklist 6: Evidence summary for scientific indications

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Checklist 6: Evidence summary for scientific indications
Table 6a: Reference list for indications
Indication
Scientific indication
number/s
Non-specific
(Yes)
Specific
(Yes)
Table 6b: Reference list for items of scientific evidence
In the table below enter the citation details for the items of evidence supporting the indication/s listed in table 6a
You may have more than one item of evidence for each indication. Number the items of evidence to correspond with the indication number (for example: for evidence linked
to indication 1, the evidence number should be listed as 1.1, 1.2, 1.3; for indication 2, the evidence should be numbered as 2.1, 2.2, 2.3 etc.)
Evidence
reference
number/s
Author
Source title
Such as title of pharmacopoeia or textbook
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 Fax: 02 6203 1605 Email: info@tga.gov.au www.tga.gov.au
Reference/Publication Evidence Guidelines
Publisher
Include page numbers and edition number
Year
Table 6c: Evidence summary for scientific indications
Use the table below to summarise your evidence and justify how it supports the scientific indication/s for your medicine.
The ‘Evidence reference number’ should correspond to the number used in table 6b for each item of evidence.
Ensure that the reason for inclusion of each item of evidence is clear.
If aspects of the evidence such as dosages, preparation types, indications or patient populations differ from those applicable to your medicine, provide your justification in the
‘Summary of findings’ column.
Evidence
Indication
Substance
reference
number/s
used
number/s
Plant/animal
part and
preparation
Dosage
Patient
population
Health
benefits
Summary of findings
Balance of evidence
Daily
dosage,
frequency
& method
Subject,
characteristics,
health condition,
ages, gender,
ethnicity
Use scientific
terminology
and/or quote
from source
Include enough information to demonstrate
relevance and study outcomes. Any
justifications from table 4d of Checklist 4
should be included here.
‘Primary supporting’,
‘Secondary supporting’
Checklist 6: Evidence summary for scientific indications (May 2014)
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