UNCLASSIFIED

Good afternoon Ms Quinn,
 
Thank you for your recent inquiry, seeking information relating to:

I am requesting the following information under the FOI:

1. What pre-prescribing medical risk assessment was applied to personnel
entering the trial? Where and when was this risk assessment carried out in
the protocol?

2. On how many occasions were personnel to be monitored for adverse drug
reactions during and after the trial?

3. How many adverse events were reported a) during the trial; b) after the
trial?

4. What was the specific nature of these adverse events, and the numbers
of personnel reporting in each category?

5. What recommendations / provisions were identified or instructed in the
ADHREC proposal relating to these trials for follow-up / treatment of
personnel suffering from adverse drug reactions?

As it currently stands your request is not considered valid as it poses
questions and requests information as opposed to seeking access to
documents.  Section 15(2)(b) of the FOI Act states: 

2)  The request must:

                     (a)  be in writing; and

                    (aa)  state that the request is an application for the
purposes of this Act; and

                     (b)  provide such information concerning the document
as is reasonably necessary to enable a responsible officer of the agency,
or the Minister, to identify it; and

                     (c)  give details of how notices under this Act may
be sent to the applicant (for example, by providing an electronic address
to which notices may be sent by electronic communication).

 
Notwithstanding, I sought advice from the Office of Joint Health, and they
suggested that you may like to make a direct request, outside of the FOI
Act, to them.  They can be contacted at: [1][email address]
 
Alternatively, should you wish to proceed with an FOI request, we suggest
you reframe your request to seek access to documents.
 
Kind regards
 
 
Theresa Stinson
Assistant Director - Media Case Management FOI
Ministerial and Executive Coordination & Communication Division
 
Building F065
Level 2-012
Gallipoli Barracks
ENOGGERA   QLD   4051
 
Ph: (07) 3332 6359
 
Alternative email: [2][email address]
 
Website:[3]http://www.defence.gov.au/foi/index.htm
Privacy Statement:[4]http://www.defence.gov.au/FOI/privacy.asp
 
FOI Act: [5]http://www.comlaw.gov.au/Details/C2015C0...
FOI Guidelines:
[6]http://www.oaic.gov.au/freedom-of-inform...
 

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