APPENDIX Macquarie University by alicejenny

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									                                                    APPENDIX C:
                                                  CLINICAL TRIALS

Appendix C must be completed and attached to any application where the research involves a clinical
trial. Applicants should refer to the relevant University Guidelines
http://www.research.mq.edu.au/for/researchers/how_to_obtain_ethics_approval/human_research
_ethics/policy#guidelines , the National Statement Chapter 3.3 and are advised to seek clarification
from the Human Research Ethics Committee or the Research Office if unsure how to answer any
question.

Please mark with an X the appropriate box or boxes – more than one may apply.

1.     Does this study involve testing any of the following?

(a) A drug                                                                               Yes     No

(b) A surgical procedure                                                                 Yes     No

(c) A therapeutic intervention or device,
    e.g. manipulation or cognitive behavioural therapy                                   Yes     No

(d) A preventative procedure or device                                                   Yes     No

(e) A diagnostic procedure or device                                                     Yes     No

If you answered ‘yes’ to any of the above, please provide further details below:




2.    If you checked ‘yes’ to Item 1 (a) above, please provide following information:

(a) Please provide details of the substances used/administered in this study including dosage.




(b) What are the inclusion/exclusion criteria and the screening processes used?




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(c) Please outline the risks to participants (these should be included in your information statement).




(d) Please indicate whether there are any special authorisations or licences required for the possession,
supply and use of these substances. Please provide copies of all relevant documentation.




(e) Indicate how you would ensure safe storage and disposal of substances.




3.     Does this study involve any of the following invasive procedures?

(a) Skin penetration other than for blood sampling                                         Yes       No

(b) Taking biopsy or other tissue samples                                                  Yes       No

(c) Penetration of body orifices other than ear or mouth                                   Yes       No

(d) Insertion of a device into a body orifice or cavity                                    Yes       No

If you answered ‘yes’ to any of the above, please provide further details below:




4.    Does this study simply involve the evaluation of clinical outcomes
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      for treatments which participants are already undertaking?                     Yes        No

If you answered ‘yes’, please provide further details below:




      Does this study only involve participants completing questionnaires?           Yes        No

If you answered ‘yes’, please provide further details below:




5.    Does participation in this study require participants to cease
      their existing treatment or medication?                                        Yes        No


NB: The University insurer will not normally indemnify trials which require the participant to cease or
alter their existing treatment. For further details, please contact The Tax and Insurance Manager, Ms
Maggie Feng Phone: 9850-1683. Email: maggie.feng@mq.edu.au

If you answered ‘yes’ to any of the above, please provide further details below:




6.    Will pregnant or breast-feeding women be accepted into
      this study as participants?                                                    Yes        No

If you answered ‘yes’, please provide further details below:




7.     Is there any possibility that participation in this study may
       damage, change or influence a participant’s DNA?                              Yes        No

If you answered ‘yes’, please provide further details below:




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8.     Has the protocol for this trial been submitted to an external body for
       review such as a grant giving body?                                                Yes        No

If you answered ‘yes’, please provide further details below:




9.     Are resources and funding adequate to obtain useful results                        Yes        No
       from the proposed research?

If you answered ‘no’, please provide an explanation below:




10.     Please list all personnel associated with this project in the box below:




       Please advise the Ethics Secretariat of any change to the trial personnel to ensure indemnity cover.

11.    In this study, is an investigator or assistant required to be a
       registered medical practitioner, or other registered, qualified,
       health service provider?

                                                                                          Yes        No


12. Is the research being conducted under one of the following:

      (a) The Clinical Trial Notification Scheme (CTN)?                                   Yes        No

      (b) The Clinical Trial Exemption Scheme (CTX)?                                      Yes        No

       If you answered ‘yes’, please provide the CTN or CTX registration number below:




      (c) Will the Clinical Trial be registered in a publically accessible register?      Yes        No

       If you answered ‘yes’, please provide the register location and number below:




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13. Is the research using only approved drug(s)/device(s) in
     accordance with Therapeutic Goods Administration
    Approved Product Information?
                                                                         Yes           No            N/A


       If you answered ‘no’, please provide an explanation for your response below:




NB: If any devices are being used as part of this clinical trial, even if the devices are not the focus of the
research, it is your responsibility to contact the Therapeutic Goods Administration (TGA) to ensure that
the devices you intend to use are listed on the TGA Register for the therapeutic use to which you intend to
put them.


14. Will this research be undertaken on behalf of (or at the request of) a                  Yes       No
     pharmaceutical company, other commercial entity or any other sponsor?

If you answered ‘yes’, will the sponsor provide support in money or in kind? Please provide details
below:




15. If you answered Yes to question 13, will that entity undertake                          Yes       No
    in writing to abide by either the ABPI Clinical Trial Compensation
    Guidelines or the Australasian Pharmaceutical manufacturers
    Association Guidelines for Injury Resulting from Participation in
    an Industry-Sponsored Trial?

If you answered ‘yes’, please provide details. If you answered No, please provide an explanation:




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16.    If you answered Yes to question 14, will that entity undertake in
       writing to indemnify the institution, the Institutional Ethics
       Committee(s) and the researchers?                                                 Yes        No

If you answered ‘yes’, please provide details and include a copy of the letter of indemnity with your
application. If you answered No, please provide an explanation:




17.    If you answered Yes to questions 13, 14 & 15, does the sponsor
       hold a current insurance policy to cover this project?                            Yes        No

If you answered ‘yes’, please provide a copy of the current insurance policy. If you answered No, please
provide details:




Checklist for Clinical Trials:

When submitting an application to undertake a clinical trial of a drug or device the following documents
(the original copies) must be provided:

(a) Trial protocol

(b) Statement from the trial sponsor indicating compliance with the ABPI or APMA clinical trial
compensation guidelines

(c) Statement from the trial sponsor indemnifying the relevant Area Health Service, Macquarie
University, the Institutional Ethics Committees and the investigators (as appropriate)

(d) Certificate of currency/sponsor’s insurance


When submitting an application to undertake a clinical trial of a drug or device under the CTN and CTX
schemes, the following documents (the original copies) must be provided:

(a) Section 4 of the CTX application or, for a CTN application, summary information, pharmaceutical
chemistry, toxicology and clinical experience, i.e.

Summary statement
Overseas status
Pharmaceutical data sheet
Clinical summary
Objections/comments by other Institutional Ethics Committee(s), the TGA/overseas regulatory bodies
Investigator’s brochure
References to support efficacy and safety of the proposed use
Investigator’s own summary of the risks and benefits of the trial
Therapeutic Goods Administration/Clinical Trial Notification Application Form

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