Trans-Tasman Radiation Oncology Group Inc

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					                                New Proposal Synopsis Form
                                 Guidelines for Completion

                                  CATEGORY “A” TRIALS


                           Please complete the attached form and return by
                                      Friday 17th August 2012




Schema:                                           Provide a schema including all treatment modalities, the
                                                  dose / schedule / route of all agents, and stratification /
                                                  registration / randomisation points.

Rationale / hypothesis:                           Briefly summarise the rationale for the proposed study,
                                                  providing references and data supporting it. State the
                                                  hypothesis or clinical question to be tested. The
                                                  experimental design must be appropriate to answer the
                                                  question asked.

Endpoints / Statistical considerations:           State the endpoints of interest and the level of activity of
                                                  interest.

Proposed sample size:                             The sample size should be planned to answer the
                                                  clinical question with sufficient statistical power.

Other Considerations:                             Has a Radiation Therapist and/or physicist been
                                                  consulted on trial design and QA issues?

                                                  Is there potential for a technical sub-study/question?

                                                  Have all relevant disciplines been consulted?




              Please return the completed report to: michelle.hall@trog.com.au

                        Michelle can be contacted on 02 4014 3911 for any enquiries.




TRANS TASMAN RADIATION ONCOLOGY GROUP LIMITED | ACN 132 672 292
New Trial Proposal Guidelines
Last updated September 2008                                                                        Page 1 of 1
                          New Trial Proposal Synopsis

                                                 ASM 2013
                                       CATEGORY “A” TRIALS


Please refer to the TROG Trial Development Resources when completing this form. Available to TROG members at:
http://www.trog.com.au/Portals/0/Resources/TROG%20Trial%20Development%20Resources_Sept08_FINAL.pdf

The TROG Scientific Committees “new proposal sub-committee” will review this proposal and will request clarification
and/or provide feedback as soon as possible.

Closed boxes are to be “checked” where applicable (place the curser on the check box, right click the mouse, select
properties, select checked, select OK).



   Submission details

   Date of submission:

   Full Trial Title:




   Trial acronym:



                                            II       III             Other, specify
   Phase:

   Name of Proponent:

   Institution:

   Phone:

   E-mail address:




   TRANS TASMAN RADIATION ONCOLOGY GROUP LIMITED | ACN 132 672 292
   New Trial Proposal - Category A Trials
   Version 3, FINAL_2011_09_23                                                                            -1-
Collaboration Details
Provide other group details:

         Collaborating Group (1)         Group Name:

                                         Contact person:




         Collaborating Group (2)         Group Name:

                                         Contact person:

                                       E-mail:
         Specify which group will be the lead group:

         NB: if the trial is predominantly asking a radiation
         therapy question, it is recommended that it be lead
         under the auspices of TROG.

Schema:




Rationale:




Hypothesis (es) to be tested:




Endpoints / Statistical Considerations:




Proposed Sample Size:




Proposed amount and source of funding (please attach a copy of any applications
submitted):




TRANS TASMAN RADIATION ONCOLOGY GROUP LIMITED | ACN 132 672 292
New Trial Proposal - Category A Trials
Version 3, FINAL_2011_09_23                                                   -2-
Other Considerations:

         RT and/or physicist Consultation     (if yes, give details)




         Technical Sub-study/Question         (if yes, give details)




         Have all relevant disciplines been
         consulted?                           (if yes, give details)




References:




TRANS TASMAN RADIATION ONCOLOGY GROUP LIMITED | ACN 132 672 292
New Trial Proposal - Category A Trials
Version 3, FINAL_2011_09_23                                            -3-

				
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