Hospital Research and Development Agreements by cly19468

VIEWS: 5 PAGES: 1

Hospital Research and Development Agreements document sample

More Info
									 MSF1: CHECKLIST FOR RESEARCHERS FOR NEW PROTOCOL SUBMISSIONS

                          HUMAN RESEARCH ETHICS COMMITTEE
                               APPLICATION CHECKLIST
                                   Please forward with your submission to
                                    the Human Research Ethics Committee

  1      NEAF (1 original and 17 copies)     (completed and locked)
         Ensuring all relevant signatures from Department Directors have been obtained
         (https://www.ethicsform.org/au/SignIn.aspx)

  2      HREC - Application/Submission Form (1 original)

  3      Participant Information & Consent Forms (1 original + 17 copies) Version,date + page number
                    including revocation of consent
  4      For experimental drugs:        CTX/CTN Form
                                        Overseas Regulatory Status
                                        Investigator's Brochure (4 Copies)
                                        Indemnity Form (Draft)
                                        Contract / Agreements (Draft)
                                        Current Certificate of Insurance

  5      Radiation Safety Committee Approval, if applicable.

  6      Is this work towards a degree/diploma, etc?                                Yes / No
         If so, include Supervisor's name and position and Supervisor's written approval

         Questionnaires, diaries, advertisements, data collection forms, brochures
  7              and product information included.
  8      Submission documents are bundled , ready for distribution to HREC members
         Bundle = 1 Cover letter, 1 NEAF, 1 Protocol, 1 PICF, etc


         A copy of all submission documents has been kept by the PI for auditing and
  9
         monitoring purposes

 10      On site sponsor arranged.
         (enclose supporting letter signed by all relevant Heads of Department)

 11      A Site Specific Assessment Form - SSA (signed by all relevant Directors of Department/s)
         ( https://www.ethicsform.org/au/SignIn.aspx )
 12      Fully sponsored trials attract a Protocol Levy.
         Is this Trial a fully sponsored trial?                                     Yes / No

         If yes, has an Invoice Memo been raised?                         Yes / No
         (Invoice Request Memo to A Gavrillidis Director Research Development & Ethics, CHR)

Signed                                                                  Date




Version 2, 10 June 2010

								
To top