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					                      GRTPNZ -- Schedule A -- Edition 1.1 -- Form 11.1




                       Application for
                 APPROVAL OF A CLINICAL TRIAL
          under Section 30 of the Medicines Act 1981

   A completed and signed copy of this form must accompany each application for
       approval of a clinical trial under Section 30 of the Medicines Act 1981.


PART A: ADMINISTRATIVE INFORMATION
NOTE: Part A must be completed for all applications for approval of a clinical trial under
Section 30 of the Medicines Act 1981.


Title of Trial:

Protocol Number:

Trial Phase:

Ethics Committee Approval:               Yes              No              Requested

If yes, name of Ethics Committee:

If yes, Ethics Committee Reference Number:




SECTION 1: APPLICANT DETAILS

1.1 Applicant
NOTE: The applicant is responsible for the trial in New Zealand, and must be in New
Zealand. (see Guideline on the Regulation of Therapeutic Products in New Zealand - Part 11,
Section 3.3).


Company:

      Name:

      Postal address:

Person signing this application:

      Name:

      Designation:
      Phone:

      Fax:

      Email:


1.2 Address for correspondence relating to this application
NOTE: Correspondence may be addressed to the applicant or to another person nominated
by the applicant.

             Correspondence to be addressed to the applicant
             Correspondence to be addressed to:
                   Name:

                   Designation:

                   Company:

                   Postal address:

                   Phone:

                   Fax:

                   Email:


SECTION 2: INVESTIGATIONAL PRODUCTS
NOTE: Complete this section for EACH active pharmaceutical or biological medicine being
used in the trial for which consent for distribution in New Zealand has not been granted. Enter
‘N/A’ beside any details that are not applicable to the product.



2.1 Product details
             Trade name (if any):

             Dose form:

             Active ingredient:

             Chemical name:

             Biological name:

             Non-proprietary name:

             Identifying code:

             Other descriptor:
      Does the product contain a substance listed in a schedule to the Misuse of
      Drugs Act 1975?
                 No

                 Yes

                   The dispensing schedule (showing that not more than one
                   month’s treatment will be supplied to trial participants at one
                   time) is set out in




2.2 Product labelling
      "Double-click here to add a sample label"


"Click here to add another investigational medicine"



SECTION 3: TRIAL PURPOSE AND DESIGN

3.1 Brief summary of the purpose, justification for, and
    significance of, the trial:



3.2 Eligibility for abbreviated approval process
NOTE: If the answer is yes to each of the questions below then the trial is eligible for the
abbreviated approval process. (see Guideline on the Regulation of Therapeutic Products in
New Zealand - Part 11, Section 3.6).

      Is the proposed trial a bioequivalence study utilising an investigational
      product that contains an active pharmaceutical ingredient included a
      medicine that is approved for distribution in New Zealand?
                 No
                 Yes
                    Is the route of administration for the investigational product the
                    same as that for the approved medicine?
                                                                   No
                                                                          Yes
                    Is the dosage for the investigational product within the
                    recommended dosage range for the approved medicine?
                                                                          No
                                                                          Yes
3.3 Trial design
     Basic design:

              Comparative               Non-Comparative                 Dose-ranging
              Mono-therapy              Add-on or combination therapy

     Comparative studies:

              Randomised                Non-randomised
              Single blinded            Double blinded                  Non-blinded
              Parallel group            Crossover

     Comparator:

              Active                    Placebo
              Other- give details


3.4 Trial participants
     Total number of participants:

     Proposed number of New Zealand participants:

     Study period for individual participants:

     Treatment period for individual participants:

     Age range in years:

     Sex:       Female           Male           Both




SECTION 4: INVESTIGATORS AND TRIAL SITES

4.1 Principal Investigator
NOTE: Attach CV and signed consent.


     Name:

     Address:

     Designation:

     Qualifications (include NZMC Registration No. where applicable):
4.2 Responsible Clinician
NOTE: Required if Principal Investigator is not registered with the New Zealand Medical
Council. Attach signed consent.


      Name:

      Address:

      Designation

      NZMC Registration No.


4.3 Number of trial sites
      Where will the trial be conducted?
                Individual site in New Zealand

                Multicentre – New Zealand only                Number of sites:

                Multicentre – International                   Number of NZ sites:

            Total number of sites:


4.4 New Zealand trial site details
NOTE: Complete for EACH trial site in New Zealand.


      Name and address of site:

      Lead investigator at site (Attach CV and signed consent):

            Name:

            Designation:


      Site certification status

                  Site certification not required because trial participants will not
                  receive treatment as residential patients at this site
                  New site certification is provided with this application
                  Site re-certification is provided with this application. This replaces
                  the certification lodged on         (date)
                  Certification lodged           (date) remains   current. Recertification
                  not required.
"Click here to add another trial site"
SECTION 5: FEES AND PAYMENTS
The fee for an application for approval of a clinical trial is $6,525 GST inclusive.
The fee for an additional trial using the same medicine, submitted at the same
time, is $3,263 GST inclusive.

The fee for an application for approval of a clinical trial under the abbreviated
approval process is $360 GST inclusive.

Payments are to be made on an invoice basis only - do not send
payment with the application.

Upon receipt of an application Medsafe will issue a tax invoice which will be sent
to the applicant with the acknowledgement letter. Payment will be requested
within 7 days and will be required to validate the application

Customer reference to be quoted on the invoice (if required):


ATTACHMENTS
The following documents are provided with this application:
Protocol
Investigator’s Brochure
GMP Certification for manufacturer(s) of investigational product(s)
GMP Certification for packer(s) of investigational product(s)
Sample labels for each investigational product
Curriculum Vitae for each lead investigator
Signed consent from each lead investigator
Other (please specify):




Signature of New Zealand applicant                     Date
PART B: TECHNICAL INFORMATION                                           ABOUT             THE
MEDICINE BEING INVESTIGATED

NOTE: This part must be completed for applications for approval of clinical trials using
pharmaceutical-type medicines. It is not required for trials using gene or other biotechnology
medicines.

Please answer the questions in the space provided on the form.
Where a column is provided on the right hand side of the form, indicate the location of the
relevant information by entering ‘PR’ for protocol or ‘IB’ for investigator’s brochure, followed by
the page number in the relevant document. If the information is not included in the protocol or
investigator’s brochure, please provide comment and indicate whether supplementary papers are
provided.

CHEMICAL AND PHARMACEUTICAL DATA

      Chemical structure

      Stereochemistry

      Physicochemical data (incl. solubility, pKa)

      Formulation of investigational product

      Stability

      Bioavailability

ANIMAL DATA

      Pharmacology

      Toxicology

HUMAN DATA

      Pharmacokinetics

      Pharmacodynamics

      Efficacy

      Side effects

      Interactions

CURRENT REGULATORY                     STATUS         OF     THE      MEDICINE         BEING
INVESTIGATED

      Has this medicine been approved for use in any other country?
                 No
                 Yes
                   Country:
                   Date of approval (if known):
"Click here to add another approval country"

      Has this medicine been authorised for study for human clinical use in any
      other country?
                 No
                 Yes
                   Country:
                   Date of authorisation:
                   Extent or conditions of authorisation:
"Click here to add another authorisation"

    Total number of individuals so far studied on the medicine:

    Maximum duration of treatment studied:

    Maximum dose studied:

MANUFACTURER AND PACKER OF INVESTIGATIONAL PRODUCT

      Name of manufacturer:
      Address of manufacturing site:
             Evidence of GMP compliance for manufacturer provided
      Name of packer (if different from manufacturer):             .
      Address of packing site:
            Evidence of GMP compliance for packer provided:



"Click here to add another investigational product"


PART C: THE PROPOSED TRIAL
NOTE: This part must be completed for applications for approval of clinical trials using
pharmaceutical-type medicines. It is not required for trials using gene or other biotechnology
medicines.
                                                                      ‘PR’ or ‘IB’
PURPOSE OF THE TRIAL
                                                                      and page
                                                                      no.
What area of deficient information is being addressed by this trial (i.e. what is
the purpose of the trial)?


Specific statement of hypotheses to be tested


Justification for and significance of study


TRIAL PARTICIPANTS

Are any of the trial participants non-patient (healthy) volunteers?
         No
         Yes

Are any of the trial participants patient volunteers?
         No
         Yes - Primary diagnosis:

Are contrast/control groups used?
         No
         Yes - Contrast and matching variables specified

RECRUITMENT AND SELECTION METHODS

     Inclusion criteria

     Exclusion criteria

     Criteria for exclusion during trial

     Handling of emergencies during trial

     What is the estimated time to recruit trial participants?

THE MEDICINE

     Indication(s) for which the medicine is to be studied

     Dosage schedule

     Route of administration
     Washout of existing medication

     Other medicines/treatments to be continued during trial

     Other medicines not permitted during trial

ASSESSMENTS AND WHEN MADE

     Assessment of trial efficacy

     Assessment of toxicity/side effects

     Assessment of compliance

     Trial termination, if trial is hazardous (or obviously
     successful)

     Other


DATA ANALYSIS

Has a biostatistician been consulted?
        Yes
                 (Name and affiliation)
        No       Who will analyse the data?:


     Justification for number of participants to be recruited

     How dropouts and discontinuations will be handled

     Summary table of phases, measures and measurement
     points
     (Optional, but desirable in any complex trial)

Is eventual publication of the results in a medical/scientific publication an
objective of this study?
                             Yes
                             No

Comments: (Optional)


PATIENT INFORMED CONSENT (For information only)

     How dropouts and discontinuations will be handled
       Consent form and procedure

       Patient information sheet

       Nomination of patient advocate

TRIAL PARTICIPANT INDEMNITY INSURANCE

       Statement on compensation of participants for any injury
       occurring due to the trial




For Office Use Only

                                        Application Fee       $___________.00

        Fee for _____additional trial(s) using the same       $___________.00
                                               medicine

                                        Invoice amount        $___________.00

Invoice number:                                       Date:

(End of Form 11.1)

				
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