GRTPNZ -- Schedule A -- Edition 1.0 -- 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
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
Non-blinded
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
not required.
(date) remains
"Click here to add another trial site"
current. Recertification
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
MEDICINE BEING INVESTIGATED
ABOUT
THE
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
INVESTIGATED
STATUS
OF
THE
MEDICINE
Has this medicine been approved for use in any other country?
BEING
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.
PURPOSE OF THE TRIAL
‘PR’ or ‘IB’
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
medicine
$___________.00
Invoice amount
$___________.00
Invoice number:
(End of Form 11.1)
Date: