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 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 GRTPNZ -- Schedule A -- Edition 1.0 -- Form 11.1

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. 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 $______.00 medicine

Invoice amount $______.00

Invoice number: Date:

(End of Form 11.1)