13. Forms

• MEDSAFE forms

https://www.medsafe.govt.nz/regulatory/forms.asp

• Clinical Trial Site Notification

https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Clinical%20Trial%20Site%20Notification%20Form.pdf

• Link to Online Application Form 

https://nz.ethicsform.org/

• Application to accompany a request for a Certificate of Pharmaceutical Product 

https://www.medsafe.govt.nz/downloads/CPPApplicationForm.doc

• Participant Information Sheet and Consent Form Template

https://ethics.health.govt.nz/assets/Uploads/HDEC/templates/participant-information-sheet-consent-form-template-sep20.doc

• Data Management Plan Template

https://ethics.health.govt.nz/assets/Uploads/HDEC/templates/data-only-management-template-oct2020.docx 

• Standard Indemnity And Compensation Agreement For Clinical Trials In New Zealand Public Health Organisations

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiQufrKpZb7AhVPALcAHX7vCK4QFnoECBoQAQ&url=https%3A%2F%2Fwww.adhb.health.nz%2Fassets%2FUploads%2FADHB-NZ-DHB-Standard-Indemnity-01Jul10-v2-0-incl-Guidance-Document2.doc&usg=AOvVaw3B-UPmMt3g5BnOxg4mTffH

• Standard Operating Procedures for Health and Disability Ethics Committees

standard-operating-procedures-for-hdecs-v3-0.docx (live.com)