--- title: "Policies" canonical: "https://research.refined.site/space/Research/48333641/Policies" format: markdown --- ### Health New Zealand Information and Records Management policy The national Health NZ Information and Records Management policy is now available and can be viewed [here](http://staffnet/QualityDocs/Quality%20Documentation/O3%20Management/10%20Information%20Services/%5bP%5d%20Information%20and%20Records%20Management%20Policy%20Jul24.pdf). The Policy applies to all information and records created or received as part of Health NZ business. It outlines everyone’s responsibilities and accountabilities to access, create, maintain and lawfully dispose of information and records. This national policy replaces the previous district Corporate Information Management policy. For clinical record enquiries, please email [Vanessa McGill](mailto:vanessa.mcgill@waitematadhb.govt.nz) or call (021) 928320. For corporate records enquiries, please email [Rutravee Sitarachiyanon](mailto:Rutravee.Sitarachiyanon@waitematadhb.govt.nz) or call (021) 349845. ### [Interventional and observational research, audit and evaluation](http://staffnet/QualityDocs/Quality%20Documentation/O7%20Research/Policies%20&%20Standard%20Operating%20Procedures/[P]%20Research%20-%20Interventional%20-%20Observational%20-%20Audit%20Research%20and%20Evaluation%20Nov23.pdf) This policy outlines HNZ/TWO – Waitematā district’s locality responsibility, expectation and business processes to support, approve, conduct and monitor the conduct of research, clinical audit and related activity through to dissemination and translation of the outcomes from such activities. ### [Patient Information Management System (iPM) alerts for clinical trial participants](http://staffnet/QualityDocs/Quality%20Documentation/O7%20Research/Policies%20&%20Standard%20Operating%20Procedures/%5bP%5d%20iPM%20Alerts%20for%20Clinical%20Trial%20Participants%20Feb21.pdf) Consumers enrolled in research trials require close monitoring during their participation to assure consumer safety at all times. As part of the safety monitoring process a local alert is added to the Patient Information Management System (iPM) for all research participants at Te Whatu Ora - Waitematā. This alert displays information about the consumer’s participation in a research trial and gives details about the investigator and his/her contact details which serve to maintain patient safety and study protocol adherence. The Principal Investigator or the Clinical Research Nurse/Coordinator (via delegated authority) will complete this for each eligible research participant. ### [National medical warnings for clinical trial participants](http://staffnet/QualityDocs/Quality%20Documentation/O7%20Research/Policies%20&%20Standard%20Operating%20Procedures/%5bP%5d%20National%20Medical%20Warnings%20for%20Clinical%20Trial%20Participants%20May21.pdf) Additionally, an alert should be added to the National Medical Warning (NMW) system via the Patient Information Management System (iPM) for all clinical trial participants as per policy iPM alerts for Clinical Trial participants. ### [Obtaining informed consent for participation in research](http://staffnet/QualityDocs/Quality%20Documentation/O7%20Research/Policies%20&%20Standard%20Operating%20Procedures/[P]%20Informed%20Consent%20for%20Participation%20in%20Research%20Nov23.pdf) This policy applies to all HNZ/TWO - Waitematā staff and visiting researchers involved in the provision of information to, and obtaining the voluntary and informed consent of, potential participants in research, QI and related activity. The researcher is positioned at the centre of the informed consent process in terms of responsibility and accountability. Policy guide: [Informed consent for participation in research](https://clinicaldecisionsupport.atlassian.net/wiki/spaces/RESEARCH/pages/263815194/Informed+consent+for+participation+in+research)* restricted* ### [Privacy - third party request policy](http://staffnet/QualityDocs/Quality%20Documentation/O3%20Management/09%20Privacy/[P]%20Privacy%20-%203rd%20Party%20Requests%20Jun24.pdf) This document sets out the expected processes for dealing with 3rd party requests for personal or health information (i.e. requests made by an individual or organisation for personal or health information about someone other than himself or herself). ### “Notification Only” Clinical Trial Medications – Notification, Approval and Audit   This policy specifies 1. The criteria for when the Waitematā District Pharmacy Service (including both Inpatient and Outpatient Pharmacies) does not need to review the research protocol related to a clinical trial medication, whereby, there will be no requirement for pharmacy to order, receive, store, dispense, or dispose of medications. 2. The processes to be undertaken by the Principal Investigator/delegate (e.g. Clinical research nurse) when: a. Requesting approval for storing medication in an area other than the Waitematā Inpatient Pharmacy Clinical Trials Service b. Notifying the Pharmacy Service Manager of intent to undertake a “notification only”. --- ###### Last reviewed January 2025 Author: Kathryn Tennant