--- title: "Standard operating procedures (SOP)" canonical: "https://research.refined.site/space/Research/124125198/Standard%20operating%20procedures%20(SOP)" format: markdown --- ### Standard operating procedures (SOP) **Clinical trial routine monitoring visit **([download](https://research.refined.site/space/Research/124125198/Standard+operating+procedures+(SOP)?attachment=/download/attachments/124125198/clinical-trial-routine-monitoring-visit.pdf&type=application/pdf&filename=clinical-trial-routine-monitoring-visit.pdf) PDF) This SOP outlines the preparation for, conduct and follow-up of a clinical trial routine on-site monitoring visit for industry-sponsored clinical trials at Waitematā DHB and is based on ICH-GCP Guidelines**.** **Managing adverse events in clinical drug trials and device trials** ([download](https://research.refined.site/space/Research/124125198/Standard+operating+procedures+(SOP)?attachment=/download/attachments/124125198/managing-adverse-events-in-clinical-drug-trials.pdf&type=application/pdf&filename=managing-adverse-events-in-clinical-drug-trials.pdf) PDF) See also **Adverse event reporting template for source documents** ([download](https://research.refined.site/space/Research/124125198/Standard+operating+procedures+(SOP)?attachment=/download/attachments/124125198/adverse-event-reporting-template.pdf&type=application/pdf&filename=adverse-event-reporting-template.pdf) PDF) Sets out the procedure for reporting an adverse or serious adverse event. Adherence to the guidance included in this SOP and associated source document template for reporting in clinical record should ensure that the rights, safety and welfare of clinical trial participants are protected, and compliance with protocol and legislative requirement is met. **Orientation for Clinical Research Nurses (CRNs) and Research Coordinators (CRCs)**  - [download](https://research.refined.site/space/Research/124125198/Standard+operating+procedures+(SOP)?attachment=/download/attachments/124125198/CRN-orientation.pdf&type=application/pdf&filename=CRN-orientation.pdf) PDF Provides research nurses and research coordinators who are  new to research with a starting point to find locality information, and to  serve as an overview of what the role involves, being mindful that the scope of the roles varies depending on the type of research, and the environment/context it is conducted in.   ### Pharmacy specific SOPs **Initial notification for a Pharmacy study** (go to [download](https://clinicaldecisions.atlassian.net/wiki/spaces/Research/pages/124125198/Standard+operating+procedures+SOP#Files-for-download) area) **Quote Request for a Pharmacy study** (go to [download](https://clinicaldecisions.atlassian.net/wiki/spaces/Research/pages/124125198/Standard+operating+procedures+SOP#Files-for-download) area) ICH GCP states overall responsibility for investigational products at each trial site rests with the principal investigator. At Te Whatu Ora Waitematā the principal investigator delegates responsibility for the investigational product(s) accountability to the Inpatient Pharmacy.  **“Notification Only” Clinical Trial Medications **-  click [here ](http://staffnet/QualityDocs/Quality%20Documentation/S3%20Hospital%20Operations/Pharmacy/%5BP%5D%20Notification%20Only%20Clincal%20Trial%20Medications%20-%20Notification%20Approval%20and%20Audit%20Oct23.pdf)to read the document. However, in certain situations the Te Whatu Ora Waitematā employed Principal Investigator may seek an exemption from Waitematā Pharmacy Services to manage oral medication trial stock in an area other than the Waitematā Pharmacy Clinical Trials Service. ### Files for download > Macro (attachments) --- ###### Last reviewed November 2023 Author: Kathryn Tennant