Quality assurance program

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We have developed and implemented a Quality Assurance (QA) Program for trial units supported by and affiliated with the NSW Cancer Trials Network. This includes the development of generic standard operating procedures (SOPs) for implementation across units in NSW.

The Cancer Institute NSW Clinical Trial SOPs have been developed as a practical guide to Australian and NSW regulatory requirements. The contents of these SOPs do not require site specific amendment or customisation for implementation, and are designed as high level documents which will not conflict with any site specific procedures already in place.

A guidance document has also been developed to support the implementation of these SOPs. Currently eight (8) SOPs have been developed and are available for implementation. SOP attachments have been developed as example documents and are provided in an editable format.

Guidance Document

Cancer Institute NSW Clinical Trial SOPs - Guidance Document

Standard Operating procedures

GEN-01: Production, Review, Approval and Archiving of SOPs

SOP GEN-01

Attachments:

SOP Template

GEN-02: Training Record - Documentation, Maintenance and Archiving

SOP GEN-02

Attachments:

Example: Training File Index

Example: Curriculum Vitae Template

Example: Employee Training Record

Example: Training Attendance Record

GEN-03: Maintenance of Equipment

SOP GEN-03

Attachments:

Example: Equipment Service Log

Example: Equipment Calibration Log

Example: Temperature Log

GEN-04: Document Management

SOP GEN-04

Attachments:

Example: Investigator Site File Index (ISF Index)

Example: Site Visit Log

Example: Site Signature and Delegation Log

Example: Subject Screening log

Example: Subject Identification Register/Log

Example: Subject Enrolment Log

Example: Protocol Exemption Request Form

Example: Protocol Exemption Log

Example: Temperature Log

GEN-05: Handling of Investigational Product

SOP GEN-05

Attachments:

Example: IP Receipt Form

Example: IP Accountability Form - single subject

Example: IP Accountability Form - multiple subjects

Example: IP Return Form

GEN-06: Procedures for Submission of a Clinical Trial to a Human Research Ethics Committee (HREC)

SOP GEN-06

Attachments:

Example: Checklist for HREC submissions

Example: Serious Adverse Event Notification Form

Example: Safety Report Submissions

Example: Annual Report Form

INV-01: Development and Review of Protocols and Protocol Amendments

SOP INV-01

Attachments:

Example: Protocol Template

INV-02: Participant Information Sheet and Informed Consent Form (PIS/ICF) Development and Review

SOP INV-02

Attachments:

Example: Informed Consent Form Template

Example: Informed Consent Form Checklist

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