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Standard Operating Procedures (SOPs) for Clinical Trial Units

A key goal of the NSW Cancer Plan 2007-2010 was the development and implementation of a Quality Assurance (QA) Program for trial units supported by and affiliated with the NSW Cancer Trials Network. The program included 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

SOPs

SOP: GEN-01 PDF document. Adobe Acrobat required. [PDF | 4.78 MB]
Production, Review, Approval and Archiving of SOPs

Attachments:
1. SOP Template PDF document. Adobe Acrobat required.

SOP: GEN-02 PDF document. Adobe Acrobat required. [PDF | 3.89 MB]
Training Record - Documentation, Maintenance and Archiving

Attachments:
1. Example: Training File Index PDF document. Adobe Acrobat required.
2. Example: Curriculum Vitae Template PDF document. Adobe Acrobat required.
3. Example: Employee Training Record PDF document. Adobe Acrobat required.
4. Example: Training Attendance Record PDF document. Adobe Acrobat required.

SOP: GEN-03 PDF document. Adobe Acrobat required. [PDF | 3.56 MB]
Maintenance of Equipment

Attachments:
1. Example: Equipment Service Log PDF document. Adobe Acrobat required.
2. Example: Equipment Calibration Log PDF document. Adobe Acrobat required.
3. Example: Temperature Log PDF document. Adobe Acrobat required.

SOP: GEN-04 PDF document. Adobe Acrobat required. [PDF | 7.97 MB]
Document Management

Attachments:
1. Example: Investigator Site File Index (ISF Index) PDF document. Adobe Acrobat required.
2. Example: Site Visit Log PDF document. Adobe Acrobat required.
3. Example: Site Signature and Delegation Log PDF document. Adobe Acrobat required.
4. Example: Subject Screening log PDF document. Adobe Acrobat required.
5. Example: Subject Identification Register/Log PDF document. Adobe Acrobat required.
6. Example: Subject Enrolment Log Microsoft Excel document. Microsoft Office Excel required.
7. Example: Protocol Exemption Request Form PDF document. Adobe Acrobat required.
8. Example: Protocol Exemption Log Microsoft Excel document. Microsoft Office Excel required.
9. Example: Temperature Log PDF document. Adobe Acrobat required.

SOP: GEN-05 PDF document. Adobe Acrobat required. [PDF | 5.26 MB]
Handling of Investigational Product
Attachments:
1. Example: IP Receipt Form PDF document. Adobe Acrobat required.
2. Example: IP Accountability Form – single subject PDF document. Adobe Acrobat required.
3. Example: IP Accountability Form – multiple subjects PDF document. Adobe Acrobat required.
4. Example: IP Return Form PDF document. Adobe Acrobat required.

SOP: GEN-06 PDF document. Adobe Acrobat required. [PDF | 7.69 MB]
Procedures for Submission of a Clinical Trial to a Human Research Ethics Committee (HREC)

Attachments:
1. Example: Checklist for HREC submissions PDF document. Adobe Acrobat required.
2. Example: Serious Adverse Event Notification Form PDF document. Adobe Acrobat required.
3. Example: Safety Report Submissions PDF document. Adobe Acrobat required.
4. Example: Annual Report Form PDF document. Adobe Acrobat required.

SOP: INV-01 PDF document. Adobe Acrobat required. [PDF | 5.31 MB]
Development and Review of Protocols and Protocol Amendments

Attachments:
1. Example: Protocol Template PDF document. Adobe Acrobat required.

SOP: INV-02 PDF document. Adobe Acrobat required. [PDF | 7.54 MB]
Participant Information Sheet and Informed Consent Form (PIS/ICF) Development and Review

Attachments:
1. Example: Informed Consent Form Template PDF document. Adobe Acrobat required.
2. Example: Informed Consent Form Checklist PDF document. Adobe Acrobat required.

 

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