Standard Operating Procedures

Background

In 2004 the group identified a need for standard operating procedures (SOPs) at clinical sites participating in cancer clinical research around the country.

Those that do have SOPs rarely have a comprehensive set and no strategy for ongoing review and update of them. These are common findings in sponsor audits of investigative sites.

COSA purchased a set of Investigative Site SOPs from The Centre for Clinical Research Practice Inc in 2004 at a cost of USD$1500. Our group has tailored the SOPs to the Australian Regulatory Environment.

Their primary value is in providing structured information, compliant with ICH GCP and FDA Code of Federal Regulations, and many template forms and checklists to assist and guide research staff through the process.

Availability

The SOPs will be available to any Australian institutions involved in cancer clinical research, with at least one member of staff a member of COSA. These SOPs were purchased under a multi-user option licensing agreement, allowing installation of the electronic version on a network server.

Cost

Investigator sites:
                   Purchase initial copy:         $500 + 10% GST
                   Additional departments:     $125 + 10% GST
                   Postage and handling:        $10

Standard Operating Procedures order form (pdf, 198kb)