Background
The group identified a need for standard operating procedures (SOPs) at clinical sites participating in cancer clinical research around the country. We conducted a survey distributed to our groups' email list (results reported at COSA ASM 2004). The survey indicated that few clinical research sites based within hospitals have existing standard operating procedures; those that do have SOPs rarely have a comprehensive set and no strategy for ongoing review and update of them.
A lack of comprehensive and updated SOPs is a common finding in sponsor audits of investigative sites. However, the development of comprehensive and compliant research SOPs is beyond the resources of individual departments and institutions.
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. As follow-up, we are working to provide training and review of the implementation of the SOPs across sites that choose to purchase them.
Description
The SOPs that will be available to COSA members cover all aspects of establishing and conducting clinical research at an investigator site. 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.
While the SOPs are not applicable to coordinating centres of multicentre research studies, we would value the endorsement of the cancer clinical trials groups. We will provide a copy of the SOPs to the Executive of these groups to review, endorse and promote to their member institutions.
Cost
Investigator sites:
Purchase initial copy: $500 + 10% GST
Additional Departments: $125 + 10% GST
Postage and handling: $10
We recognise that funds for all sites and groups are limited. Implementing SOPs at a site is expected to provide significant gains in the quality implementation and maintenance of research projects at the site. It will also provide excellent resources to new staff and reduce the loss of corporate knowledge when staff leave the organisation (we know that the clinical research workforce is highly mobile). Further, the costs to an individual site in producing SOPs of this breadth and quality would run to many thousands of dollars and require a significant time commitment.
We believe this is the most time and cost efficient method of providing a valuable resource to individual sites. Any funds recouped through the sale of SOPs will be used to fund an ongoing review of the implementation and use of the SOPs.
Training
The critical nature of training individuals in implementation and use of the SOPs has prompted our group to explore possible funding avenues for national and state-based workshops. We will endeavour to provide a series of workshops on an ongoing basis for our members to meet this need.
Standard Operating Procedures order form (pdf, 198kb)