For Sites

These are site resources we've come across and like. We take no responsibility for their suitability to your site's particular requirements, but hope they're helpful. If you have resources that may be useful for other sites and wish to contribute to this collaboration, please forward to sites@beltas.com to review for inclusion. Contributions will be acknowledged, unless the original contributer requests to remain anonymous.

SOP's
Best Practice
Reviews & Audits

SOP's

SOPs for Clinical Trial Units – Cancer Institute (Australia)
www.cancerinstitute.org.au/cancer_inst/research/trials_sops.html

SOPs – Victorian Managed Insurance Authority (Australia)
Site SOPs, guidelines, agreements and other site resources www.vmia.vic.gov.au/display.asp?entityid=3023#M4 (13 SOPs)

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Best Practice

The Importance of Retention (Australia) PDF 42Kb
You’ve worked hard to get the patients so don’t lose them! (Checklist & Article)
This article was first published by the Association of Regulatory and Clinical Scientists (ARCS) (Carnevale, E. – The Importance of Retention, ARCS Newsletter, June 2006, No 113, pp 24-25)

Registered Clinical Trial Units (UK)
Membership, competencies and criteria for trial sites
www.ukcrc-ctu.org.uk/Pages/default.aspx

Clinical Trials Networks - Best Practices (US)
Best practice resources including suggested site SOP's
www.ctnbestpractices.org

PharmaSchool Ultimate GCP Challenges (UK)
ICH-GCP online quizzes to test your knowledge
www.pharmaxm.com/can01.asp

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Reviews & Audits

Society of Clinical Research Associates (US)
Journal articles including FDA Inspector Perspectives
www.socra.org/html/newslett.htm#SoCRA_SOURCE_Journal_Articles

Good Clinical Practice in FDA-Regulated Clinical Trials (US)
FDA information including their Bioresearch monitoring program
www.fda.gov/oc/gcp/default.htm (Enforcement, Warning Letters etc)

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