by clicking the arrows at the side of the page, or by using the toolbar.
by clicking anywhere on the page.
by dragging the page around when zoomed in.
by clicking anywhere on the page when zoomed in.
web sites or send emails by clicking on hyperlinks.
Bio Technology : October 2009
34 Australasian BioTechnology Volume 19 • Number 3 • October 2009 AusBioFEATURE By James Cameron, McCullough Robertson Top 10 clinical trial mistakes How to avoid the legal pitfalls Contracts and documentation associated with preparing for and managing a clinical trial create a number of onerous legal obligations and rights between investigators, sites, sponsors, contract research organisations (CROs), ethics committees and the Therapeutic Goods Administration (TGA). Here are 10 common clinical trial mistakes you should avoid: Agreements not refective of GCP 1. responsibilities The 'Note for Guidance on Good Clinical Practice (CPMP/ ICH/135/95), annotated with TGA comments' (GCP Guide- line) and the National Statement 2007 (National Statement) set out the key responsibilities of each party involved in a clinical trial in Australia. Compliance with these documents is mandatory. Both the sponsor and principal investigator for a clinical trial certify that they will conduct the clinical trial in accordance with these documents when they notify under the CTN scheme. Mistake: Failure to ensure that the drafting of a clinical trial agreement is consistent with the GCP Guideline, the National Statement and other applicable guidelines. Non-compliant ICFs 2. Informed consent related issues are among the most commonly cited deficiencies in GCP compliance inspections of clinical trial investigators and sites. The GCP Guideline and National Statement set out requirements for the form and content of Informed Consent Forms (ICFs). Mistake: Failure to make sure an ICF is consistent with Investigator's Brochure; failure to address the requirements of the GCP Guideline and National Statement; inadequate explanation of compensation rights for injury and who is responsible for these costs. Failing to consider relevant regulatory 3. documentation Regulatory documents are frequently updated or super- seded, so it is important to ensure that references to those documents relate to the correct edition, even when using clinical trial agreements approved by Medicines Australia. Not all regulatory documents require mandatory compli- ance, so consideration should also be given to whether all terms of a particular code or guideline should apply to the particular clinical trial in question. Mistake: Failure to properly acknowledge regulatory documents. Intellectual property rights 4. Properly dealing with the nuances of intellectual property in a clinical trial is important, but often overlooked. While a site needs to ensure that the intellectual property it might contribute to the clinical trial is not transferred to the spon- sor, a sponsor may require a right to licence the intellectual