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Bio Technology : October 2009
Volume 19 • Number 3 • October 2009 Australasian BioTechnology 35 AusBioFEATURE Failure to consider insurance 9. Most clinical trial agreements (including those published by Medicines Australia) require the sponsor to provide evidence of its clinical trial insurance. Mistake: Failure to go beyond merely checking that a policy is in place to consider such things as whether the policy is a dedicated clinical trial insurance policy and whether the policy is 'occurrence-based' or a 'claims made and notified' policy. Failure to properly inform TGA 10. The Therapeutic Goods Act 1989 and its regulations require the TGA to be informed and notified within set timeframes of a number of issues before, during and after a clinical trial. TGA replacements or updates can result in forms becoming out of date or redundant. The TGA will usually reject incor- rect forms and this can delay the progress of a clinical trial. Mistake: Failure to notify the TGA within timeframes; failure to check for and use up-to-date forms. Conclusion To help minimise the potentially significant risks of non-com- pliance, expert legal advice should be sought in respect of the legal issues associated with a clinical trial, including the review, drafting and negotiation of the key agreements and documents entered into between the parties. James Cameron can be contacted on (07) 3233 8819 or via email at firstname.lastname@example.org property for the commercialisation of its drug or medical device. The sponsor will also want to ensure that it owns all intellectual property arising from the clinical trial. Mistake: Failure to properly consider licensing and owner- ship of intellectual property rights; failure to consider intellectual property representation and warranties. Inappropriate or inadequate indemnifcation 5. The mandatory Medicines Australia standard form of indem- nity grants a site and the Human Research Ethics Commit- tee an indemnity in respect of loss or damage arising from claims made by or on behalf of subjects. However, it does not address loss or damage suffered as a result of such things as intellectual property infringement claims by third parties. Sites should consider indemnities that are com- plementary to those in the indemnity form to help address risks that fall outside the scope of the Medicines Australia indemnity forms. Mistake: Failure to consider the limited scope of mandatory indemnity forms. Protocol deviations and violations 6. Unfortunately, departures from protocols outside those permitted by the GCP Guideline often occur. These can range from protocol 'deviations' that are unlikely to put subjects at risk through to 'violations', which may place both subjects and the integrity of data at risk. Mistake: Failure to ensure a clinical trial agreement is drafted appropriately to provide rights and remedies for departures from the protocol. Failing to address and understand privacy law 7. Generally, privacy laws require that consent be obtained from each subject for each action in respect of his or her personal information. In particular, the privacy section of an ICF should include a number of elements to address privacy law, including which standards apply to the particular information and what personal information (including photographs) will be collected from each subject. Mistake: Failure to properly deal with privacy law in an ICF or during performance of the clinical trial. Inappropriate publication rights 8. As clinical research is often performed by institutions that rely on the promotion of research to secure funding, the publication clauses in a clinical trial agreement are often contentious and heavily negotiated. Mistake: Lack of certainty in a clinical trial agreement regarding what information is allowed to be published, triggers and timeframes for review by the sponsor, what right the sponsor has to amend, delete or remove informa- tion on review and acknowledgement of authorship.