Health (Clinical Trials – Agreements)

 

• Drafting and negotiation of numerous types of clinical-trial agreements (CTAs) – also known as a clinical study agreement (CSA) – such as: academic Institution CTA (AICTA) (generally either a subcontract or a sub-award that allows the lead site to recruit one or more sub-sites where the clinical trial will be conducted); industry-sponsor CTA (ISCTA) (may be initiated by either a sponsor or investigator and is used when the drug or device to be studied has funding provided by the sponsor); investigator-initiated CTA (IICTA) (generally used when an investigator sponsor supplies both the device or drug to be studied and the funding necessary for the clinical trial; multi-party material transfer agreements (MTAs) governing the transfer of research materials and confidential information between the sponsor, the research entity and other entities during the clinical trial Phases); and, sponsored projects (SPs) (used when the funding is provided by some third-party not directly involved in the clinical trial itself).

 

• Developed country-specific and project-specific CSA and CTA templates, such as for: clinical research associates (CRAs); clinical trial specialists (CTS); global regulatory operations (GRO) liaison and sponsor; project leaders (PLs); and also drafted, negotiated and administered project-specific revisions, amendments and addenda, for all studies within various small-scale and large-scale projects.

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• Drafting and negotiation of multi-party material transfer agreements (MTAs), which govern the transfer of research materials and confidential information between the sponsor, the research entity and other entities during the various Phases of the clinical trial.

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• Drafting and negotiation of data usage agreements (DUAs), for the interaction and treatment of data among the parties involved in the clinical trial, which should be attached to and incorporated into the CTA by reference. 

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• Drafting and negotiation of Health Insurance Portability and Accountability Act (HIPAA)-compliant business associate agreements (BAAs), which govern the interaction and treatment of data among one or more entities directly involved in the clinical trial, and outside third-party entities not directly involved in the clinical trial, for cybersecurity subject matter experts (SMEs) retained by one or more entities directly involved in the clinical trial, to protect the privacy (through use of various encryption standards) and security (through the blockchain) of the clinical trial data itself as it passes through servers in many jurisdictions.

 

• At a minimum, CTA should specify certain critical terms and conditions, such as: amendment protocol; care requirements for injured subjects; confidentiality requirements (perhaps expressed through a separate non-disclosure agreement – NDA – to be attached to, and incorporated into, the CTA by reference as an exhibit); dispute resolution protocol (such as the approved entity to be engaged, the standards to be used); governing law for all disputes and litigation; indemnification conditions; insurance requirements (limits and types); ; representations (such as the important representation by the reasearch entity or CRO that neither it, nor any of its employees, agents or other persons involved by it in the clinical trial, is currently debarred, suspended or excluded under the Federal Food, Drug and Cosmetic Act – FDCA – as amended, or disqualified under the provisions of the Code of Federal Regulations (CFR) 21 CFR Section 312.70) and warranties; requirements for reimbursement and payment; responsibilities of the site administrator; responsibilities of the sponsor; responsibilities of the designated research organization; responsibilities within the trial environment during the different Phases; ; terms of collaboration, intellectual property – copyright, inventions, trademark, patent – ownership and usage; use of name (generally applicable if an academic institution is involved)and, venue and governing law for dispute resolution and litigation.

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    Last updated 210509_1403