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Study Site Contract Management & Legal Affairs

Signing of a clinical trial agreement (CTA) is an essential step before initiation of any sponsored clinical study or collaborative investigator-initiated clinical study. Efficient CTA discussion and execution is commonly deemed a rate-determining step for study startup.

In HKU/QMH, CTAs and other contracts related to clinical studies are centrally managed by HKU-CTC. The single point of contact and professional contract specialists warrant easy and efficient discussion and management of contracts.

CTA templates for both industry-sponsored and investigator-initiated studies, which were developed and are updated from time to time in accordance with the latest international and local clinical study requirements, are available. Sponsors and collaborators are welcome to develop organization-specific CTA templates or to enter into master CTAs with HKU through HKU-CTC. Standard contract amendment/assignment forms are also available in case amendment or assignment of CTAs or other contracts are required during the course of any clinical study.

Over the years, more than 170 sponsors/collaborators around the world have already concluded CTA templates or master CTAs with HKU and enjoyed expedited CTA execution and quick startup of their clinical studies.

Highlights
Professional consultation on clinical study contract and legal affairs
Standard CTA templates or other contract templates for clinical studies
Development of organization-specific CTA templates or master CTAs
Standard contract amendment/assignment forms for easy contract amendment/assignment