Effective Management of Clinical Trial Agreements and Personal Data (Privacy) (Amendment) Ordinance
Dechert's Hong Kong office will host this seminar featuring two presentations, "Effective Management of Clinical Trial Agreements" by the Clinical Trials Centre of The University of Hong Kong, and "Personal Data (Privacy) (Amendment) Ordinance" by Dechert.
Effective Management of Clinical Trial Agreements
Negotiation and management of clinical trial agreements (CTAs) is generally deemed a major rate-determining step for initiation of industry-sponsored clinical trials, whether in Hong Kong or overseas. Sponsors may from time to time encounter common issues in negotiation and management of CTAs with study sites, such as:
- Indemnity
- Study site documents and medical records
- Financial disclosure and personal data disclosure by investigators and other study site personnel
- References to overseas laws/regulations, sponsor’s internal policies or non-publicly accessible requirements
- Anti-bribery requirements including the U.S. Foreign Corrupt Practices Act (FCPA)
- Fair market value (FMV)
- Payment terms
- Termination rights
- Contract amendment and assignment
- Involvement of contract research organizations (CROs)
The general considerations of study sites in Hong Kong on the above specific areas will be discussed. Practical strategies on expediting conclusion and signing of master CTAs/CTA templates and study-specific CTAs will also be introduced.
Personal Data (Privacy) (Amendment) Ordinance
- Overview and potential impacts of the Personal Data (Privacy) (Amendment) Ordinance to the pharma industry and medical institutions
- Scope of relevant personal data and transferability of same
- Compliance checklist for pharma companies and medical institutions
- Privacy and confidentiality in ethics of clinical trials
- Legal concerns for conducting clinical trials in Hong Kong
The presentation will also address the interplay between the Personal Data (Privacy) (Amendment) Ordinance with other existing confidentiality requirements (e.g. Code of Professional Conducts of Medical Council of Hong Kong, Patients’ Rights and Responsibilities of Hong Kong Medical Association) as well as the prospective patient-oriented electronic health record (eHR) sharing system to be implemented by the Food and Health Bureau.
