History:  
National Institution of Drug Clinical Trial (NIDCT) in Xiangya Hospital Central South University was certificated by the China Food and Drug Administration (CFDA) in November, 2007. The institution includes 20 clinical trial departments, which are Department of Cardiovascular Medicine, Infection, Gastroenterology, Respiratory Medicine, Hematology, Rheumatology, Nephrology, General Surgery, Otolaryngology, Burns, Anesthesia, Ophthalmology, Oncology, Cardiothoracic Surgery, Dermatology, Endocrinology, Orthopedics, Neurology of Traditional Chinese Medicine (TCM), Gastroenterology of TCM and Rheumatology and Immunology of TCM. The institution also includes the Office of Good Clinical Practice (OGCP), which is the focal point within Xiangya Hospital for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in phase I-IV human clinical trials.


Development:
Since the establishment of OGCP, more than 400 clinical projects (including projects of drugs, devices, medical kits, etc.) have been undertaken and more than 20 projects were conducted under its leadership. According to GCP guidance issued by CFDA, the office has enacted an efficient clinical trial management system and comprehensive sets of standard operating procedures (SOPs) to ensure data reliability and compliance to GCP guidelines during the entire clinical trial process. With support of OGCP, some clinical trial departments have conducted many projects as a leading center and enjoy a good reputation among domestic and international pharmaceutical companies. 


In 2012, the Phase I Clinical Trial Center affiliated to OGCP of Xiangya Hospital was reconstructed according to national standards. Now it is equipped with 36 hospital beds and 1 intensive care unit.  In the past 5 years, the center has completed more than 40 phase I clinical trials and published more than 60 academic papers. Today, the center enjoys a high academic status nationwide.


Staff Composition:
Currently, 1 director, 1 executive director, 1 associate director, 1 secretary, 1 document manager, 1 drug manager, 2 clinical trial researchers and 3 clinical trial quality controllers work in OGCP, among whom 4 have senior professional title, 2 intermediate, and 1 holds primary title.


Major responsibilities of OGCP:

- Management and supervision of entire clinical trial process, including clinical trial approval and post-approval documents auditing and filing.

- Management of hospital-wide SAE during clinical trials.

- Providing consultancy support and quality control of clinical trials.

- Management of drugs used in clinical trials.

- Coordinating and supporting clinical trial departments to edit and review SOPs of clinical trials. 

- Planning, conducting, and assessing GCP training.

- Providing advice for application and review of clinical trial qualification examination.

- Providing hospital-wide management of clinical trial staffing and medical equipment deployment.

- Serving as a liaison with ethics committees, finance departments, network departments and clinical trial departments. 

- Supervision and management of clinical trial funding.

- Facilitating on-site inspection from competent departments, documenting inspection observations in an inspection report and obtaining responses in a timely fashion, including follow up of corrective and preventative action.

- Design, execution, supervision and summarization of phase I clinical trial protocols.

- Undertaking other daily work assigned by NIDCT of Xiangya Hospital.

 

Contact Us:
Add: Pharmacy Building, Xiangya Hosptital, Central South University

         87 Xiangya Road, Changsha, Hunan, P.R. China. 410008
Tel: +86-731-84327458 / +86-731-84327918 
Fax: +86-731-84327458 / +86-731-84327918