4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Duke Clinical Research Institute (DCRI) |
|
| Documented adherence to GCP guideline | Yes | Compliance with the US Code of Federal Regulations Title 21 parts 50 and 56, Title 45 part 46;, Food and Drug Administration guidances, including ICH E6; the US National Institutes of Health policies and the policies and requirements of Duke University Medical School Institutional Review Board which has oversight over all of DCRI’s human subject research. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Compliance with the US Best Pharmaceuticals for Children Act, applicable US Code of Federal Regulations and guidances, and the US National Institutes of Health policies |
| Documented adherence to ethical considerations | Yes | All studies must undergo independent ethics review and approval |
| Availability of Standard Operating Procedures (SOP) | DCRI's SOPs are only available on an as requested basis. A table of contents to our SOPs is provided as an attachment | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | DCRI can and does monitor most of its studies itself, including its pediatric studies, through our clinical operations group (currently approximately 175 staff members). However, for studies within the federally funded PTN, we share monitoring responsibilities with the Best Pharmaceuticals for Children’s Act Data Coordinating Center (BPCA-DCC). For each PTN study an agreement delineating the specific DCRI and the BPCA-DCC responsibilities is made. Further, for DCRI’s multi-national studies we employ local contract research organizations to conduct onsite monitoring in other countries, with DCRI overseeing their activities |
| Capacity to monitor performance of collaborating centres | Yes | |
| Quality control and quality assurance, raceability and data safety | Yes | Each functional group within DCRI has a set of SOPs governing their operations. There are 16 functional groups within DCRI including Clinical Data Management, Clinical Events Classification, Quality Assurance and Regulatory Compliance and Regulatory Services. We do not publish our SOPs but I have attached a table of contents of our SOPs. Individual SOPs are made available upon specific request to our QA group. |