5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Duke Clinical Research Institute (DCRI) |
|
| Evidence of collaboration with regulatory authorities | Yes | DCRI currently holds many multi-million dollar grants or contracts with the National Institutes of Health and leads several networks (e.g., the Pediatric Trials Network, the Antibiotic Resistance Leadership Group, the Heart Failure Network, the Childhood Arthritis & Rheumatology Research Alliance , the National Patient-Centered Clinical Research Network, NIADA Clinical Trials Network) all of which have their own websites). In addition, when the study qualifies, we must submit investigational drug or device applications to the Food and Drug Administration (FDA) and work with them throughout the study to ensure evaluable results. All of our studies that meet the requirements for registration (and many that do not require registration but we register anyway) are registered on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/home). A quick keyword search on that site on August 14, 2015 found 2296 DCRI studies, 750 with the age group of birth–age 17, and 65 neonatal studies. Finally, all of our research activities are overseen by the Duke University School of Medicine Institutional Review Board. |
| Capacity to provide competent consultation to regulatory authorities | Yes | |
| Formal meetings for clinical trials | Yes | Varies per study, always start up, periodic thereafter (usually monthly) and as needed. Protocol team meetings occur bi-weekly on most studies and there are monthly site wide telecons for active studies |
| Training courses given over the last 2 years | Yes | Training is provided on every protocol at every site; once activated monthly site wide calls are conducted to address issues and lessons learned, which may lead to additional training sessions |
| Training courses received over the last 2 years | Yes | Internal team training provided periodically for new processes and procedures, monthly regulatory update sessions, and periodic EDC training. Institutional ethics, data privacy and security, informed consent and GCP training required annually or biannually per SOPs, frequency depending on functional group assignment. |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |