2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Duke Clinical Research Institute (DCRI) |
|
| Existence of an identified contact person for external enquiries | Yes | Dr Brian Smith is our primary contact for Enpr-EMA and has volunteered to be the initial contact point for all enquiries. Dr Smith may be reached at Brian.Smith@dm.duke.edu |
| Existence of an internal steering committee | Yes | An organizational chart of the composition of our federally funded Pediatric Trials Network is available on the PTN website (http://pediatrictrials.org/wp-ontent/uploads/2014/10/ptn_org_chart_05dec2014.jpg). Similar organizational structures exist for the other NIH funded networks listed in response to “Description of the Network” question, some of which are available on the public facing websites. The DCRI leadership team is found on the DCRI website at: https://www.dcri.org/directory. DCRI’s pediatrics group is overseen by its faculty directors, Dr. Li and Dr. Benjamin (see: https://www.dcri.org/our-research/pediatrics). In addition, all of our human subject research is overseen by the Duke University School of Medicine Institutional Review Board: http://irb.duhs.duke.edu/ |
| Existence of an external advisory steering committee directing the reporting party | Yes | The Pediatric Trials Network has an external data monitoring committee (the Best Pharmaceuticals for Children Act [“BPCA”] DMC, as shown on the PTN organization chart (http://pediatrictrials.org/wp-content/uploads/2014/10/ptn_org_chart_05dec2014.jpg). PTN leaders and collaborators are also listed on the website (http://pediatrictrials.org/background/ptn-leaders-and-collaborators). Otherwise, all DCRI studies which are federally funded will be overseen by the NIH project officer (grants) or the NIH contract technical representative (contracts) assigned by the particular funding institution. Investigational drug or device studies submitted to the Food and Drug Administration are overseen by the reviewers within the applicable division (e.g. cardiovascular, infectious diseases etc.). These are all assigned per internal agency or institute policy and there is no resource through which any particular funding or regulatory agency staff assignment is publically available |
| Existence of a website | Yes | The various research networks listed in description of Network above have their own websites, links provided. |
| Existence of newsletter | Yes | Most of the networks have newsletters, available on their websites. |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | The DCRI is an academic research organization which maintains internal databases of all of our studies from initial site feasibility through the study’s’ data lock and results analysis. Databases are created for the purposes of data collection of the specific trial. Depending on the type of study, the study databases will include pharmacokinetic, pharmacodynamic and pharmacogenetic data. |
| Provisions to ascertain data protection and data security | Yes | Because much of our work at DCRI is through government grants and contracts, DCRI maintains a Federal Information Security Management Act (FISMA) compliant zone for much of its data. We are also subject to the privacy and security requirements of the US Common Rule (45 CFR 46, Subpart A). As a covered entity healthcare provider, DCRI must also comply with the U.S. Health Insurance Portability and Accountability Act (HIPAA) privacy and security requirements (Public law 104-191). As a healthcare organization we are also accredited by the Joint Commission, an independent accrediting body that develops performance standards that address crucial elements of operation, such as patient care, quality assurance and consumer rights (see, http://www.jointcommission.org/). We are also governed by the accreditation standards of the Association for the Accreditation of Human Research Protection Programs, an independent accrediting body that works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research (see, http://www.aahrpp.org/). Finally, all of our research is reviewed by the Duke University School of Medicine Institutional Review Board, an independent ethics body that is compliant with the requirements of the US Code of Federal Regulations (21 CFR Part 50, 45 CFR Part 46). The DUMC IRB requires a research data security plan be submitted as part of each research application. |
| Procedures to access the database by third parties | Yes | We do not allow external access to our database but we share our data with other researchers upon request and execution of a data use agreement. A publically accessible dataset catalog is in the works |
| Access to external databases/registries | Yes | |
| Standardised process to access an external database | Yes |