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St. Jude and World Health Organization are creating a platform that will transform access to childhood cancer medicines around the world.
Registry
Overview
The SJCARES Registry tool is a hospital-based pediatric cancer registration and reporting system. Using an intuitive and secure cloud-based platform, the tool is designed specifically for low- and middle-income country contexts so that only relevant information is collected.
All data is owned by the individual member hospitals. St. Jude provides central quality control and assurance, along with easy reporting, to support population-based cancer registries.
SJCARES Registry provides opportunities to engage with and grow the registry and participate in global research.
Registry Tool
The Registry tool is a cloud-based solution for collecting pediatric hospital-based cancer registry data. The tool works with all major modern internet browsers and has proved functional in many countries, even with slow internet connections.
Watch a demonstration:
Why Use the Registry?
This is the first free, secure and thoughtfully crafted pediatric hospital-based cancer registry. It offers a standardized global platform, with only necessary data collected.
All data is owned by the individual member hospitals.
In addition:
- St. Jude can provide central quality control and quality assurance.
- There are opportunities to engage with and grow the registry together.
- The registry features easy reporting to support population-based cancer registries.
- There are chances to participate passively and actively in SJCARES global research.
Registry Content
The Registry tool set includes three registration modules that make up the global hospital-based childhood cancer network, with hospitals joining the SJCARES Registry within the six World Health Organization (WHO) regions, where the Core Registry is available now. The Extended Registry and Adverse Events Module will be launched soon.
The SJCARES Registry will grow as an institution's data needs and capacity for data entry grow.
The tool was designed to support a hospital workflow in busy hospitals where data entry support is limited.
Responding to hospital registration needs, the first sibling registry, FEVEREG, is now available as part of the Registry ecosystem. This tool help with the surveillance of febrile episodes in low-and-middle-income country hospitals.
Data Ownership and Collection
All data is contractually owned by the individual member hospitals. Local registry teams can download their data at any time into one of several file formats for quality improvement or research purposes. St. Jude stipulates that any time the data is used for publication, all local ethics review procedures be followed.
SJCARES Registry provides opportunities for all St. Jude Global Alliance members to engage with registry data and participate in global research. As part of a data-use agreement, St. Jude will de-identify and store the data as part of the SJCARES data warehouse. Any investigator from a participating hospital may propose and conduct research that uses these de-identified data sets in accordance with the policies and procedures of the St. Jude Global Alliance. Whenever data from a hospital is used in a St. Jude Global Alliance study, a minimum of one investigator from the hospital will be eligible for co-authorship on any resulting publication.
Designed to Provide Global Standards
The SJCARES Registry:
- Is the product of a multidisciplinary effort with input from collaborators in every St. Jude Global Alliance region.
- Addresses a need for global standards to support pediatric hospital-based cancer registries.
- Allows hospitals to collect data to improve the quality of care at the local level and to share data with population-based registries at the national level.
The Registry team has taken an iterative design approach to ensure that the system meets the needs of users.
Careful consideration was given to ensuring that the data collected is the key data hospitals need for making, and tracking the impact of, important decisions. Examples include:
- ICD-O-3 coding and Toronto Consensus staging criteria
- Basic treatment data capture
- Follow-up and abandonment tracking
Data Security and Privacy
The physical servers for SJCARES Registry are securely maintained. Data is protected through a series of measures, including point-to-point encryption, data server encryption and data segmentation. St. Jude provides regular external audits of physical and logical security measures and practices in the data center. Protected health information is not viewable by St. Jude staff. The registry was built using OmniComm TrialMaster, an external third party.
SJCARES Registry uses industry best practices:
- Meets U.S. FDA and European GDPR requirements
- Uses the Microsoft Azure platform to manage identity and access
- Requires second-factor authentication by phone, email, text or application
St. Jude de-identifies the data in the SJCARES databank. Members can apply for data access to conduct a global or regional study. After the St. Jude Global Alliance steering committee reviews and approves the study, members are provided with access to the data and support for publication.
Registry Educational Curriculum
SJCARES Registry also provides educational resources.
Training Curriculum for Pediatric Cancer Registration
To provide a scalable solution for the initial and continuing education of learners who work with pediatric cancer registries in low- and middle-income country settings, the Registry team developed an asynchronous, competency-based education curriculum.
- A design-based research approach allowed for iterative cycles of revision and refinement of instructional material. This approach included:
- A scoping review of available cancer registration training materials
- Formulation of core competencies and learning objectives grouped hierarchically as modules and lesson plans to form a syllabus
- Development of course content and assessment questions through a three-stage iterative, peer-review process.
- A clinical research associate develops the initial content.
- Educators and pediatric oncologists review the content.
- A global panel of pediatric cancer registry experts provides feedback on the content.
- Breakdown of the cancer registration curriculum:
- Tutorial on effectively navigating the database system, TrialMaster
- Cancer registration course pathway
- Before accessing the registry, every user must complete the SJCARES Registry training in the onboarding process.
- A shorter version of the registry training is available for educational purposes only. This will be freely available.
- Completing this abbreviated version does NOT qualify a user to use the SJCARES Registry; to use the registry, users must go through the seven-step onboarding process.
Cure4Kids
Cure4Kids, an initiative of the St. Jude Children's Research Hospital Department of Global Pediatric Medicine, is an online resource for health care professionals around the globe who focus on life-threatening childhood diseases. Cure4Kids enables the web-based SJCARES Registry curriculum to be freely accessible to registered users.
Registry Training Specifics
MD Monitor (must be a physician)
- Data Abstraction Course, Intro to Pediatric Oncology Module: Optional
- Data Abstraction Course, Intro to Clinical Data Abstraction Module: Optional
- Cancer Registration Course: Required
- TM Training Tutorial: Required
Data Entry Specialist with medical (MD/RN) professional background
- Data Abstraction Course, Intro to Pediatric Oncology Module: Optional
- Data Abstraction Course, Intro to Clinical Data Abstraction Module: Required
- Cancer Registration Course: Required
- TM Training Tutorial: Required
Data Entry Specialist without medical background
- Data Abstraction Course, Intro to Pediatric Oncology Module: Required
- Data Abstraction Course, Intro to Clinical Data Abstraction Module: Required
- Cancer Registration Course: Required
- TM Training Tutorial: Required
Steps for Using the Registry
There are seven key steps for joining the registry platform.
For Hospital Institution Delegates
1. Complete and sign the St. Jude Global Alliance membership agreement.
2. Sign the SJCARES Registry Data Use/Transfer Agreement.
For the Registry Director
3. Submit one registry site worksheet online.
For All Registry Team Members
4. Fill out the registry access request form online.
5. Complete the Cure4Kids training online.
6. Enter test case data in the testing environment.
7. Complete an onboarding WebEx conference call with St. Jude.
Registry Site Team Roles (English)
Función de roles del equipo del Registro
Our Team
Core Registry Development:
Nickhill Bhakta, MD, MPH
Program Director
Co-Director, ARIA Program
Director, Sub-Saharan Africa Regional Program
Director, Disease Burden and Simulation Program
Associate Member, St. Jude Faculty
Carlos Rodriguez-Galindo, MD
Executive Vice President
Chair, Department of Global Pediatric Medicine
Director, St. Jude Global
Paula Naidu, MPH, CCRP
Director, Clinical Trials Management
Lane Faughnan, BSN, CCRP
Manager, Clinical Research Operations
Gia Ferrara, MSGH
Clinical Research Associate, Research Operations
Carlton Bradley
Programmer, Clinical Research Informatics
Beta Testing:
Phase I:
Phase II:
Registry Collaborative Working Group:
Nickhill Bhakta, MD, MPH
Director, Disease Burden and Simulation
St. Jude Global Pediatric Medicine
Memphis, Tennessee, USA
Joanne Aitken, BSc (Hon), MSc, PhD
Director, Australia Childhood Cancer Registry
Cancer Council Queensland
Brisbane, Australia
Soad Linneth Fuentes Alabi, MD, MPH
Benjamin Bloom Children’s Hospital
San Salvador, El Salvador
Carlton Bradley
Programmer, Clinical Research Systems
St. Jude Children’s Research Hospital
San Diego, California, USA
Lane Faughnan, BSN, CCRP
Senior Coordinator, Research Operations
St. Jude Global Pediatric Medicine
Memphis, Tennessee, USA
Gia Ferrara, MSGH
Clinical Research Associate, SJCARES Registry
St. Jude Global Pediatric Medicine
Memphis, Tennessee, USA
Tezer Kutluk, MD, PhD, FAAP
Hacettepe University
Department of Medicine and Cancer Institute
Ankara, Turkey
Paula Naidu, MPH, CCRP
Director, Clinical Trials Management
St. Jude Global Pediatric Medicine
Memphis, Tennessee, USA
Karina Braga Ribeiro, DDS, PhD
Santa Casa de São Paolo
Department of Medical Sciences and Public Health
São Paolo, Brazil
Yayra Tuprah, BSc
Director, Clinical Research Systems
St. Jude Children’s Research Hospital
Memphis, Tennessee, USA
Danny Youlden, BSc
Biostatistician, Australian Childhood Cancer Registry
Cancer Council Queensland
Brisbane, Australia
Carlos Rodriguez-Galindo, MD
Chair, Global Pediatric Medicine
St. Jude Children’s Research Hospital
Memphis, Tennessee, USA