HPCIO has been developing a clinical care and research data management system to allow physicians and clinicians to conduct clinical trials and researches. The Clinical Informatics and Management System (CIMS) is a centralized clinical data management and analysis system that will assist NIH clinical investigators in managing protocols and patient and research data as well as in integrating disparate data sources for analysis.
Clinical Informatics Management System (CIMS) overview schematic
Schematic representation of multi-tiered architecture
In collaboration with NINDS, HPCIO continued with the development of the CIMS, a web-based, centralized data management and analysis system that will assist clinical investigators in managing protocols, patient data, and research data.
HPCIO’s development of the Protocol Tracking and Management System (PTMS) has been completed. The final release, version 2.3, included features to support Brain IRB, improvements to the ad hoc query and export features, and other general improvements to the operation of the application. Since the time of the final release of PTMS, HPCIO’s focus on CIMS has turned towards the development of the Clinical Study Information System (CSIS).
We continued the development of CSIS to support the efficient management of clinical data and to allow clinicians to use clinical information for analyses that will lead to proper clinical care, treatment, and decision-making. CSIS has enabled a more efficient means to collect data for the study of alpha-galactosidase activity in Fabry Disease. In a phase II, multi-center, 12-week study to evaluate the safety and tolerability of multiple doses of AT1001 therapy in patients with Fabry disease, CSIS made the data more readily available and thus provided a faster means to the understanding of how certain metrics such as clinical laboratory tests (serum, chemistry, hematology, and urinalysis), electrocardiograms (ECGs), and physical examination would affected the treatment of Fabry disease with AT1001.
Three releases were completed for CSIS with features and enhancement such as, data export, patient visit schedule, interfaced to the NLM’s Unified Medical Language System (UMLS), form versioning, and creation of a study plan.
Current and Future Work
The CIMS project will support the data migration of a phase III Vietnam Head Injury Study (VHIS) onto the CSIS platform. VHIS is a longitudinal neuropsychological and medical study of Vietnam Veterans with penetrating head injury. This will be a joint collaboration between the National Naval Medical Center (NNMC), NINDS and HPCIO. One of the focuses will be on providing a vehicle for data upload to the existing study plan structure. In the Spring of 2007, a new protocol will also be established to support the collection of data for the Iraq head injury study.
Improvements to CSIS will include improving the dynamic query capability to include sub-queries and distributed queries that across multiple protocols for data discovery; creating an effective auditing mechanism for tracking accesses and changes made in the clinical database and protecting patient concerns and privacy; improving the form library re-usability such that forms can be modified and utilized across all protocols; creating a way to allow patient to fill out survey forms or other pre-admission forms over the web.
- Yang Fann, Ph.D., Director, Division of Intramural Research, NINDS
- Jordan Grafman, Ph.D., Senior Investigator, Chief, Cognitive Neuroscience Section, NINDS
- Michael C Tierney, M.A., Patient Coordinator, Cognitive Neuroscience Section, NINDS
- Alyson Cavanagh, B.S., Research Assistant, Cognitive Neuroscience Section, NINDS
- Raphael Schiffmann, M.D., Staff Clinician, Developmental and Metabolic Neurology Branch, NINDS
- Chevalia Robinson, R.N., Developmental and Metabolic Neurology Branch, NINDS
- Michelle Ashmus, R.N., Clinical Trials Coordinator, Developmental and Metabolic Neurology Branch, NINDS
- Lynn Carter, Clinical Research Coordinator, Developmental and Metabolic Neurology Branch, NINDS
- Mark Hallett, M.D., Senior Investigator, Chief, Human Motor Control Section, NINDS
- Elizabeth Peckham, M.D., Clinical Fellow, Human Motor Control Section, NINDS
- Henry McFarland, M.D., Senior Investigator, Clinical Director, Chief, Clinical Disease Section, NINDS
- Roger Stone, Research Assistant, Clinical Disease Section, NINDS
- John L. Ostuni, Ph.D., Staff Scientist, Clinical Neurosciences Program, NINDS
- Gladys Wang, SRA
- Amarendra Yavatkar, Ph.D., SRA
- Sandi Bonifant, Research Coordinator, Vietnam Head Injury Study, National Naval Medical Center
- Kathy Reding, Research Assistant, Vietnam Head Injury Study, National Naval Medical Center
Huey Cheung, Yang Fann, Shaohua A. Wang, Barg Upender, Adam Frazin, Raj Lingam, Sarada Chintala, Frank Pecjak, Gladys Wang, Marc Kellogg, Robert L. Martino, and Calvin Johnson
“A Web-Based Protocol Tracking Management System For Clinical Research.” 17th IEEE Symposium on Computer Based Medical Systems 24:25 June 2004 Bethesda, MD; 72-77 (2004)
Shaohua A Wang, Yang Fann, Huey Cheung, Frank Pecjak, Barg Upender, Adam Frazin, Raj Lingam, Sarada Chintala, Gladys Wang, Marc Kellogg, Robert L. Martino, and Calvin A. Johnson
“Performance of Using Oracle XMLDB in the Evaluation of CDISC ODM for a Clinical Study Informatics System.” Proceedings 17th IEEE Symposium on Computer-Based Medical Systems 24:25 June 2004 Bethesda, MD; 594-599 (2004)
Cheung H, Wang A, Fann Y, Upender B, Chinatala S, Frazin A, Nie W, Martino R L, Johnson C, “A Web-Based Clinical Research Platform for Managing Multiple Clinical Research Studies.” Poster. NIH Research Festival 2006.
- PTMS is supporting 236 protocols from four institutions namely NINDS (218), CC (3), NIDCD (14), and NICHD (1).
- There are 176 Natural History protocols, 15 phase I Clinical Trial protocols, 34 phase II Clinical Trial protocols, 1 phase III Clinical Trial protocols, 5 Screening protocols, and 5 Training protocols.
- PTMS is assisting 60 Principal Investigators in managing the protocol submission process and 700 plus other users which included: Protocol Coordinators, Associate Investigators, Accountable Investigators, Medical Advisory Investigators, Research Contacts, Administrative Contacts, Statistical Reviewers, and Primary Reviewers.
- CSIS is supporting 10 protocols, 300 patients, 200+ forms and 50 batteries (collection of forms).