Protocol Support/Unique Data Sets - Resources

Please use the links below to learn more about specific research resources at the NIH Clinical Center and Intramural Program.

Office of Protocol Services

DescriptionPoint of ContactLink

The Office of Protocol Services (OPS) maintains a data repository containing protocols for the NIH Intramural Research Program (IRP) that populates data to the Clinical Center Search the Studies website, Library of Medicine ClinicalTrials.gov website and protocol consent/assent documents websites. In addition, OPS consults on issues related to the regulatory requirements for the protection of human subjects research and the Institutional Review Board (IRB) protocol requirements.

Kim Mitchell, RHIA, CIM
mitchellkjj@cc.nih.gov
301.435.2401

Protocol Authoring Tool: ProtoType

DescriptionPoint of ContactLink

Prototype is an assisted protocol authoring tool that provides a standardized template, standardizes protocol authoring while offering flexibility, offers cassette language, and facilitates the writing authoring process.

Kim Mitchell, RHIA, CIM
mitchellkjj@cc.nih.gov
301.435.2401

http://www.cc.nih.gov/about/
prototype.html

Clinical Research Data Repository
(Biomedical Translational Research Information System, BTRIS)

DescriptionPoint of ContactLink

A repository of clinical research data from across the NIH intramural programs including all hospital information and research data platforms. The goal is to interface systems with outside investigators.

Jon McKeeby, D.Sc., MBA
JMcKeeby@cc.nih.gov
301.496.3826

http://btris.nih.gov/

Infobutton Manager: A Web-Based Resource Linking Information Systems and Relevant Online Medical Knowledge Resources

DescriptionPoint of ContactLink

Being developed by the National Library of Medicine and the Clinical Center, Infobutton Manager is a Web-based resource that handles requests from the evoking system, selects appropriate resource links from its knowledge base and returns them to the user. Infobuttons are standard (HL7) context-aware links between information systems and relevant online medical knowledge resources. They have tremendous potential for bringing health information to the point of care to support evidence-based practice.

Jon McKeeby, D.Sc., MBA
JMcKeeby@cc.nih.gov
301.496.3826

Librarian Infobutton Tailoring Environment (LITE) to Assist Librarians to Identify User Information Needs

DescriptionPoint of ContactLink

Though Infobuttons have tremendous potential for bringing health information to the point of care to support evidence-based practice, informatics research has shown that significant effort is needed to tailor the Infobutton links so that they deliver appropriate information to patients and their care providers. Under development by the National Library of Medicine and the Clinical Center, the Librarian Infobutton Tailoring Environment (LITE) is a free, Web-based resource that will empower medical librarians (or their proxies) to identify the information needs of the users in their institutions.

Jon McKeeby, D.Sc., MBA
JMcKeeby@cc.nih.gov
301.496.3826

NCI Protocol Support Office

DescriptionPoint of ContactLink

The NCI Protocol Support Office provides reg ulatory support to investigators by assisting with writing protocols & amendments, and processing all submissions for IRB review. In addition, the PSO assists with writing & compiling applications to regulatory agencies such as the FDA, OBA, and the IBC.

Nicole Grant
grantn@mail.nih.gov
301.272.0476

https://ccrod.cancer.gov/
confluence/display/CCRCRO/
Protocol+Support+Office

NICHD Clinical Trials Database Project

DescriptionPoint of ContactLink

The NICHD Clinical Trials Database Project (CTDB) is a web-based application that supports data management for natural history and clinical trial research studies. The system securely provides key features for protocol study design, data collection, biospecimen tracking, and reporting. Hosted at the NICHD in Bethesda, MD, the CTDB currently supports 350 research protocols across 12 NIH Institutes: NICHD, NIMH, NINR, NIDDK, NIDCR, CC, NIEHS, NIAMS, NHGRI, NCATS, NIAAA and NHLBI.

Forbes Porter , M.D.
fdporter@mail.nih.gov
301.435.4432
Asma Idriss
idrissa@mail.nih.gov
301.496.1258

NIDCR Clinical Research Core Protocol Services

DescriptionPoint of ContactLink

The NIDCR Clinical Research Core conducts varied clinical and translational research projects and offers oral medicine and dental consultation services for the unique Clinical Center patient population. The Clinical Research Core supports clinical research through assistance with protocol writing, scientific reviewing, regulatory compliance (FDA and OHRP), database development, AE/SAE reporting, subject scheduling, study coordinator support and research nursing support.

James Melvin, DDS, Ph.D.
melvinje@mail.nih.gov
301.402.1706

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This page was last updated: 01/26/2017