To promote clinical research that is compliant with GCP and human subject regulations, the CREST Program includes phone conversations, email consultation, and/or site visit(s) from NIMH staff, as needed, to assess and provide written feedback and recommendations on planned or ongoing clinical research protocols. The CREST Program aims to ensure that the reported clinical research study data are accurate, complete, and verifiable, the conduct of the study is in compliance with the study protocol, Good Clinical Practice (GCP) and the regulations of applicable agencies, and the rights and well-being of human subjects are protected, in accordance with 45 CFR 46 (Protection of Human Subjects) and, as applicable, 21 CFR part 50 (Protection of Human Subjects). The NIMH Clinical Research Education, Support, and Training (CREST) Program provides ongoing educational and technical support from NIMH staff for clinical research project grants selected for consultation and/or site visit(s). Clinical monitoring helps ensure the rights and well-being of human subjects are protected the reported clinical research study data are accurate, complete, and verifiable and the conduct of the study is in compliance with the study protocol, Good Clinical Practice (GCP), and the regulations of applicable agencies. This document provides a sample template for generating notes-to-file, which are written to acknowledge a discrepancy or problem with the study’s conduct, or for other administrative purposes (such as to document where study materials are stored).īack to Table of Contents On-Site MonitoringĮven though it is the NIMH’s expectation that grantees will provide adequate oversight of their clinical research, NIMH Program Officials may require additional levels of on-site monitoring conducted by NIMH staff.
#Pdf toolkit clinical trial
NIH has developed a Clinical e-Protocol Writing Tool to support the collaborative writing and review of protocols for behavioral and social sciences research involving humans, and of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. In cases where an institutional review board (IRB) has a recommended or required protocol template, reviewing the documents included below is still suggested as there may be sections that a study team may opt to include in an effort to develop a comprehensive research protocol. NIMH encourages investigators to consider using one of the protocol templates below when developing a clinical research protocol. Data and Safety Monitoring for Clinical TrialsĬlinical Research Start Up Protocol Templates.Clinical Research Education, Support, and Training (CREST) Program Overview.Regulatory Documents and Associated Case Report Forms.Nevertheless, the materials on this page can be consulted to assure that study teams are meeting NIMH expectations. In cases where institutions provide research teams with institution-specific templates and forms for clinical research documentation, NIMH expects researchers to follow their institutional policies for document use. Use of these templates and forms is optional the resources can be used as-is or customized to serve study team needs.
The Toolbox contains resources such as NIH and NIMH policy and guidance documents, templates, sample forms, links to additional resources, and other materials to assist clinical investigators in the development and conduct of high-quality clinical research studies. The NIMH Clinical Research Toolbox serves as an information repository for NIMH staff and the clinical research community, particularly those receiving NIMH funding. Research Training and Career Development Opportunities.Research Conducted at NIMH (Intramural Research Program).Upcoming Observances and Related Events.Contribute to Mental Health Research Mobile navigation
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