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Toolkit ResourceYou may find the following resources helpful in initiating and managing your clinical research study, especially if you are conducting a multi-center study. Multi-center studies require additional administrative oversight and can benefit from standardization of consent forms and adverse event reports or obtaining agreement on publication policies or data dissemination. Application Submission Tools PHS 398 application forms SF 424 electronic application forms NIAID's Annotated R01 An
Evidence-Based Guide to Writing Grant Proposals for Clinical
Research, (364 KB). NIAID's NIH Grant Cycle: Application to Renewal Informed Consent Checklist describes required and additional elements in consent forms by OHRP Informed Consent Group Health Research Institute created the PRISM Readability Toolkit , (496 KB) to help research teams develop study materials that participants can easily read and understand in "plain language," that describes exactly what the reader needs to know without using unnecessary or overly complex words. Templates Conflict of Interest Disclosure for Investigators involved in a study, (34 KB) Consent Form Template, (60 KB) - will assist you in creating a consent form Consent Template for Cancer Treatment Trials by NCI Data Monitoring Plan Checklist, (44 KB) DSMB/OSMB Evaluation Tool to assess Clinical Sites, (212 KB) Evaluation Tool to assess a Data Coordinating Center, (53 KB) Manual of Operations for Policies and Procedures in a multi-center study or Network, (29 KB) Protocol Template,(168 KB) - will assist you in developing a protocol for a clinical study. Information can be easily deleted or added to the document. When changing information, the user will need to go back to the Table of Contents, right click anywhere on the Table and choose "Update Field" in order for the document to readjust the outline numbers and to renumber the pages. Additional Toolkit Resources Clinical Trials Networks Best Practices: NIH Roadmap offers some additional resources to aid investigators in the conduct of their studies. Human Subjects Protection Many institutions have a training program for research personnel conducting research at their institution. The NIH Office of Extramural Research (OER) provides a free tutorial, web-based course called Protecting Human Research Participants that satisfies the human subjects training requirement for obtaining NIH awards. Once either course is completed, a certificate can be printed for inclusion in your grant file. "Investigator 101" is a CD ROM available from OHRP Good Clinical Practice Good Clinical Practice, (380 KB) is a set of rules and regulations that is provided by International Conference on Harmonisation - an international body that regulates clinical trials involving human subjects. The guidelines discuss protection of human rights as a subject in a clinical trial and provide guidance on how clinical trials should be conducted. Good Clinical Practice in FDA-Regulated Clinical Trials PharmaSchool GCP Clinical Researchs Training Opportunities CC-Duke Training Program in Clinical Research leads to a Master of Health Sciences in Clinical Research, a professional degree awarded by the Duke University School of Medicine. There is also a non-degree option for qualified students who want to pursue specific areas of interest. Society of Clinical Research The Society for Clinical Data Management is a non-profit, professional society founded to advance the discipline of Clinical Data Management. The binding interest of all members is quality clinical data management practices. The Society for Clinical Trials is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies. Public Responsibility in Medicine and Research (PRIM&R) is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings. Good Clinical Practice Training
Good Clinical Practice training module from CTN Best Practices Recruitment and Retention Resources: AccrualNet - supports successful clinical trial accrual at each stage by providing:
ResearchMatch is a Clinical and Translational Science Awards (CTSA) initiative funded by the National Center for Research Resources, part of the National Institutes of Health. ResearchMatch aims to serve as an effective, useful and complementary recruitment tool that will help connect willing volunteers with researchers who are searching for appropriate volunteers to be placed in their research studies (not just clinical trials). NIH Clinical Trials and You is an NIH site created to raise public awareness of clinical trials by displaying print material specifically designed for the NIH clinical research initiative. Page Last Updated: January 2012 |
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