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You 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 Grant Application and Summary Statement provides an example of a well written basic science application which may be helpful to applicants writing clinical research applications as well.
Evidence-Based Guide to Writing Grant Proposals for Clinical
Research, (364 KB).
Informed Consent Checklist describes required and additional elements in consent forms by OHRP
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.
Consent Form Template, (60 KB) - will assist you in creating a consent form for a clinical research study. It is important that you check with your local IRB to see if they have their own requirements for a particular format. The Code of Federal Regulations requires that certain elements be contained in the form. This template includes those basic elements and several others that may enhance the study participant's understanding of the research.
Data Monitoring Plan Checklist, (44 KB)
DSMB/OSMB Charter , (74 KB)
Evaluation Tool to assess Clinical Sites, (212 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.
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 to institutions that have a Federal wide Assurance (FWA) or a Multiple Project Assurance (MPA). The CD-ROM was produced by the Public Responsibility in Medicine and Research (PRIM&R) and has been professionally produced and edited to provide education on the responsible conduct of human research and protection of human subjects. It is a remarkable educational tool that provides a combination of interactive features such as, speaker slide presentations, transcripts, ethical and research guidelines, and federal regulatory documents. Contact your organization to review the CD or you may order a copy from OHRP. Ordering information is found here at the following link: http://www.hhs.gov/ohrp/references/cdrom.pdf , (27 KB)
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.
PharmaSchool GCP Challenges offers brief quizzes to assess your knowledge on a number of GCP related topics such as Informed Consent and Adverse Events.
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 Associates Inc. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.
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
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