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
398 application forms
424 electronic application forms
NIAID's Annotated R01
grant mechanism used by NIH to provide support for health-related research which can be investigator-initiated or in response to a program announcement or request for application.
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.
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Evidence-Based Guide to Writing Grant Proposals for Clinical
Research, (364 KB).
Inouye SK, and Fiellin DA. Ann Intern Med. 2005 Feb 15;142(4):274-82.
NIAID's NIH Grant Cycle: Application to Renewal
Consent Checklist describes required and additional
elements in consent forms by OHRP
Informed Consent Tools from Clinical Trials Networks Best Practices: NIH Roadmap provides checklists and templates for consents, parental permissions and witnesses.
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
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.
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 form for a clinical research study. It is important that you check with your local IRB
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102
and full 45 CFR 46
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
research. Also known as Informed Consent.
Institutional Review Board (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.
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
Consent Template for Cancer Treatment Trials by NCI
Data Monitoring Plan Checklist, (44 KB)
Observational and Safety Monitoring Boards (OSMB) Charter , (74 KB)
independent monitoring group whose principal role is to regularly monitor regularly data from large or complex observational studies and to review and assess the performance of its operations. Whether an OSMB is needed is determined on a case-by-case basis by NHLBI.
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
Office for Human Research Protections (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)
HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage
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 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
Clinical Research Associates Inc. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.
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
NIAID GCP Learning Center
Recruitment and Retention Resources:
AccrualNet - supports successful clinical trial accrual at each stage by providing:
- Linkable access to existing tools and materials
- A searchable, annotated list of published journal articles on clinical trial recruitment
- A space to ask questions, post tips, share experiences, insight, materials and strategies
- Training opportunities available to orient and educate new staff to successful recruitment strategies
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
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov