Glossary, CRG, NHLBI, NIH

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

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

Grant
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.

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.

An 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

Informed Consent Checklist describes required and additional elements in consent forms by OHRP

Informed Consent

Informed Consent
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.

Tools from Clinical Trials Networks Best Practices: NIH Roadmap provides checklists and templates for consents, parental permissions and witnesses.

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 form
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction

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.

for a clinical research study. It is important that you check with your local IRB

Institutional Review Board (IRB)
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).

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.

Consent Template for Cancer Treatment Trials by NCI

Data Monitoring Plan Checklist, (44 KB)

DSMB/OSMB

Observational and Safety Monitoring Boards (OSMB)
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.

Charter

, (74 KB)

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)
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.

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.

Good Clinical Practice in FDA-Regulated Clinical Trials

PharmaSchool GCP

Good Clinical Practice (GCP)
ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects. The International Conference on Harmonization has developed Guidelines for Good Clinical Practices. See also Good Clinical Practice in FDA-Regulated Clinical Trials.

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
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.

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

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

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CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management How do I comply with Good Clinical Practices (GCP)? How do I manage changes to my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor subject recruitment/retention? How do I report adverse events? How is data quality monitored? What if I wish to add extra sites or studies to my project? How do I manage my budget and when are reports expected? What is HIPAA and how do I abide by the requirements ? Study Closure Tools & Training Glossary	Toolkit Resource 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 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 Grant 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. 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. An 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 Informed Consent Checklist describes required and additional elements in consent forms by OHRP Informed Consent Informed Consent a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research. Tools from Clinical Trials Networks Best Practices: NIH Roadmap provides checklists and templates for consents, parental permissions and witnesses. 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 form a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects Human Subject Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 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. for a clinical research study. It is important that you check with your local IRB Institutional Review Board (IRB) 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). 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. Consent Template for Cancer Treatment Trials by NCI Data Monitoring Plan Checklist, (44 KB) DSMB/OSMB Observational and Safety Monitoring Boards (OSMB) 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. Charter , (74 KB) 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) 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. 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. Good Clinical Practice in FDA-Regulated Clinical Trials PharmaSchool GCP Good Clinical Practice (GCP) ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects. The International Conference on Harmonization has developed Guidelines for Good Clinical Practices. See also Good Clinical Practice in FDA-Regulated Clinical Trials. 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 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. 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 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
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