Account Administrator (AA)
- May be the same person as the signing official.
- Resides in either the central research administration office or academic departments.
- Create additional AO and PI accounts
- Not authorized to transmit applications to the NIH.
An ancillary clinical trial to a larger clinical trial may be considered an independent clinical trial if it includes an additional intervention to patients or a sub-population of patients within the larger clinical trial. An example of an ancillary study that is not a clinical trial could be research which involves analyses of stored samples collected in an ongoing clinical trial but no additional intervention to the human subjects/patients.
Animals in Research
Application Submission System & Interface for Submission Tracking (ASSIST)
Basic Experimental Studies with Humans
1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
2) Epidemiological and behavioral studies.
3) Outcomes research and health services research
Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
See Common Rule definition of research at 45 CFR 46.102(d)
See Common Rule definition of human subject at 45 CFR 46.102(f)
The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.
A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life
Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:
Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.
Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
Clinical Trial Research Experience
Cluster of Programs
Competing Research Project Grant
Conflict of Interest
Contract Transaction Types
|Type 1||New contract|
|Type 4||Letter contract|
|Type 5||Continuation of an incrementally (typically, in one year increments) funded contract|
|Type 6||Task orders and subsequent modifications relating to existing ordering agreements|
|Type 7||Exercise of option|
Cooperative Research and Development Agreement
Any agreement between one or more NIH laboratories and one or more non-Federal parties under which the PHS, through its laboratories, provides personnel, services, facilities, equipment, or other resources with or without reimbursement (but not funds to non-Federal parties) and the non-Federal parties provide funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory.
Delayed Onset Study
Early Stage Investigator (ESI)
Electronic Research Administration (eRA)
Federal Demonstration Partnership (FDP)
(1) All Federal awards which are assigned a single number in the CFDA.
(2) When no CFDA number is assigned, all Federal awards to non- Federal entities from the same agency made for the same purpose should be combined and considered one program.
(3) Notwithstanding paragraphs (1) and (2) of this definition, a cluster of programs.
The types of clusters of programs are:
(i) Research and development (R&D);
(ii) Student financial aid (SFA); and
(iii) "Other clusters,'' as described in the definition of Cluster of Programs.
Federal-Wide Assurance (FWA)
Financial Conflict of Interest
The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Examples of other grant-related activities that may be significant are:
- collaborations with investigators at a foreign site anticipated to result in co-authorship;
- use of facilities or instrumentation at a foreign site; or
- receipt of financial support or resources from a foreign entity.
An entity that is:
(1) A public or private organization located in a country other than the United States and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance;
(2) A private nongovernmental organization located in a country other than the United States that solicits and receives cash contributions from the general public;
(3) A charitable organization located in a country other than the United States that is nonprofit and tax exempt under the laws of its country of domicile and operation, and is not a university, college, accredited degree-granting institution of education, private foundation, hospital, organization engaged exclusively in research or scientific activities, church, synagogue, mosque or other similar entities organized primarily for religious purposes; or(4) An organization located in a country other than the United States not recognized as a Foreign Public Entity.