Glossary
Screen Failure
screened participant determined to be ineligible for enrollment because they do not meet the eligibility criteria, or other requirements for research participation.
See also:Screening
a 'pre-enrollment' activity used to determine eligibility. Screening procedures are necessary solely for the purpose of determining eligibility.
See also:Serious Adverse Event
any adverse event that: 1) results in death; OR 2) is life-threatening (places the subject at immediate risk of death from the event as it occurred); OR 3) results in inpatient hospitalization or prolongation of existing hospitalization; OR 4) results in a persistent or significant disability/incapacity; OR 5) results in a congenital anomaly/birth defect; OR 6) based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
See also:Serious Noncompliance
noncompliance that may: adversely affect subject safety or the safety of others; increase risks to subjects; violate the rights and welfare of participants (any of which may also be an unanticipated problem). Serious noncompliance may affect the subject's willingness to participate in research or may affect the integrity of the data (which may also be scientific misconduct). The unfounded classification of a serious adverse event as anticipated constitutes serious non-compliance.
See also:Service Provider
a clinical department, clinic , hospital or provider who has agreed to perform specific procedures outlined in the study plan (e.g., imaging by radiology or consults with specialists).
Significant Deficiency
a deficiency that in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals.
Significant Risk Device
as a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
See also:sIRB
The single IRB (sIRB) policy is a NIH policy that applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site non-exempt human subjects research. The policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites.
See also:Site Evaluation Visit
a sponsor visit to evaluate a performance site/investigator resources and capabilities to conduct a study in terms of site infrastructure, adequacy and availability of the site facilities
See also:Site Initiation Visit
A meeting requested by the sponsor of a newly approved/activated trial for the study team at the clinical site to review the specifics (e.g.: the science, design, procedures, CRF completion etc.) of the protocol in preparation to enroll the first subject.
Source Document
Source documents are original documents, data, or records that are created during a clinical study, that relates to the medical treatment and the history of the participant, and from which study data are obtained. Source documents are one type of essential document that is required by GCP guidelines.
e.g., hospital records, clinic and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial.
Sponsor
are the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. The term sponsor is understood to include any intermediaries, such as contract research organizations or coordinating centers, acting as agents of the sponsor in carrying out the responsibilities above. All research falling under these types of agreements is considered sponsored research. In FDA regulated research, the Sponsor is the entity who takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. The intent of the sponsor's IND/IDE is to allow testing for marketing approval of the drug or device. These are generally considered commercial or corporate IND/IDEs.
Sponsor Monitoring
Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA. FDA’s regulations require sponsors to monitor the conduct and progress of their clinical investigations. The regulations are not specific about how sponsors are to conduct such monitoring and are therefore compatible with a range of approaches to monitoring that will vary depending on multiple factors. Monitoring activities include communication with the PI and study site staff; review of the study site’s processes, procedures, and records; and verification of the accuracy of data submitted to the sponsor.
See also:Sponsor-Investigator
is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug/device is being administered, used or dispensed. For administrative reasons, only one individual should be designated as the sponsor. Usually, the intent of the sponsor-investigator IND/IDE is to gain scientific knowledge without seeking market approval for the drug or device. These are considered 'Investigator-Initiated' or sponsor-investigator IND/IDEs.
See also:Sponsor-Investigator IND/IDE
There are three general categories: 1) new drug/device developed by the investigator, OR 2) new uses, new routes of administration, new dosages, or new patient populations for currently approved drugs, OR 3) new use of a significant risk device that has either been cleared under 510 (k) or approved under a Premarket Approval (PMA).
Standard Care
care or procedures that are routinely or typically provided absent a research study. (Also called generally accepted practice, routine or conventional care)
See also:Standard Practice
care or procedures that are routinely or typically provided absent a research study. (Also called generally accepted practice, routine or conventional care)
Study Operations Center
study operations centers are designed to assist the study PI in meeting the oversight responsibility of the entire project.
Subject Statuses
used to track the various states (milestones) in a subject's trajectory through a research study. The HSC's Clinical Trial Management System (CTMS) recognizes the following statuses for use in all types of clinical research (not just clinical trials): Identified/Referred Did Not Consent Consent Signed Pre-Screen Pre-Screen Failure Screening/Eligibility Screen Failure Re-screening Enrolled Active Observations Run In/Wash Out Active Treatment (intervention) Follow-Up As Planned Intervention Stopped Early - following Intervention Stopped Early - following-up complete Withdrawn Completed
See also:Substantial Impairment
of physical or physiologic Function: the circumstance where the animal is not expected to be normal after a reasonable postoperative recovery period. Examples include, but are not be limited to those procedures permanently and significantly affecting ambulation, physiology, the immune system, and mentation.
Substantive Changes
any change or request for additional information required by the IRB that is directly relevant to the determinations required to approve research 45 CFR 46.111.
Substantive Clarification
any change or request for additional information required by the IRB that is directly relevant to the determinations required to approve research 45 CFR 46.111.
Surgery
creation of a novel opening in the body or of a pre-existing orifice that involves cutting with a scalpel, scissors, biopsy forceps, punch biopsy, laser, electrocautery, or direct tissue damage by cold (liquid nitrogen) or any comparable device or technique.
See also:Surrogate Consent
when Informed Consent is obtained from a Legally Authorized Representative (LAR) consent.
See also:Survival Surgery
means that the animal recovers from anesthesia following a Surgical Procedure. See Surgery. In accordance with the AWARs and the Guide all survival surgeries require aseptic technique.
See also:Suspension of Research
a temporary cessation of some or all of the research activities by the IRB.
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