Severely debilitating definition

Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
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Severely debilitating means diseases or conditions that cause major irreversible morbidity. Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and those with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival (see 21 CFR 312.81).
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Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.2. There is no standard acceptable treatment available, and3. There is not sufficient time to obtain IRB approval. BACKGROUND: Emergency Exemption from Prospective IRB Approval This exemption allows for one emergency use of a test article (or Humanitarian Use Device, or HUD) without prospective IRB review. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval. The FDA acknowledges, however, that it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the issue. The Principal Investigator should notify the IRB prior to such use whenever possible. However, this notification should not be construed as an IRB approval. The IRB does not have a role in giving “permission” prior to the use of a non-FDA approved investigational drug or device in an emergent situation. This is entirely at the discretion of the treating physician and, where indicated,the hospital pharmacy. The Investigator is still required to obtain patient informed consent even under these emergent circumstances unless it is not feasible. Notification should be used by the IRB to initiate tracking to ensure that the investigator files a report to the IRB within the five working day time-frame. The FDA regulations do not provide for expedited IRB approval in emergency situations. Therefore, "interim," "compassionate," "temporary" or other terms for an expedited approval process are not authorized. An IRB must either convene and give "full board" approval of the emergency use or, if the three conditions above are met and it is not possible to convene a quorum within the time available, the use may proceed without any IRB approval. Some manufacturers will agree to allow the use of the test article (or Humanitarian Use Device), but their policy requires "an IRB approval letter" before the test article will be shipped. If it is not possible to convene a quorum of the IRB within the time available, the IRBs may send to the sponsor a written statement that the IRB is aware of the proposed use and considers the use to meet the requirements. Although, this is not an "IRB approval," the acknowledgment letter h...
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Examples of Severely debilitating in a sentence

  • Severely debilitating means diseases or conditions that cause major irreversible morbidity.

  • Severely debilitating: diseases or conditions that cause major irreversible morbidity.

  • If crystals still do not form, take a small amount of your solution and spread it on a watch glass.

  • The Securities Administrator shall promptly notify the Company in writing of the Securities selected for redemption and, in the case of any Security selected for partial redemption, the principal amount thereof to be redeemed.

  • I 3 STRATEGY PARTNERS CONFIDENTIAL Comme r cial Oppo r tunity Multiple Syste m At r op h y Independent Ana l ysis *Does not include spontaneous use in PD Severely debilitating, fatal illnesses with no current treatments are ripe for new entrants targeting what may be the actual cause of the disease.

  • Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.o Severely debilitating means diseases or conditions that cause major irreversible morbidity.

  • We have concluded that establishing the Monitor as a departmental agency is high risk in terms of children and young people’s safety and wellbeing.

  • Rather, the subjects must be in a life- threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.2. Severely debilitating means diseases or conditions that cause major irreversible morbidity.

  • Rather, the subject must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.2. Severely debilitating: diseases or conditions that cause major irreversible morbidity.

Related to Severely debilitating

  • Habilitation means the process by which a person is assisted

  • Substantial rehabilitation means, with respect to the SAIL Program, to bring a Development back to its original state with added improvements, where the value of such repairs or improvements (excluding the costs of acquiring or moving a structure) exceeds 40 percent of the appraised as is value (excluding land) of such Development before repair and less than 50 percent of the proposed construction work consists of new construction. For purposes of this definition, the value of the repairs or improvements means the Development Cost. To be considered “Substantial Rehabilitation,” there must be at least the foundations remaining from the previous structures, suitable to support the proposed construction.

  • Severe or "extraordinary" condition is defined as serious or extreme and/or life threatening.

  • Intimidating, threatening, abusive, or harming conduct means, but is not limited to, conduct that does the following:

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Mental, Nervous or Psychological Disorder means a mental or nervous health condition including, but not limited to: anxiety, depression, neurosis, phobia, psychosis; or any related physical manifestation.

  • Autism spectrum disorder means a neuro-developmental condition typically appearing in the first three years of life that significantly affects a person's ability to communicate, understand relationships and relate to others, and is frequently associated with unusual or stereotypical rituals or behaviours.

  • Deaf/blindness means concomitant hearing and visual impairments, the combination of which causes such severe communication and other developmental and educational problems that they cannot be accommodated in special education programs solely for students with deafness or students with blindness.

  • Behavioral health disorder means either a mental disorder

  • REASONABLY SAFE FROM FLOODING Means base flood waters will not inundate the land or damage structures to be removed from the floodplain and that any subsurface waters related to the base flood will not damage existing or proposed buildings.

  • Habilitative services means those services provided by

  • Mysterious Disappearance means any disappearance of Property which, after a reasonable investigation has been conducted, cannot be explained.

  • Rehabilitation services means face-to-face individual or group services provided by qualified staff to develop skill necessary to perform activities of daily living and successful integration into community life.

  • Diagnosis of autism spectrum disorder means medically necessary assessments, evaluations, or tests

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Vocational rehabilitation services means professional services reasonably necessary during or after, or both during and after, medical treatment to enable a disabled injured employee to return to gainful employment as soon as practical. "Vocational rehabilitation services" includes vocational evaluation, retraining and job placement.

  • Inherited Metabolic Disorder means a disease caused by an inherited abnormality of body chemistry that meets all of the following requirements:

  • Serious means violations that either result in one or more neg- ative outcomes and significant actual harm to residents that does not constitute imminent danger, or there is a reasonable predictability of recurring actions, practices, situations, or incidents with potential for causing significant harm to a resident, or both.

  • Elderly means Elderly as defined in Section 420.503, F.S.

  • Serious illness means an accident, injury, illness, disease, or physical or mental condition that: poses imminent danger of death; requires inpatient care in a hospital, hospice, or residential medical facility; or requires continuing in-home care under the direction of a physician or health care provider. Related current definitions are summarized in (f) below.

  • Certified rehabilitation means any rehabilitation of a certified historic structure

  • Safeguarding and promoting the welfare of children means: • Protecting children from maltreatment• Preventing impairment of children’s mental or physical health or development• Ensuring that children grow up in circumstances consistent with the provision of safe and effective care• Taking action to enable all children to have the best outcomes

  • Rehabilitative services means specialized services provided by a therapist or a therapist’s assistant to a resident to attain optimal functioning, including, but not limited to, physical therapy, occupational therapy, speech and language therapy, and audiology.

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  • Rehabilitation Hospital means an Institution which mainly provides therapeutic and restorative services to Sick or Injured people. It is recognized as such if:

  • Rehabilitation means the repair, renovation, alteration or reconstruction of any building or structure, pursuant to the Rehabilitation Subcode, N.J.A.C. 5:23-6.