Email address of person completing form:
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Is this an Expanded Access use drug (IND) or device (IDE) application?
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Drug (IND) Device (IDE)
Is this an Expanded Access request for a single patient or multiple patients?
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Single patient More than one patient
COMIRB Protocol Number:
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Protocol Title:
IND/IDE Format: "Single Patient IND/IDE for [DRUG/DEVICE], IND/IDE# [IND#/IDE#], Patient [PT INITIALS]"
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Is this for treatment of a Cancer Center patient?
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No
Yes
For OnCore Library
Patient Initials
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Adult Child
Investigational Drug/Device Name
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Name of the entity that will supply the drug/device (generally the manufacturer ):
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OnCore Sponsor
Is the IDE held by the manufacturer or a physician?
Manufacturer
Physician
Have you discussed, with the patient, the cost of this device to the patient?
Yes
No
Be advised that insurance may not cover the cost of the device. Please discuss this with your patient.
Disease ICD-10 Code
* must provide value
A15: Respiratory tuberculosis A17: Tuberculosis of nervous system A18: Tuberculosis of other organs A19: Miliary tuberculosis A22: Anthrax A48: Other bacterial diseases, not elsewhere classified A69: Other spirochetal infections A79: Other rickettsioses A81: Atypical virus infections of central nervous system A88: Oth viral infections of central nervous system, NEC A98: Other viral hemorrhagic fevers, not elsewhere classified B00: Herpesviral [herpes simplex] infections B08: Oth viral infect with skin and mucous membrane lesions, NEC B10: Other human herpesviruses B19: Unspecified viral hepatitis B33: Other viral diseases, not elsewhere classified B34: Viral infection of unspecified site B48: Other mycoses, not elsewhere classified B66: Other fluke infections B71: Other cestode infections B83: Other helminthiases B88: Other infestations B99: Other and unspecified infectious diseases C00: Malignant neoplasm of lip C01: Malignant neoplasm of base of tongue C02: Malignant neoplasm of other and unspecified parts of tongue C03: Malignant neoplasm of gum C04: Malignant neoplasm of floor of mouth C05: Malignant neoplasm of palate C06: Malignant neoplasm of other and unspecified parts of mouth C07: Malignant neoplasm of parotid gland C08: Malignant neoplasm of other and unsp major salivary glands C09: Malignant neoplasm of tonsil C10: Malignant neoplasm of oropharynx C11: Malignant neoplasm of nasopharynx C12: Malignant neoplasm of pyriform sinus C13: Malignant neoplasm of hypopharynx C14: Malig neoplasm of sites in the lip, oral cavity and pharynx C15: Malignant neoplasm of esophagus C16: Malignant neoplasm of stomach C17: Malignant neoplasm of small intestine C18: Malignant neoplasm of colon C19: Malignant neoplasm of rectosigmoid junction C20: Malignant neoplasm of rectum C21: Malignant neoplasm of anus and anal canal C22: Malignant neoplasm of liver and intrahepatic bile ducts C23: Malignant neoplasm of gallbladder C24: Malignant neoplasm of other and unsp parts of biliary tract C25: Malignant neoplasm of pancreas C26: Malignant neoplasm of other and ill-defined digestive organs C30: Malignant neoplasm of nasal cavity and middle ear C31: Malignant neoplasm of accessory sinuses C32: Malignant neoplasm of larynx C33: Malignant neoplasm of trachea C34: Malignant neoplasm of bronchus and lung C37: Malignant neoplasm of thymus C38: Malignant neoplasm of heart, mediastinum and pleura C39: Malig neoplm of sites in the resp sys and intrathorac organs C40: Malignant neoplasm of bone and articular cartilage of limbs C41: Malignant neoplasm of bone/artic cartl of and unsp sites C43: Malignant melanoma of skin C4A: Merkel cell carcinoma C44: Other and unspecified malignant neoplasm of skin C45: Mesothelioma C46: Kaposi's sarcoma C47: Malignant neoplasm of prph nerves and autonomic nervous sys C48: Malignant neoplasm of retroperitoneum and peritoneum C49: Malignant neoplasm of other connective and soft tissue C50: Malignant neoplasm of breast C51: Malignant neoplasm of vulva C52: Malignant neoplasm of vagina C53: Malignant neoplasm of cervix uteri C54: Malignant neoplasm of corpus uteri C55: Malignant neoplasm of uterus, part unspecified C56: Malignant neoplasm of ovary C57: Malignant neoplasm of other and unsp female genital organs C58: Malignant neoplasm of placenta C60: Malignant neoplasm of penis C61: Malignant neoplasm of prostate C62: Malignant neoplasm of testis C63: Malignant neoplasm of other and unsp male genital organs C64: Malignant neoplasm of kidney, except renal pelvis C65: Malignant neoplasm of renal pelvis C66: Malignant neoplasm of ureter C67: Malignant neoplasm of bladder C68: Malignant neoplasm of other and unspecified urinary organs C69: Malignant neoplasm of eye and adnexa C70: Malignant neoplasm of meninges C71: Malignant neoplasm of brain C72: Malig neoplm of spinal cord, cranial nerves and oth prt cnsl C73: Malignant neoplasm of thyroid gland C74: Malignant neoplasm of adrenal gland C75: Malignant neoplasm of endo glands and related structures C7A: Malignant neuroendocrine tumors C7B: Secondary neuroendocrine tumors C76: Malignant neoplasm of other and ill-defined sites C77: Secondary and unspecified malignant neoplasm of lymph nodes C78: Secondary malignant neoplasm of resp and digestive organs C79: Secondary malignant neoplasm of other and unspecified sites C80: Malignant neoplasm without specification of site C81: Hodgkin lymphoma C82: Follicular lymphoma C83: Non-follicular lymphoma C84: Mature T/NK-cell lymphomas C85: Oth and unspecified types of non-Hodgkin lymphoma C86: Other specified types of T/NK-cell lymphoma C88: Malig immunoproliferative dis and certain oth B-cell lymph C90: Multiple myeloma and malignant plasma cell neoplasms C91: Lymphoid leukemia C92: Myeloid leukemia C93: Monocytic leukemia C94: Other leukemias of specified cell type C95: Leukemia of unspecified cell type C96: Oth & unsp malig neoplm of lymphoid, hematpoetc and rel tiss D45: Polycythemia vera D46: Myelodysplastic syndromes D47: Oth neoplm of uncrt behav of lymphoid, hematpoetc & rel tiss D49: Neoplasms of unspecified behavior D55: Anemia due to enzyme disorders D56: Thalassemia D57: Sickle-cell disorders D58: Other hereditary hemolytic anemias D59: Acquired hemolytic anemia D61: Oth aplastic anemias and other bone marrow failure syndromes D68: Other coagulation defects D69: Purpura and other hemorrhagic conditions D72: Other disorders of white blood cells D73: Diseases of spleen D75: Other and unsp diseases of blood and blood-forming organs D76: Oth dis with lymphoreticular and reticulohistiocytic tissue D80: Immunodeficiency with predominantly antibody defects D81: Combined immunodeficiencies D83: Common variable immunodeficiency D84: Other immunodeficiencies D86: Sarcoidosis D89: Oth disorders involving the immune mechanism, NEC E01: Iodine-deficiency related thyroid disorders and allied cond E03: Other hypothyroidism E05: Thyrotoxicosis [hyperthyroidism] E06: Thyroiditis E07: Other disorders of thyroid E10: Type 1 diabetes mellitus E11: Type 2 diabetes mellitus E13: Other specified diabetes mellitus E16: Other disorders of pancreatic internal secretion E20: Hypoparathyroidism E21: Hyperparathyroidism and other disorders of parathyroid gland E22: Hyperfunction of pituitary gland E23: Hypofunction and other disorders of the pituitary gland E27: Other disorders of adrenal gland E28: Ovarian dysfunction E29: Testicular dysfunction E32: Diseases of thymus E34: Other endocrine disorders E66: Overweight and obesity E72: Other disorders of amino-acid metabolism E74: Other disorders of carbohydrate metabolism E75: Disord of sphingolipid metab and oth lipid storage disorders E76: Disorders of glycosaminoglycan metabolism E77: Disorders of glycoprotein metabolism E78: Disorders of lipoprotein metabolism and other lipidemias E79: Disorders of purine and pyrimidine metabolism E80: Disorders of porphyrin and bilirubin metabolism E83: Disorders of mineral metabolism E84: Cystic fibrosis E85: Amyloidosis E87: Other disorders of fluid, electrolyte and acid-base balance E88: Other and unspecified metabolic disorders F01: Vascular dementia F03: Unspecified dementia F10: Alcohol related disorders F11: Opioid related disorders F12: Cannabis related disorders F13: Sedative, hypnotic, or anxiolytic related disorders F14: Cocaine related disorders F15: Other stimulant related disorders F16: Hallucinogen related disorders F17: Nicotine dependence F18: Inhalant related disorders F19: Other psychoactive substance related disorders F20: Schizophrenia F25: Schizoaffective disorders F30: Manic episode F31: Bipolar disorder F32: Major depressive disorder, single episode F33: Major depressive disorder, recurrent F34: Persistent mood [affective] disorders F40: Phobic anxiety disorders F41: Other anxiety disorders F43: Reaction to severe stress, and adjustment disorders F44: Dissociative and conversion disorders F45: Somatoform disorders F48: Other nonpsychotic mental disorders F50: Eating disorders F51: Sleep disorders not due to a substance or known physiol cond F52: Sexual dysfnct not due to a substance or known physiol cond F55: Abuse of non-psychoactive substances F60: Specific personality disorders F63: Impulse disorders F64: Gender identity disorders F65: Paraphilias F68: Other disorders of adult personality and behavior F80: Specific developmental disorders of speech and language F81: Specific developmental disorders of scholastic skills F84: Pervasive developmental disorders F90: Attention-deficit hyperactivity disorders F91: Conduct disorders F93: Emotional disorders with onset specific to childhood F94: Disord social w onset specific to childhood and adolescence F98: Oth behav/emotn disord w onset usly occur in chldhd and adol G00: Bacterial meningitis, not elsewhere classified G03: Meningitis due to other and unspecified causes G04: Encephalitis, myelitis and encephalomyelitis G06: Intracranial and intraspinal abscess and granuloma G11: Hereditary ataxia G12: Spinal muscular atrophy and related syndromes G23: Other degenerative diseases of basal ganglia G24: Dystonia G25: Other extrapyramidal and movement disorders G30: Alzheimer's disease G31: Oth degenerative diseases of nervous system, NEC G37: Other demyelinating diseases of central nervous system G40: Epilepsy and recurrent seizures G43: Migraine G44: Other headache syndromes G45: Transient cerebral ischemic attacks and related syndromes G46: Vascular syndromes of brain in cerebrovascular diseases G47: Sleep disorders G50: Disorders of trigeminal nerve G51: Facial nerve disorders G52: Disorders of other cranial nerves G54: Nerve root and plexus disorders G56: Mononeuropathies of upper limb G57: Mononeuropathies of lower limb G58: Other mononeuropathies G60: Hereditary and idiopathic neuropathy G61: Inflammatory polyneuropathy G62: Other and unspecified polyneuropathies G70: Myasthenia gravis and other myoneural disorders G71: Primary disorders of muscles G72: Other and unspecified myopathies G80: Cerebral palsy G81: Hemiplegia and hemiparesis G82: Paraplegia (paraparesis) and quadriplegia (quadriparesis) G83: Other paralytic syndromes G90: Disorders of autonomic nervous system G91: Hydrocephalus G93: Other disorders of brain G95: Other and unspecified diseases of spinal cord G98: Other disorders of nervous system not elsewhere classified H04: Disorders of lacrimal system H05: Disorders of orbit H15: Disorders of sclera H18: Other disorders of cornea H21: Other disorders of iris and ciliary body H25: Age-related cataract H26: Other cataract H27: Other disorders of lens H31: Other disorders of choroid H33: Retinal detachments and breaks H34: Retinal vascular occlusions H35: Other retinal disorders H40: Glaucoma H43: Disorders of vitreous body H44: Disorders of globe H46: Optic neuritis H47: Other disorders of optic [2nd] nerve and visual pathways H50: Other strabismus H51: Other disorders of binocular movement H52: Disorders of refraction and accommodation H55: Nystagmus and other irregular eye movements H57: Other disorders of eye and adnexa H61: Other disorders of external ear H69: Other and unspecified disorders of Eustachian tube H71: Cholesteatoma of middle ear H73: Other disorders of tympanic membrane H74: Other disorders of middle ear mastoid H80: Otosclerosis H81: Disorders of vestibular function H83: Other diseases of inner ear H90: Conductive and sensorineural hearing loss H93: Other disorders of ear, not elsewhere classified I01: Rheumatic fever with heart involvement I11: Hypertensive heart disease I12: Hypertensive chronic kidney disease I21: STEMI & NSTEMI mocard infrc I24: Other acute ischemic heart diseases I25: Chronic ischemic heart disease I26: Pulmonary embolism I27: Other pulmonary heart diseases I28: Other diseases of pulmonary vessels I31: Other diseases of pericardium I34: Nonrheumatic mitral valve disorders I35: Nonrheumatic aortic valve disorders I36: Nonrheumatic tricuspid valve disorders I37: Nonrheumatic pulmonary valve disorders I42: Cardiomyopathy I45: Other conduction disorders I49: Other cardiac arrhythmias I67: Other cerebrovascular diseases I70: Atherosclerosis I71: Aortic aneurysm and dissection I72: Other aneurysm I73: Other peripheral vascular diseases I74: Arterial embolism and thrombosis I75: Atheroembolism I77: Other disorders of arteries and arterioles I78: Diseases of capillaries I80: Phlebitis and thrombophlebitis I82: Other venous embolism and thrombosis I83: Varicose veins of lower extremities I85: Esophageal varices I86: Varicose veins of other sites I87: Other disorders of veins I89: Oth noninfective disorders of lymphatic vessels and nodes I95: Hypotension I99: Other and unspecified disorders of circulatory system J34: Other and unspecified disorders of nose and nasal sinuses J38: Diseases of vocal cords and larynx, not elsewhere classified J39: Other diseases of upper respiratory tract J43: Emphysema J44: Other chronic obstructive pulmonary disease J45: Asthma J70: Respiratory conditions due to other external agents J84: Other interstitial pulmonary diseases J94: Other pleural conditions J98: Other respiratory disorders K00: Disorders of tooth development and eruption K03: Other diseases of hard tissues of teeth K04: Diseases of pulp and periapical tissues K05: Gingivitis and periodontal diseases K06: Other disorders of gingiva and edentulous alveolar ridge K08: Other disorders of teeth and supporting structures K11: Diseases of salivary glands K13: Other diseases of lip and oral mucosa K14: Diseases of tongue K20: Esophagitis K21: Gastro-esophageal reflux disease K22: Other diseases of esophagus K31: Other diseases of stomach and duodenum K38: Other diseases of appendix K50: Crohn's disease [regional enteritis] K55: Vascular disorders of intestine K57: Diverticular disease of intestine K58: Irritable bowel syndrome K59: Other functional intestinal disorders K62: Other diseases of anus and rectum K63: Other diseases of intestine K66: Other disorders of peritoneum K68: Disorders of retroperitoneum K73: Chronic hepatitis, not elsewhere classified K74: Fibrosis and cirrhosis of liver K75: Other inflammatory liver diseases K76: Other diseases of liver K82: Other diseases of gallbladder K83: Other diseases of biliary tract K86: Other diseases of pancreas K90: Intestinal malabsorption K92: Other diseases of digestive system L11: Other acantholytic disorders L13: Other bullous disorders L40: Psoriasis L44: Other papulosquamous disorders L51: Erythema multiforme L53: Other erythematous conditions L58: Radiodermatitis L59: Oth disorders of skin, subcu related to radiation L81: Other disorders of pigmentation L90: Atrophic disorders of skin L91: Hypertrophic disorders of skin L92: Granulomatous disorders of skin and subcutaneous tissue L93: Lupus erythematosus L94: Other localized connective tissue disorders L95: Vasculitis limited to skin, not elsewhere classified L98: Oth disorders of skin, subcu, not elsewhere classified M00: Pyogenic arthritis M05: Rheumatoid arthritis with rheumatoid factor M06: Other rheumatoid arthritis M07: Enteropathic arthropathies M08: Juvenile arthritis M10: Gout M11: Other crystal arthropathies M13: Other arthritis M15: Polyosteoarthritis M16: Osteoarthritis of hip M17: Osteoarthritis of knee M18: Osteoarthritis of first carpometacarpal joint M19: Other and unspecified osteoarthritis M25: Other joint disorder, not elsewhere classified M27: Other diseases of jaws M30: Polyarteritis nodosa and related conditions M31: Other necrotizing vasculopathies M32: Systemic lupus erythematosus (SLE) M33: Dermatopolymyositis M34: Systemic sclerosis [scleroderma] M35: Other systemic involvement of connective tissue M40: Kyphosis and lordosis M41: Scoliosis M42: Spinal osteochondrosis M43: Other deforming dorsopathies M45: Ankylosing spondylitis M46: Other inflammatory spondylopathies M47: Spondylosis M48: Other spondylopathies M50: Cervical disc disorders M51: Thoracic, thoracolum, and lumbosacral intvrt disc disorders M53: Other and unspecified dorsopathies, not elsewhere classified M62: Other disorders of muscle M67: Other disorders of synovium and tendon M76: Enthesopathies, lower limb, excluding foot M77: Other enthesopathies M79: Oth and unsp soft tissue disorders, not elsewhere classified M81: Osteoporosis without current pathological fracture M84: Disorder of continuity of bone M85: Other disorders of bone density and structure M88: Osteitis deformans [Paget's disease of bone] M89: Other disorders of bone M91: Juvenile osteochondrosis of hip and pelvis M92: Other juvenile osteochondrosis M93: Other osteochondropathies M94: Other disorders of cartilage M95: Oth acquired deformities of ms sys and connective tissue M99: Biomechanical lesions, not elsewhere classified N04: Nephrotic syndrome N07: Hereditary nephropathy, not elsewhere classified N11: Chronic tubulo-interstitial nephritis N18: Chronic kidney disease (CKD) N28: Oth disorders of kidney and ureter, not elsewhere classified N31: Neuromuscular dysfunction of bladder, NEC N32: Other disorders of bladder N36: Other disorders of urethra N39: Other disorders of urinary system N41: Inflammatory diseases of prostate N42: Other and unspecified disorders of prostate N44: Noninflammatory disorders of testis N46: Male infertility N47: Disorders of prepuce N48: Other disorders of penis N49: Inflammatory disorders of male genital organs, NEC N50: Other and unspecified disorders of male genital organs N52: Male erectile dysfunction N53: Other male sexual dysfunction N64: Other disorders of breast N71: Inflammatory disease of uterus, except cervix N76: Other inflammation of vagina and vulva N80: Endometriosis N97: Female infertility N98: Complications associated with artificial fertilization O15: Eclampsia O43: Placental disorders P05: Disord of NB related to slow fetal growth and fetal malnut P07: Disord of NB related to short gest and low birth weight, NEC P08: Disord of newborn related to long gest and high birth weight P28: Oth respiratory conditions origin in the perinatal period P29: Cardiovascular disorders originating in the perinatal period P55: Hemolytic disease of newborn P57: Kernicterus P59: Neonatal jaundice from other and unspecified causes P61: Other perinatal hematological disorders P78: Other perinatal digestive system disorders P83: Other conditions of integument specific to newborn P91: Other disturbances of cerebral status of newborn Q04: Other congenital malformations of brain Q05: Spina bifida Q06: Other congenital malformations of spinal cord Q07: Other congenital malformations of nervous system Q15: Other congenital malformations of eye Q17: Other congenital malformations of ear Q18: Other congenital malformations of face and neck Q24: Other congenital malformations of heart Q25: Congenital malformations of great arteries Q26: Congenital malformations of great veins Q28: Other congenital malformations of circulatory system Q34: Other congenital malformations of respiratory system Q38: Other congenital malformations of tongue, mouth and pharynx Q39: Congenital malformations of esophagus Q45: Other congenital malformations of digestive system Q64: Other congenital malformations of urinary system Q68: Other congenital musculoskeletal deformities Q82: Other congenital malformations of skin Q83: Congenital malformations of breast Q84: Other congenital malformations of integument Q89: Other congenital malformations, not elsewhere classified Q90: Down syndrome Q91: Trisomy 18 and Trisomy 13 Q92: Oth trisomies and partial trisomies of the autosomes, NEC Q93: Monosomies and deletions from the autosomes, NEC Q95: Balanced rearrangements and structural markers, NEC Q96: Turner's syndrome B20:Human immunodeficiency virus [HIV] disease Other, Not Listed (please list in box below) Z34: Normal Pregnancy G20: Parkinson's disease Z006: Healthy Subjects No disease or diagnosis being studied
Enter Other Disease
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Anticipated duration of treatment
Please provide in months, if possible.
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For OnCore primary completion date
Physician Name
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Medical License Number (if known )
Department
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CTR-BarbaraDavis CTR-Hemophilia-Thrombosis CTR-PerinatalResearch CTR- SickleCellTx-Research CTR-SurgicalInnovation CTR-SurgicalTx LungInfection CTR-TraumaResearch Cancer Center - Other Cancer Clinical Trial Office DHHA-EMERGENCY MED DHHA-MEDICINE DHHA-NURSING DHHA-OB/GYN DHHA-ORTHOPEDICS DHHA-PEDIATRICS DHHA-PHARMACY DHHA-RADIOLOGY DHHA-SURGERY SOM-Anesthesiology SOM-Dermatology SOM-EmergencyMedicine SOM-FamilyMedicine SOM-Immunology SOM-Medicine SOM-Neurology SOM-Neurosurgery SOM-ObstetricsGynecology SOM-Ophthalmology SOM-Orthopedics SOM-Otolaryngology SOM-Pediatrics SOM-RadiationOnc SOM-Radiology SOM-Surgery UCH - Northern Colorado - Cardiology UCH - Northern Colorado - Trauma UCH - Northern Colorado - Oncology UCH - Northern Colorado - Orthopaedics UCH - Northern Colorado - Infectious Disease UCH - Northern Colorado - Dermatology UCH - Northern Colorado - Neurosciences UCH - Colorado Springs - Cardiology UCH - Colorado Springs Emergency Department UCH - Colorado Springs - Trauma UCH - Colorado Springs - Oncology UCH - Colorado Springs - Orthopaedics UCH - Colorado Springs - Infectious Disease UCH - Colorado Springs - Pharmacy UCH - Colorado Springs - Pulmonary UCH - Colorado Springs - Neurosciences Other
Division/Section/Research Group
* must provide value
Anesthesiology Barbara Davis Center DHHA-EMERG MED-EMERGENCY MED DHHA-MEDICINE-CARDIOLOGY DHHA-MEDICINE-DERMATOLOGY DHHA-MEDICINE-ENDOCRINOLOGY DHHA-MEDICINE-GI DHHA-MEDICINE-INFECTIOUS DIS DHHA-MEDICINE-INTERNAL MED DHHA-MEDICINE-NEPHROLOGY DHHA-MEDICINE-NEUROLOGY DHHA-MEDICINE-ONCOLOGY DHHA-MEDICINE-PULMONARY DHHA-MEDICINE-RESPIRATORY DHHA-MEDICINE-RHEUMATOLOGY DHHA-OB/GYN-OB/GYN DHHA-ORTHO-GENERAL DHHA-PEDIATRICS-PEDIATRICS DHHA-SURGERY-OTOLARYNGOLOGY DHHA-SURGERY-GENERAL SURGERY DHHA-SURGERY-NEUROSURGERY DHHA-SURGERY-OPHTHALMOLOGY Emergency Medicine Med-Allergy-ClinImmunol Med-Cardiology Med-Dermatology Med-EndocrineMetabDiabetes Med-EndocrineMetabDiabetes-CUDECT Med-Gastroenterology Med-GenInternalMed Med-Geriatrics Med-Hematology Med-InfectDisease Med-Medical Oncology Med-PulmonSci-CritCare Med-RenalMed-Hypertension Med-Rheumatology Neuro-BehavNeurology Neuro-Epilepsy Neuro-GenNeurology Neuro-MovementDisorders Neuro-NeuroOphthalmology Neuro-Neurohospital-Vascular Neuro-Neuroimmuno-MS Neuro-Neuromuscular Neurosurgery OBGYN-Family Planning OBGYN-General Obstetrics and Gynecology OBGYN-Maternal Fetal Medicine OBGYN-OB Other (TBD) OBGYN-Reproductive Endocrinology OBGYN-Reproductive Sciences OBGYN-Urogynecology and Reconstructive Pelvic Surgery Oncology Ophthalmology Ortho-Denver Health Ortho-Foot and Ankle Ortho-Hand Ortho-Hip and Joint Ortho-Pediatrics Ortho-Shoulder and Elbow Ortho-Spine Ortho-Sports Medicine Ortho-Trauma Oto-Aerodigestive Oto-Airway Oto-Audiology/Otology Oto-General ENT Oto-Head and Neck Oncology Oto-Laryngology Oto-Pediatrics Peds-AdolescentMed Peds-Allergy & Immunology Peds-Cardiology Peds-CCBD Peds-ChildAbuse & Neglect (Kempe Center) Peds-CriticalCare Peds-Developmental Pediatrics Peds-Developmental Biology Peds-Epidemiology Peds-Emergency Peds-Endocrinology Peds-GastroHepatolNutrition Peds-Genetics-Metabolism Peds-Hemotology Peds-InfectiousDisease Peds-Neonatology Peds-Nephrology Peds-Neurology Peds-Pulmonary Peds-Rheumatology PhysMedicine-Rehab Rad-AbdomImaging Rad-BreastImaging Rad-Interventional Rad-Musculoskeletal Rad-Neuroradiology Rad-NuclearMedicine Rad-RadiologicalSci Rad-ThoracicImaging Surg-BurnSurg Surg-CardiothoracicSurg Surg-GITumor-EndocrineSurg Surg-PedsSurg Surg-Plastic-ReconstrSurg Surg-Podiatry Surg-Transplant Surg-Urology Surg-VascularSurg UCH - NC - Cardiology UCH - NC - Trauma UCH - NC - Oncology UCH - NC - Orthopaedics UCH - NC - Infectious Disease UCH - NC - Dermatology UCH - NC - Pharmacy UCH - NC - Neurosciences UCH - CS - Cardiology UCH - CS - Trauma UCH - CS - Oncology UCH - CS - Orthopaedics UCH - CS - Infectious Disease UCH - CS - Pulmonary UCH - CS - Neurosciences Other
If Other, please provide department and division:
* must provide value
Oncology Management Group
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CC- Children's Hospital CC- Colorado Springs CC- CTRC CC- Dermatology CC- Endocrinology CC- Gastroenterology CC- Genetics CC- GYN CC- Head & Neck SPORE CC- Heme - BMT CC- Infectious Disease CC- Lung SPORE CC- Neuro Oncology CC- Northern Colorado CC- OCRS Team CC- ORIEN CC- Other CC- Otolaryngology CC- Outreach CC- Pathology/ Tissue Bank CC- Pharmacy CC- Prevention and Control CC- Pulmonary CC- Radiation Oncology CC- Radiology CC- Sarcoma CC- Surgical Oncology CC- Survivorship CC- Urology Oncology CC- Veterans Affairs CC- Young Women's Breast Cancer CCTO - RAC/ Finance CCTO- Brain CCTO- Breast CCTO- Endocrine CCTO- GI CCTO- GU CCTO- GYN CCTO- Head & Neck CCTO- Lung CCTO- Melanoma CCTO- Phase I CCTO- Radiation Therapy CCTO- Sarcoma CCTO- Transdisease CU- Boulder Med-Hem-BloodMarrowTransplant Med-MedicalOnc
Email address of treating physician
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Please enter an institutional email address (i.e. @UCDenver.edu)
Secondary contact email (if any )
E.g person providing regulatory support
Which pharmacy will manage the product?
* must provide value
UCH AIP IDS Pharmacy UCH-Investigational Oncology RX Children's Colorado Investigational Drug Pharmacy Rocky Mountain Regional VA Medical Center Investigational Pharmacy Other
CHCO requires an Epic Use Plan and Protocol Request Form be submitted in order to build the study in Epic. Complete the following as soon as possible to avoid treatment delays:
Sign into https://casworkrequest.childrenscolorado.org/ with your CHCO credentials to complete the CAS Work Request. Download and complete the CHCO Epic Research Protocol Request Form. Submit the completed CHCO Epic Research Protocol Request Form along with your work request. Enter the pharmacy name and address for product shipment:
* must provide value
Where will the patient be treated?
* must provide value
UCHealth Metro Denver: University of Colorado Hospital (UCH) UCHealth Stapleton Medical Center UCHealth Metro Denver: Boulder Health Center UCHealth Metro Denver: Cherry Creek Medical Center UCHealth Metro Denver: Lone Tree Medical Center UCHealth Metro Denver: UCHealth Internal Medicine Clinic - Lowry UCHealth Metro Denver: Steadman Hawkins Clinic-Denver UCHealth Metro Denver: Broomfield Hospital UCHealth Northern Colorado: Greeley Medical Center UCHealth Northern Colorado: Harmony Campus UCHealth Northern Colorado: Longs Peak Hospital UCHealth Northern Colorado: Medical Center of the Rockies UCHealth Northern Colorado: Poudre Valley Hospital UCHealth Colorado Springs: Memorial Hospital, North UCHealth Colorado Springs: Memorial Hospital, Central UCHealth Colorado Springs: Pikes Peak Regional Hospital UCHealth Colorado Springs: Grand View Hospital Children's Hospital Colorado Denver Health Veteran's Administration Hospital Other Clinics/Centers managed by UCD: Barbara Davis Center Other Clinics/Centers managed by UCD: Hemophilia Clinic at UPI Other Clinics/Centers managed by UCD: Renal Clinic at UPI Other Clinics/Centers managed by UCD: Another Clinic or Center
OnCore Institution
Is there a Contract or Agreement that requires review (including those meant to be signed by the physician )?
Yes
No
Manufacturer contact for contract/agreement questions (name/email )
* must provide value
Contract or Agreement
* must provide value
Contract or Agreement, additional documents (optional )
Contract or Agreement, additional documents (optional )
Form FDA 3926 (signed )
* must provide value
Request Letter to FDA or Manufacturer (must include treatment plan, monitoring plan, patient information/diagnosis, and why an S-IDE is justified. Contact clinicalresearchsupportcenter@ucdenver.edu for a template )
* must provide value
Treatment Consent Form (unsigned )
* must provide value
Independent Physician Concurrence Letter
* must provide value
Investigator's Brochure/Device Information (or sufficient product safety/efficacy information if no IB exists )
* must provide value
Do you have a Letter of Authorization (LOA) or a Letter of Cross Reference (LOCR) from the manufacturer?
Yes
No (e.g. approved overseas only or approved for veterinary use)
Please upload the manufacturer's Letter of Authorization (LOA or LoCR)
Confirmation of cost of drug to patient if not included in LOA (an email is acceptable )
OPTIONAL: Treating Physician's Medical License (
can be looked up on DoRA )
COMIRB Chair Concurrence or approval letter, if available
Pharmacy Manual (optional )
Treatment or Surgery Plan (optional )
Clinical Trial Protocol (optional )
Additional documentation (optional )
Additional documentation (optional )
Submit
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