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Institutional Review Board (IRB)
The purpose of the Institutional Review Board or "IRB," at Riverside Regional Medical Center is to protect the rights and welfare of patients involved in research protocols. This abides by the federal regulations in the Federal Register (21CFR Part 56) on Protection of Human Subjects.
The IRB currently has 25 members and meets once a month to review new protocols, amendments to protocols, progress reports, adverse events and other educational material. The IRB is composed of physicians, hospital staff, including nurses and pharmacists, as well as community representatives. Protocols are reviewed to assure that risks and benefits are addressed, and that patients are fully aware of these risks and benefits. Charlie Frazier, M.D., is the Chairman of the IRB.
The IRB meets every third Wednesday at 7:30 a.m. If you would like to submit a protocol for review, please contact Delana Merenda, Performance Improvement Coordinator, at (757) 594-3168.
Current list of Clinical Trials
| H7T-MC-TABY(a) |
Cardiology |
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A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Mangaed.
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| ENGAGE AF-TIMI 48 |
Cardiology |
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DU176b-C-U301: Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multicenter, Multi-National Study for Evaluation of Efficacy and Safety of DU-176B versus Warfarin in Subjects with Atrial Fibrillation - Effective aNticoaGulation with factor xA next Generation in Atrial Fibrillation
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| ENGAGE AF-TIMI 48, Sub-Study C |
Cardiology |
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Phase 3, Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter, Multi-National Study for Evaluation of Efficacy and Safety of DU-176B Versus Warfarin in Subjects with Atrial Fibrillation-Effective aNitcoaGulation with factor xA next Generation in Atrial Fibrillation (ENGAGE AF-TIMI 48)
Central IRB: Copernicus
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| ALERTS Study |
Cardiology |
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AngeLmed for Early Recognition and Treatment of STEMI, #0201-0601-008 Rev C
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| H7T-US-B007 - Translate ACS Registry |
Cardiology |
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Treatment with ADP receptor iNhibitorS; Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome, Translate-ACS Registry
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| JOSTENT, HUD |
Cardiology |
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JOSTENT Graft Master Coronary Graft and Delivery System - Humanitarian Use Device
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| LY2127399 - Lupus Study |
Family Practice |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safett of Subcutaneous LY2127399 in Paitents with Systemic Lpus Erythematosus (SLE)
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| EVP 6124 - Alzheimer's Disease |
Family Practice |
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A Randomized, Double-Blind, Placebo-Controlled, Parallel, 24-Week, Adaptive Design Phase 2 Study of 3 Different Doses of an Alpha-7 Nicotinic Acebylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects with Mild to Moderate Probable Alzhemier's Disease
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| H-030-012 - C-diff Study |
Family Practice |
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Phase 2, Randomized, Placebo-Controlled, Modified Double-Blind, Dose-Ranging, Mult-center Trial for Safety and Immmunogenicity of Different Formualtions of a Clostridium Difficile Toxoid Vaccine Administered at 3 Different Schedules in Adults Aged 40-75 years of age at risk for C-diff
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| Precision |
Family Practice |
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Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naprosyn
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| GE/GERD Protocol |
Family Practice |
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Using an HER Based Intervention to Improve Quality of Care of GERD and Gastroprotection for Patients on NSAIDS: A Randomized Controlled Trial
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| CEASE |
Family Practice, Pediatrics |
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Sponsor: NCI, The Agency for Healthcare Research and Quality, The Natinal Instittute on Drug Abuse
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| Celgene - Rheumatoid Arthritis |
Geriatric - Family Practice |
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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group Study, to compare the Efficacy and Safety of 2 Doses of Apremilast in Subjects with Active Rheumatoid Arhtritis who have had an Inadequate Response to Methotrexate
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| Takeda TMX-67-203 |
Gerientology |
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A Multicenter Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of Febuxost Versus Placebo on Renal Function in Gout Subjects with Hyperuricemia and Moderate to Severe Renal Impairment.
Waiver of Jurisdiction to Schulman IRB approved by RRMC IRB March 30, 2010.
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| CENA713DUS44, Dementia Study |
Gerientology |
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A 24-Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of Rivastigmine Patch 15 cm2 vs. Rivastigmine Patch cm2 on Activities of Daily Living and Cognition in Patients with Severe Dementia of the Alzhemier's Type (ACTION)
Waiver of Jursidiction to Quorum IRB approved by RRMC IRB March 3, 2010
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| Nurse Documentation to Reduce Infections |
Infectious Disease |
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Objective: To enhance quality and safety processes at RRMC to include tools that assist in the development of appropraite information technology systems and applied technology that are an essential part of patient safety, quality and care delivery.
Full Board approval by RRMC IRB on December 1, 2010.
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| LIN-MD-01 |
Medical |
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This protocol being conducted by Dr. Fisher at Health Research of Hampton Roads. Will refer patients for colonoscopies to Riverside Peninsula Gastroenterology or Riverside Endoscopy Suite.
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| PE Screening Tools |
Medical |
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PE Screening Tools and Judicious Use of Pulmonary Angiography in the ED
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| H9B-MC-BCDJ |
Neurology |
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This is a Phase 2, Multicenter, Randomized, Double-Blind, Placeob-Controlled, Parallel Group, Dose--Ranging, Outpatient Study
Approved by IRB May 6, 2009. Waiver of Jurisdiction to Central IRB: Copernicus Group
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| Global Observation Program in Safety |
Neurology |
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This study is to collect information on serious infections, cancers, and other serious side effedts that may occur in patients with multiple sclerosis treated with TYSABRI.
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| CFTY720DUS01, Multiple Sclerosis |
Neurology |
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A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod 0.5 mg/day in Patients with Relapsing Forms of Multiple Sclerosis who are candidates for MS therapy change from Prevous Disease Modifying Therapy (EPOC)
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| Athena Pelvic Muscle Trainer |
Ob-Gyn |
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Phase IV Trial. Device to treat urinary incontinence. Effectiveness, Tolerability, and Satisfaction.
#NCTO1073878
Approval to waive to Central IRB, Sterling IRB, on May 5, 2010.
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| Improving Umbilical Cord Transection |
Ob-Gyn |
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Improving Umbilical Cord Transection by use of a new prototype device, which would doubly clamp and cut an umbilical cord with one motion.
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| Dr-103, Oral Contraceptive |
Ob-Gyn |
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A Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (Dr-103) for the Prevention of Pregnancy in Women
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| MORAb-003-004 |
Oncology |
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A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Access the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Caroplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
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| SWOG SO421 |
Oncology |
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A Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
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| SCRI BRE 145 |
Oncology |
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Sponsor: SCRI Oncology Research Consortium
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| Wyeth 3144A2-3004-WW - Breast Cancer - |
Oncology |
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A Randomized Double-Blind, Placebo-Controlled Trial of Neratinib (NKI-272) after Trastuzumab in Women with Early-Stage HER-2/NEU Overepressed/Amplified Breast Cancer - Commercial Central IRB Study
Central IRB: Schulman IRB
Sponsor: Wyeth Pharmaceuticals
Waiver of Jurisdiction to Schulman IRB on 8-5-09.
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| OGX-011-10 |
Oncology |
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A Randomized, Placebo-Controlled, Double-Blind, Phase III Study Evaluating the Clinical Benefit of Adding Custiresen to Docetaxel ReTreatment/Prednisone as an Option for Second-Line Therapy in Men with Castrate Resistant Prostate Cancer
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| SCRI MEL-19 |
Oncology |
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A Phase II Study of Everolimus in Combination with Paclitaxel and Carboplatin in Patients with Metastatic Melanoma
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| SCRI LUN 183 |
Oncology |
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A Phase II Trial of Carboplatin, Pemetrexed, and Panitumumab in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer without K-RAS Mutations
Waiver of Jurisdiction to Western IRB approved by RRMC IRB March 3, 2010.
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| SCRI BRE 126, Breast Cancer |
Oncology |
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A Phase II Trial of Panitumumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer
Waiver of Jurisdiction to Western IRB approved by RRMC IRB March 3, 2010.
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| SCRI MM23, Mutliple Myeloma |
Oncology |
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A Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First Line of Treatment of Multiple Myeloma
Waiver of Jurisdiction to Western IRB approved by RRMC IRB March 3, 2010.
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| NSABP B-38 |
Oncology |
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This study was submitted through the National Cancer Institute Central IRB. Received RRMC IRB facilitated review December 2005.
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| ECOG PACCT-1 |
Oncology |
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This study is approved through National Cancer Institute Central IRB. Received facilitated review by RRMC IRB July 2006. (IRB meeting 7-5-06)
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| SCR4 G165 |
Oncology |
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A Phase II Study of 5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in the Adjuvant Treatment of Patients with Stage II/III Rectal Cancer
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| SCRI LUN142 |
Oncology |
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Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib versus Chemotherapy Alone in Patients wit Resected Non-Small Cell Lung Cancer
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| ION 06-031 |
Oncology |
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ION 06-031, B9E-US-S379 - A Phase II Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated with Tzanes
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| ECOG E5103 |
Oncology |
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A Double-Blind Phase III Trial of Dose Dense Doxorubicin and Cyclophosphamde Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Negative Breast Cancer
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| SCRI GU 43 |
Oncology |
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A Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients with Advanced Clear Cell Renal Carcinoma
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| SCRI BRE 116 |
Oncology |
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A Phase II Trial of Nanoparticle Albumin-Bound (nab) Paclitaxel-Cyclophosphamide in Early-Stage Breast Cancer
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| Thyroid Cancer, XL184 |
Oncology |
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Thyroid Cancer - An International, Randomized, Double-Blinded Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer (Commercial Central IRB Study)
Sponsor: Exelixis, Inc.
Central IRB: Schulman Associates IRB
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| AVF4349n |
Oncology |
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Sponsor: Genentech, Inc.
Waiver approved by RRMC IRB 8-6-08
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| CA 184-045 |
Oncology |
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A Multicenter Treatment Protocol for Expanded Access Use of Ipilimumab Monotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma
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| SCRI UNKPRI 21, Carcinoma of Unknown Primary |
Oncology |
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An ope-label randomized phase II trial of belinostate (PXD101) in combination with Carboplatin and Paclitaxel comapred to Carboplastin and Paclitaxel in patients with previously untreated carcinoma of unknown primary
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| SCRI LUN 199 - Lung Cancer |
Oncology |
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A Phase II Trial of Amrubicin and Carboplatin with Pegfilgrastim in Patients with Extensive-Stage Small Cell Lung Cancer
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| SCRI LUN 201, Lung Cancer |
Oncology |
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20090321, ECF 11553 - A Randomized, Phase III Trial of Gemcitabine/Carboplastin with or without BSI-201 in Patients with Previously Untreated Stage IV Squamous Non-Small Cell Lung Cancer
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| OGX-011-11 |
Oncology |
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A Randomized Phase III Study Comparing Standard First-Line Docetaxel and Prednisone to Docetaxel and Prednisone in Combination with Custirsen in Men with Metastatic Castrate Resistant Prostate Cancer
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| GOG 0252 |
Oncology |
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A Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
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| Veeda 10-11 |
Oncology |
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14T-MC-JVBA - A Randomized, Double-Blind, Phase III Study of Docetaxel and Ramucirumab vs. Docetaxel and Placebo in the Treatment of Stage IV Non-small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy
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| Veeda 10-008 |
Oncology |
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A Phase II, Multicenter, Single-Arm Study of Eribulin Mesylate with Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (Her2) Positive Breast Cancer
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| Veeda V10-012 |
Oncology |
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A Randomized, Phase II Study of Imetelstat (GRN163L) in Combination with Paclitaxel in Patients wth Lcally Recurrent or Metastatic Breast Cancer
Waiver of Jurisdiction to Central IRB, Western IRB, by RRMC IRB on 11-3-10
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| Veeda V10-009 |
Oncology |
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A Randomized, Double-Blind, Multicenter Phase III Study of Irinoteca, Folinic Acid, and 5-Fluorouracil (FOLFIRI) plus Ramucirumab or Placebo in Patients with Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy with Bevacizumab, Oxaliplatin and a Fluoropyyrimidine
Waiver of jurisdiction to Central IRB, Western IRB, by RRMC IRB on 11-3-10
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| Veeda V10-015 |
Oncology |
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A Randomized, Open-Label, Phase III Study of Pemetrexed plus Carboplatin Followed by Maintenance Pemetrexed versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Advanced Non-small Cell Lung Cancer of Nonsquamous Histology
Waiver of Jurisdiction to Central IRB, Western IRB, by RRMC IRB on 11-3-10
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| SCRI CNS 12, Meningioma |
Oncology/Neurology |
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A Phase II Trial of the Combination of Bevacizumab and Everolimus in Patients with Refractory, Progressive Intracranial Meningioma
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| Pain Management and Heart Rate Variability |
Pain Management |
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Two Consecutive Studies for Acceptance Rates of Chronic Low Back Pain with Heart Rate Variabilty and Acceptance Rates of fibromyalgia with Heart Rate Variability.
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| ONYX HD-500 |
Radiation Therapy |
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Onyx Liquid Embolic System, Humanitarian Device Exemption
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| GII98745 |
Urology |
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A Randomized Double-Blind Parallel Group Study Comparing Casodex 50 mg. plus Placebo to Casodex 50 mg. lus dutasteride 3.5 mg. Administered for 18 months to Men with Prostate Cacner Who Have Failed First-Line Androgen Deprivation Therapy Followed by a Two-Year Extension Phase
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| Vicinium for Urothelial Carcinoma in Situ |
Urology |
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Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Patients with Non-Invasive Urothelial Carcinoma in Situ Previously with Bacille Calmette-Guerin
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