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Mountain States Research Department wishes all of you

Happy Thanksgiving !

We truly appreciate the opportunity to work with our

great staff and serve our local community

Mountain States Health Alliance Research Department

Message from MSHA Research Department

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The Kudos Wall 2

Training &

Documentation

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Metrics 3

IRB /MSHA Approved Studies

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Inside of this

issue:

Research Times Research Times

Gratitude unlocks the fullness of life. It turns what we have into enough, and more. It turns de-

nial into acceptance, chaos to order, confusion to clarity. It can turn a meal into a feast, a house

into a home, a stranger into a friend. Melody Beattie, Author

Issue 12, November 2016

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CLASS A, OPEN FOR RECRUITMENT STUDIES

SUNSHINE : A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group

Study to Investigate the Safety and Efficacy of study drug Oral Suspension or Tablets,

and Vancomycin Oral Liquid or Capsules in Pediatric Subjects with Clostridium dif-

ficile-associated diarrhea.

MSMG Neurologist, Dr. Shams, in collaboration with

MSHA Research department staff and Dr. Burns trau-

ma team, successfully enrolled 38 participants in the

record time of 3 months!

NON-BLINDED DATA COLLECTION STUDY OF CONCUS-

SION USING THE BRAINPULSE™ sponsored by Jan Medi-

cal, Inc. is open for recruitment. To learn more about

eligibility and/or refer patients, contact research de-

partment at 423-431-5647or adkinsce2@msha.com.

Dr. Shah, ETSU

pediatrician, and MSHA

research department team

have been recognized in the

Astellas & INC/Sponsor

newsletter for great

performance.

In Radiation Oncology area, 2 research participants successfully completed an Active Treatment Phase on Galera study :A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi- Center, Trial of the Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients Receiving Post-Operative or Definitive Therapy with Single-Agent Cisplatin plus IMRT for Locally Advanced, Non-Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx. Research department applauds Dr. Colvett, Dr. Floyd, and supportive staff from med onco and rad onco areas. Great Teamwork!

Issue 12, November 2016

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Training and Documentation: Some Keys to Risk-Based Monitoring

During MSHA Research Orientation Training, our team always emphasizes the im-

portance of completing required trainings, the review of research related SOP’s and de-

velopment of the organizational skills for proper management of documentation. The

landscape of the research world is constantly changing; therefore, we need to be more

adaptive and stay in-tune. One of the latest changes is related to risk-based monitoring.

As Karen Olson outlined in 2013, “the industry cannot afford to continue with the previ-

ous monitoring approach where sponsors did 100% source document verification. That

method is costly, not very effective, and tends to allow the research to get stuck in the mi-

nutia. A risk-based approach will focus resources on the critical measures that will im-

pact the research and the research subjects. Understanding what the vital measures are

and developing systems at the sites to focus on them will be part of the plan for prepar-

ing your site for success in risk-based monitoring. Each trial will have its own critical

measures. Therefore, protocol training at the site level becomes even more important.

All of the site personnel that are working on a given trial need to understand the process-

es and data points that are crucial to the study. Documentation of the training that oc-

curs will help the sponsor (and the site) know who is trained and prepared to conduct the

study.

As the trial is underway, retraining will likely become necessary. All sites should have

plans and standards for the general training that is required of sites: good clinical prac-

tice, good documentation principles, and industry standards. Beyond that, each study

will have its own set of critical success factors. Understanding those from the beginning

of the study, documenting successful training, and planning for retraining as needed will

be one way to prepare for the future of risk-based monitoring.”

Note: If you are interested in discovering more learning opportunities, please contact

Christy Adkins at 423-431-5647 or Nonna Stepanov at 423-431-5654.

Metrics to share

Issue 12, November 2016

https://api.hubapi.com/email/v1/click?v=1&e=CNCZDRCjqtkDGrwCaHR0cDovL2ZvcnRlcmVzZWFyY2guY29tL25ld3MvdHJhaW5pbmctYW5kLWRvY3VtZW50YXRpb24tc29tZS1rZXlzLXRvLXJpc2stYmFzZWQtbW9uaXRvcmluZy8_dXRtX2NhbXBhaWduPWFsbGVncm8tbm90ZXMtdXMmdXRtX3NvdXJjZT1odWJzcG90X2VtYWlsX21

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Issue 12,

New Approvals

PI: Paul, Timir, M.D., Coronary Artery Disease Management Outcomes in Patients with Baseline Thrombocyto-

penia

PI: Moorman, Jonathan, M.D., Allergic and Immunologic Diseases Repository

PI: Cook, Cathleen, M.D., RMS13: Risk adapted Focal Proton Beam Radiation and/or Surgery in Participants

with Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

(Initial and Minor Modification)

PI: Chakraborty, Kanishka M.D., Influence of therapy to 'Time to Progression' in Microsatellite Instability-

High (MSI-H) and Microsatellite Stable Tumors (MSS) - Stage III & Stage IV Colon Cancer in RCC

PI: Shams, Tanzid, M.D., Non-Blinded Data Collection Study of Concussion using the BrainPulse

PI: Wood, David M.D., Development of a research database for studies of infants exposed to drugs that can

cause neonatal abstinence syndrome (NAS)

PI: Mason, Brian M.D., 03-0101 Stryker Wingspan Stent System with Gateway PTA Balloon Catheter

PI: Wohlford, George F IV PharmD., Impact of a 72 hour automatic stop and pharmacist-led review on the

empiric use of vancomycin

Continuing Reviews, Modifications and Study Closures

PI: Popescu, Marcela M.D., SJYCO7 (continuing review)

PI: Rush, Daniel M.D., Retrospective evaluation of peripheral vascular disease (Continuing Review)

PI: Moore, Norman M.D., Effect of Passive Immunization on the Progression of Mild Alzheimer ’s disease:

Solanezumab (LY2062430) vs. Placebo (Continuing Review)

PI: Paul, Timir, M.D., BNP as a predictor of Successful cardioversion in persistent atrial fibrillation without evi-

dence of heart failure (Continuing Review)

PI: Lavine, Steven, M.D., Variables Heart Failure Readmission and Mortality in a Community Based Cohort

(Continuing Review)

PI: Bishop, Thomas PsyD from Tudiver, Fred M.D., To Identify the Role of Patients' Personal-Familial-

Cultural Experiences in Cancer Decision Making and to Develop an Effective Cancer Care Communication

Training Module aka: Instructional Modules to Improve Cancer Communication (Continuing Review, 2 Minor

Modifications)

PI: McKenzie, Tamra M.D., "Radioactive Seed Localization vs. Wire-Guided Lumpectomy- Which Has a Better

Outcome?" (Continuing Review)

PI: Klopfenstein, Kathryn M.D., HLHR13: Adcetris (Brentuximab Vedotin) Substituting Vincristine in the

OEPA/COPDAC Regimen [Treatment Group 3 (TG3) of Euro-Net C1] with involved Node Radiation therapy

for High Risk Pediatric Hodgkin Lymphoma (HL) IND# 118603 (Continuing Review)

Clinical trials that received IRB & MSHA approval (April 22-October 31, 2016)

Issue 12, November 2016

5

Continued

PI: Moore, Norman MD., 221AD301, A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-controlled,

Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzhei-

mer's Disease (ENGAGE)

PI: Mamudu, Hadii M.D., Cardiovascular Health Management (Continuing Review, Minor Modifcation)

PI: Bossaer, John PharmD., Oral Oncolytic Drug Interactions in a Community Cancer Center (Continuing re-

view)

PI: Brahmbhatt, Vipul, M.D., Quadripolar pacing post approval study (Acknowledgements, Modification)

PI: Miller, Merry M.D., Placental changes in expressed mRNA and epigenetic factors in depressed mothers with

and without antidepressant and/or psychotropic drug administration and in normal controls (Study Closure)

PI: Colvett, Kyle M.D., A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Trial of the

Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients Receiv-

ing Post-Operative or Definitive Therapy with Single-Agent Cisplatin plus IMRT for Locally Advanced, Non-

Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx (3 Minor Modification, IRB Acknowledg-

ment, Continuing Review)

PI: Klopfenstein, Kathryn M.D., HODD: Risk Adapted Therapy for Pediatric Hodgkin's Disease (Continuing

review)

PI: Klopfenstein, Kathryn M.D., HOD05 (Continuing Review)

PI: Massey, Samuel, M.D., HUD the Neuroform Microdelivery Stent System A Humanitarian Use Device

(Minor Modification)

PI: Elgazzar, Mohamed, M.D., MicroRNAs and myeloid cell development during sepsis (Continuing Review,

Minor Modification, 2 Acknowledgement)

PI: McKenzie, Tamra, M.D., "Radioactive Seed Localization vs. Wire-Guided Lumpectomy- Which Has a Better

Outcome?" (2 Minor Modification)

PI: Brahmbhatt, Vipul, MD., Safety and Cost Effectiveness of Same Day Discharge after Implantable Cardio-

verter-Defibrillator Implant vs. Next Day Discharge (Study Closure)

PI: Massey, Samuel, M.D., HUD Enterprise Vascular Reconstruction Device & Delivery System (Minor Modifi-

cation)

PI: Klopfenstein, Kathryn, M.D., HLHR13: Adcetris (Brentuximab Vedotin) Substituting Vincristine in the

OEPA/COPDAC Regimen [Treatment Group 3 (TG3) of Euro-Net C1] with involved Node Radiation therapy

for High Risk Pediatric Hodgkin Lymphoma (HL) IND# 118603 (Non-Minor Modification)

PI: Shah, Darshan M.D., A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Inves-

tigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liq-

uid or Capsules Taken q6h, for 10 Days in Pediatric Subjects with Clostridium difficile-associated Diarrhea

(Acknowledgment)

PI: Cook, Cathleen, M.D., SJMB12: A clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Me-

dulloblastoma (Continuing Review, Non-Minor Modification)

PI: Klopfenstein, Kathryn, M.D., CSqHPV: Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Phase II Open-Label Vaccine Trial (Continuing review, 2 Minor Modification)

Issue 12, November 2016

6

Continued

PI: Klopfenstein, Kathryn MD., Total Therapy Study XVI for Newly Diagnosed Pts. w/Acute Lymphoblastic

Leukemia (Continuing Review)

PI: Lowe, Krista, CHOMP (Continuing Review, Minor Modification)

PI: Barklow, Thomas MD., BER-EP4 Positive Staining in Bowen's Disease, A Potential Pitfall when Differenti-

ating Bowen's Disease from Extramammary Paget's disease (Continuing Review)

PI: Popescu, Marcela M.D., TBANK: Protocol for Collecting, Banking, and Distributing Human Tissue Sam-

ples: TBANK St. Jude Children's Research Hospital Tissue Resources Core Facility (Continuing Review)

PI: Hamati, Fawwaz, M.D., HUD Graftmaster Coronary Stent Graft (Continuing Review)

PI: Hamati, Fawwaz, M.D., Analyze ST-ST Monitoring to detect ACS events in ICD patients study (2 Acknowl-

edgement)

PI: Hiremagalur, Shobha M.D., St. Jude Medical Cardiac Lead Assessment Study (Continuing Review, Non-Minor Modification, 5 Acknowledgment, Minor modification) PI: Klopfenstein, Kathryn MD., HOD08: Reduced duration Stanford V Chemotherapy with Low-Dose Tailored

-Field Radiation Therapy for Favorable Risk Pediatric Hodgkin Lymphoma (Continuing Review)

PI: Wiles, David M.D., A Prospective, Randomized, Controlled, Multi-Center Pivotal Clinical Trial of the Artifi-

cial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disease (Continuing Review, 2 Acknowledgement)

PI: Morin, David, M.D., A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical

Trial to Study the efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Im-

pairment Due to Alzheimer's disease (Prodromal AD) (Continuing Review)

PI: Aboaziza, Ahmad, M.D., Comparing length of hospital stay amount Neonatal Abstinence Syndrome (NAS)

(Continuing Review)

PI: Lindquist, Desirae, PharmD, Comparison of Post-operative Bleeding in Patients undergoing Total Hip Ar-

throplasty or Total Knee Arthroplasty Receiving Enoxaparin, Rivaroxaban, or Aspirin for Thromboprophylaxis

(Continuing Review)

PI: Bailey, Beth PhD., Tennessee Intervention for Pregnancy Smoking (4 Minor Modifications, continuing re-

view)

PI: Shams, Tanzid, M.D., Non-Blinded Data Collection Study of Concussion using the BrainPulse (4 Acknowl-

edgments)

PI: Khan, Ahmed, M.D., Advance CRT Registry (6 Acknowledgments)

PI: Popescu, Marcela M.D., A Double-Blind, Randomized, Placebo-Controlled, Trial of Ethanol Lock Therapy

for Treatment and Secondary Prophylaxis of Central Line Associated Bloodstream Infection (CLABSI) in Children

and Adolescents (Study Closure)

PI: Cluck, David, PharmD., Evaluation of clinical outcomes in bloodstream infections secondary to chromoso-

mally-mediated AmpC-producing organisms (Continuing review)

PI: Moore, Norman, M.D., Hyperbaric Oxygen (HBO) Therapy for Diabetic Encephalopathy (Minor Modifica-

tion, Continuing Review)

PI: Moore, Norman, M.D., A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-

group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic study of AZD3293 In Early Alzheimer's

Disease (The AMARANTH Study)

Issue 12, November 2016

7

Jennie Augusta Brownscombe, The First Thanksgiving at Plymouth, 1914,

Pilgrim Hall Museum, Plymouth, Massachusetts

Historical reminder: Thanksgiving, originated as a harvest festival, has been celebrated nationally on and off since 1789, after a proclamation by George Washington. It has been celebrated as a federal holiday every year since 1863, when, during the American Civil War, President Abraham Lincoln proclaimed a national day of "Thanksgiving and Praise to our beneficent Father who dwelleth in the Heavens," to be celebrated on the last Thursday in November..

The event that Americans commonly call the "First Thanksgiving" was celebrated by the Pilgrims after their first harvest in the New World in 1621.This feast lasted three days, and—as accounted by attendee Edward Winslow—it was attended by 90 Native Americans and 53 Pilgrims. The New England colonists were accustomed to regularly celebrating "thanksgivings"—days of pray-er thanking God for blessings such as military victory or the end of a drought.

Issue 12, November 2016

Continued

PI: Massey, Samuel, M.D., HUD Enterprise Vascular Reconstruction Device & Delivery System (Minor modifi-

cation)

PI: Hiremagalur, Shobha MD., St. Jude Medical Cardiac Lead Assessment Study (Minor Modification)

Are you interested in research? Mountain States Research department welcomes new researchers. Come and share your ideas with us and we will help you identify potential sponsors and /or Grant opportunities. We will discuss legal, regulatory, financial, and data collection arrangements to support your study.

https://en.wikipedia.org/wiki/Jennie_Augusta_Brownscombehttps://en.wikipedia.org/wiki/Pilgrim_Hall_Museum