Embed Size (px)
Citation preview
Research Coordinators Quarterly Meeting
June 6, 2017
Agenda • CTMS Update—Courtney Kennedy • FDA Audits—LuAnn Larson• RepTrax – LuAnn Larson• UNeHealth Training Tools – Amy Carson• Nebraska Medicine Price Increase – Katie Penas• Applying Indirects to Chesapeake Fees – Katie Penas• Pathology Reference Information – Salma Elhag• One Chart Update – Calli Sibilia• Compliance- Grace Videtich & Kristi Kiviniemi• IRB Updates-Krista Bayley
Clinical Trial Management SystemContract fully executed and agreed on by all parties!
Special thanks to all involved to this point and more FUN to come!!!
FDA AuditsLuAnn Larson
FDA Audit GuidanceCovers• Notification• Who you should inform• Preparing for the inspector• Where to locate the inspector• Meeting the inspector• The process and what to expect• Records to gather• Communications• Who to have in your “war room”• Closing visit• Responding to a Form 483
Can be found on nhssecure drive, folder #5 (Resources)
Contributors
• Natalie Kamtz – Cardiothoracic Surgery• Sarah Gloden-Carlson – Chief Compliance Officer• Julie Ehlers – Hematology Oncology• Perelman School of Medicine Office of Research presentation, “How to
Survive an FDA Inspection”, March 27, 2014• Forte Research Systems Webinar, “What You Need to Know to Prepare for
and FDA Audit” • US Department of Health and Human Services FDA “Information Sheet
Guidance for IRBs, Clinical Investigators and Sponsors – FDA Inspections of Clinical Investigators”, June 2010
RepTrax UpdateLuAnn Larson
Contact Information for QuestionsChanel HubbyPurchasing AssociatePhone: 552-3107
Mary DurkanPurchasing AssociatePhone: 552-3107
RepTrax Help1-817-732-3873 Extension #3 or #7
Reminder: Study monitors should apply for the base membership
UNeHealth Training ToolsAmy Carson, MPAUNeHealth Manager
Agreement Types Negotiated by UNeHealth• CDA’s for Industry Sponsor Clinical Trials
• Industry Sponsor Clinical Trials, Phase I-IV
• Master Industry Sponsored Clinical Trial Agreements
• Compassionate Use Agreements
• Emergency Use Agreements
• PI Initiated Trials
• Device Studies
UNeHealth GuidebookUNeHealth Webpage
Key Takeaways• Work with PI to determine feasibility of Study
• Send required documents to UNeHealth
• Negotiate contract budget with Sponsor (or use CRC)
• Communicate with Department Administrator
Contact Information• Amy Carson - Manager
• Amanda Leingang – Contracts [email protected]
• Augustine Osuala – Contracts [email protected]
Nebraska Medicine Price IncreaseKatie Penas, MHA, CNMT, RT(N)Clinical Trials Analyst
Nebraska Medicine Price Increase• Effective Date: 4/15/17
• Price increases were applied to all hospital codes
• Most physician charge codes were unchanged
• Overall price increase was 5%
Additional Review Recommended
Provider-based Clinics Update (HODs)• Effective Date: 6/13/17
• All Omaha metro clinics will become provider-based clinics
• A hospital/facility charge as well as a physician charge will be generated for clinic services
• Primary reason for the change – to have consistency in registration, care and billing across all Nebraska Medicine clinics
Indirect Fees on ChesapeakeKatie Penas, MHA, CNMT, RT(N)Clinical Trials Analyst
UNeHealth Studies Utilizing Chesapeake• Effective July 1, 2017 on UNeHealth studies
where Chesapeake is the IRB of record and the sponsor requires UNMC to invoice on behalf of Chesapeake, Sponsored Programs Accounting will now treat Chesapeake as a vendor.
• Indirects/Overhead will be collected on the amount paid to Chesapeake.
• GL Code (Medical/Clinical) = 526400
Pathology Reference InformationSalma ElhagTissue Services Technologist
Pathology and research Translational research in pathology aims to bring the discoveries from the
lab bench to the bedside. Active research spans all aspects of scientific methods and theories about
disease which may include one or more of the following:
a) Basic pathology and molecular mechanismsb) Pathologic characterization and manifestationc) Application of new laboratory techniquesd) Diagnostic or prognostic biomarkerse) Clinical management and patient outcome
Type of services offered by Pathology dept.The Pathology department offers several types of services that make researchers nock our doors for help with their trending researches.There are two categories of research studies:
• Clinical trials• Translational research studies
Type of services:• Case review• Fresh Tissue• Frozen tissue (at time of surgery or archived)• Unstained slide • H&E slide• In house special stains and other type of special handling• DNA/ RNA preparation, FISH, cytogenetic analysis..etc
Understanding how to approach pathology services
https://www.unmc.edu/pathology/research/resources/researchtissue.html
Requesting Pathology Approval1) Email Salma Elhag at [email protected]
a) Subject line: “Preliminary Approval for a pre IRB-approved protocol with tissue requirements: (Sponsor, Sponsor Trial ID, PI)”
b) Attach protocol and lab manual (if available). Please specify section and page numbers pertinent to tissue requirements.
2) Upon approval, pathology will:1) Track approval in pathology database2) Forward email containing pathology approval to the individual
submitting the trial for approval
Pathology will record of clinical trial approval workflow with IRB # for future reference.
Regulatory specialist (CRC)
Dr. Talmon ( Slid Tumor)Or Dr. Greiner ( Heme)
Request for pathology approval
Requesting Tissue/Slides1. Research staff will complete the “Pathology Request for Research Studies”
form and email it to [email protected]. 1. The request form can be found on the UNMC website:2. Please ensure that the IRB # and Cost Center/Grant
account are accurate, and billing address details provided in case of outside requests
3. Preferable if the requestors fill out the form themselves
Tissue procurement resource center
Request for Tissue/ slides with added services
Assigned Pathologist
TSF(histology services and
special staining
Tissue services/slide
room
Dr. Ly ( only for fresh tissue in time of surgery)
Research Tissue Services Resource Sheet
VCR Website: https://unmc.edu/cctr/resources/pathology.htmlPathology Website: https://www.unmc.edu/pathology/research/resources/researchtissue.html
Contact InformationSalma ElhagOffice:402-559-4123Pager: [email protected]
One Chart ResearchCalli SibiliaClinical Informatics Lead-Research
You need your study built in One Chart if…• You will be consenting patients
• Your patient will have encounters where there are billable charges. This includes:
• Orders for procedures/medications• Physical exams
You DO NOT need your study built in One Chart if you are just collecting data and there are no billable charges.
Research Collect OrdersThe following orders should be used when your study requires specimen collection that will be sent to a core lab (determined by the study) to be resulted:
• Collection for blood- research only (lab)• Collection for non blood- research only (lab)
Instructions to the lab staff MUST be included in the order comments and at a minimum should indicate:
• What is being collected• Ex. 1 red top, 1 purple top• Ex. Collect all tubes contained within kit
• If any processing is needed• If the specimen(s) will need to be stored and where• Who should be contacted to pick the specimen(s) up
Coordination for lab specifics should be made with Lab Manager, Jo [email protected]
Research SmartSets/OrderSetsSmartSetAn ordering tool for use in an OUTPATIENT setting which can contain the following:• Study orders (ex. Collection for blood- research
only, CBC, Brain MRI, medications)• Research Diagnosis (Z00.6)• Level of Service charges (ex. Physical exam)
OrderSetAn ordering tool for use in an INPATIENT setting. OrderSets can only contain study related procedural or medication orders.
Research SmartSets/OrderSetsPer policy IM41 you need a SmartSet/OrderSet for your study if your study includes:• Procedural orders (this includes labs)• Medications• Investigational medications
Request One Chart Study SmartSet/OrderSet by emailing Calli Sibilia ([email protected])
• This should be requested AT LEAST 1 month in advance of need
• Complete SmartSet/OrderSet request form and email back to Calli with a copy of your study matrix
One Chart Study Build Diagram
Consult Matrix
Request SmartSet/OrderSet and any
investigational meds
One Chart
Ordering tools built
One Chart Research deactivates
Study
Study ActivatedStudy
Activated
• SmartSets/OrderSets should be requested at least 1 month in advance of when they will be needed
• WBS (or other account number when applicable) is REQUIRED in order for study to be activated in One Chart
• Alert One Chart team when your study is closed in order for it to be deactivated
One Chart 2017 Version Upgrade
Coming Soon! September
2017
• Notifications for deceased patients• More targeted In Basket notifications• Results routing to study staff
ContactCallista [email protected]‐3553
Compliance Grace Videtich & Kristy Kiviniemi
Compliance UpdatesEducational Series
Compliance will be partnering with Clinic Research Operations, UNCM Compliance and the IRB to provide the following education:
What to expect and how to prepare for audits from external sources (FDA, Sponsor, State)
Clinical Research Policy Overview Each month a policy and procedure will be introduced for
suggested reading from Compliance. Coordinators will have an opportunity to ask questions and engage in discussion about each policy.
Compliance CornerHow can we help You?
Grace L. Videtich, BSCompliance Sr. [email protected]
Kristy Kiviniemi, BS, RNInternal Audit & Compliance Monitoring, [email protected]
IRB Update –ClinicalTrials.GovKrista BayleyGail Paulsen
Registration Criteria‒ Required for trials that meet definition of “applicable clinical
trial” (ACT) and was initiated after September 27, 2007. – interventional studies of FDA-regulated drugs, biological
products, or devices that meet one of the following conditions:
• Trials has one or more sites in United States• The trial is conducted under an FDA investigational new drug
application or investigational device exemption• The trial involves a drug, biologic, or device that is
manufactured in the United States or its territories and is exported for research
– All federally funded clinical trials, whether or not they all under FDAAA Req.
– International Committee of Medical Journal Editors and other journals require registration of clinical trials so please check with journals you plan to publish with.
Final Rule Definition of ACT - https://www.federalregister.gov/d/2016-22129/p-10
Source: 1ClinicalTrials.gov – FDAAA 801 Requirements and FAQ, 2Health and Human Services – Final Rule
Deadlines‒ Responsible Party for ACT needs to submit
required trial information no later than 21 days after enrollment of first participant
‒ Results need to be submitted no later than 1 year after the primary completion date.– Delayed submission requests
• Certification• Extension Request
Source: 1ClinicalTrials.gov – FDAAA 801 Requirements and FAQ
Consequences‒ Fines
– Failing to comply with deadlines can result in monetary penalty of up to $10,000
– If violations not corrected within 30-days, in addition to any initial fine, the person may be subject to a $10,000 fine per day of violation until this violation is corrected
‒ Withholding of fund for federally funded studies
‒ UNMC - Suspension or withholding of approval for future studies
Source: 1Section 801 of the Food and Drug Administration Amendments Act, 2ClinicalTrials.gov – FDAAA 801 Requirements and FAQ
