Presentation on theme: "Orientation for New Clinical Research PERSONNEL Module 3"— Presentation transcript:
1 Orientation for New Clinical Research PERSONNEL Module 3 Welcome and introductions – thanks to contributors to presentationBathroomsPresented byNC TraCS InstituteUNC Office of Clinical TrialsUNC Network of Clinical Research Professionals
2 Overall Agenda for Orientation Module 1: Introduction to Clinical Research, Education, and IRBModule 2: Study Implementation, Documentation, and GCPsModule 3: Contracting, COI, and Hospital Administrative ElementsModule 4: Clinical Trial Management, Budgeting, Hospital and Research AccountingDiscuss that this Orientation Program has been divided into 4 separate days, consecutive Wednesdays, from 1-3pm. Review each of the weekly modules.Encourage attendees to attend all modules as most talks will offer something for everyone (always something to learn), but can skip some days if the topics don’t seem relevant to their research.
3 Conflict of Interest Joy Bryde, MSW Conflict of Interest Officer Research Compliance Program
4 Who is Covered by the Policy on Individual Conflicts of Interest (COI) and Commitment? Current Policy applies to all:University employees,students andtraineesin their performance of the teaching, research, public service, administration and business operations of the University, and in this context the individual may be referred to as a “Covered Individual”.Eights sections for Conflict of Interest, including Research
5 What is a COI?Conflict of interest is a situation in which financial or other personal considerations:may compromise,may involve the potential for compromising, ormay have the appearance of compromisingan employee’s objectivity in meeting University duties or responsibilities, including research activities. UNC Board of Governors Policy Manual
6 What is a COI ? (continued) The bias that such conflicts may impart can affect many University duties, including:decisions about personnel,the purchase of equipment and other supplies,the collection, analysis and interpretation of data,the sharing of research results,the choice of research protocols,the use of statistical methods,and the mentoring and judgment of student work.
7 Why the Conflict of Interest (COI) Process? Comply with UNC BOG policy and Federal requirements (funding, human subjects, conflict of interest, etc.)DHHS 42 CFR Part 50, 45 CFR Part 94 effective 08/24/ 2012Maintain academic mission and integrityHonor the student/trainee experienceAnd most importantlyProtect the credibility of the work that an individual is doing whether it is research or administrativeMantra: Disclose and Manage
8 Terms to know COI: conflict of interest FCOI: Financial Conflict of Interest means a Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.Financial Interest: anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); intellectual property rights (e.g., patents, copyrights, and royalties from such rights); gifts to directed benefit of an individual.Financial interest does not mean: salary from the University; income from seminars, lectures, or teaching engagements sponsored by or income from service on advisory committees or review panels for a US gov’t agency, a US institution of higher education, medical center, affiliated research center; mutual funds or blind trusts.NOTE: UNC’s definition to be used in place of Significant Financial Interest (SFI) in Federal RegulationsDisclosure: to submit to the University the details of any interests, financial or personal, that might be a potential conflict of interestDisclosure: to share details of a conflict of interest with subjects, a research team or in presentations or publications as necessary
10 Summary of Regulatory/Policy Changes Key Changes – IndividualMandatory training requirement every 4 years for all investigators involved in research (new) – UNC CH all individuals doing researchRequirement that institution determines if a disclosed financial interest is related to the employee’s institutional responsibilities (change from study responsibilities only)NIH definition for disclosure: De minimis threshold is lowered (to $5K), includes any equity, and scope of outside compensation subject to disclosure is broadened (now includes private non-profits)NOTE: UNC-CH definition requires $ value, of all relationships, even uncompensatedDisclosure for financial interests in the previous 12 months (new) and 12 months upcomingTimely disclosure of any changes in any financial interest must occur within 30 days (new)Paid authorship, royalties, copyrights, must be disclosed to institution regardless of source
11 Summary of Regulatory/Policy Changes Additional Requirements Individuals UNC-CH PHS ONLYTravel, reimbursed or covered, must be disclosed to institution (new) – some exclusions on source of sponsorshipDisclosure for paid authorship now includes textbooks (new)Institutional UNC-CH PHS ONLYSub-recipients must provide assurance of their own COI policy or fall under UNC’s policy (new)Public accessibility means the University must share certain limited information for PHS funded senior/key personnel with FCOIs through response to public written requests (new)Increased reporting requirements from institution to NIH (significantly more information to NIH including entity, role, $, management details)
12 How Does the COI Disclosure Process Work? Disclosure FormsTrigger events – created automatically by system upon submission into Ramses or IRBISAnnual – currently created and required for those people in administrative “influence” positionsNOTE: Will also be required for investigators in research positions beginning winter/spring 2013Self-identified need to disclose (intellectual property, gifts)Specific self generated forms (travel, book)Note: Investigators on PHS funded projects only
13 Research COI Disclosures IRB (IRBIS)Principal InvestigatorCo-investigatorFaculty AdvisorProject Manager or Study CoordinatorOSR (RAMSeS)Lead Principal InvestigatorInvestigatorPostdoctoral Research AssociateClinical Research CoordinatorIndependent Consultant InvestigatorDoes not trigger COI disclosures:Fellow, Graduate Research Assistant, Other Key Participant, Project Manager, Technical Staff, Undergraduate Student, Administrative Contact, Administrative AssistantDoes not trigger COI disclosures:Research Assistant, Regulatory Associate, Other (Read Only Access)
14 Why is a Disclosure Required for Each Study and Reviewed for a “Known” Conflict ? Federal regulationUniversity PolicyEach study is different even if the “conflict” appears to be the sameDifferent drugsDifferent protocolDifferent peopleResult – for human subjects research, informed consent text must be context specific
15 What Happens Next?No conflicts indicatedSystem filters every 10 minutesIRBIS/Ramses automatically updatedPotential conflicts indicatedInitial Evaluation at COI Office, usually further information is neededNext StepExpedited Review with Committee Chair(s) (Existing Management plans or <$10K) ORFull Committee (New conflict, >10K)NOTE: Five Standing COI Committees – Medicine, Public Health, Dentistry, Pharmacy and College of Arts & Sciences. Some committees meet 1x per month; others every 2-3 months.
16 Examples of Conflict Tangible Research Specific Financial - real or potential valueIncomeEquity/Stock/Options(mutual funds excluded)Royalties/licensing feesGifts (for self or others)Research SpecificResearch SponsorshipSBIR/STTRPurchasing/ContractingUse of institutional resources such as space or personnel to advance personal interests
17 Examples of Conflict Intangible Overconfidence about a particular conceptAcademic COI or Intellectual BiasDesire to validate a pet theoryOverreliance on a belief held by a special groupInternal or external pressures to get a specific resultResearch specificA reviewer responds positively to a manuscript because it presents results in which reviewer has a personal interestA reviewer delays publication of a competitor’s manuscriptAssignment of Students/TraineesRuling out data that doesn’t support a hypothesis
18 Management Principles & Tools Transparency“Significance” or value of interestIndependence of DataPublic DisclosureProtection of Human/Animal SubjectsProtection of Trainee ExperienceToolsManagement PlansPublic DisclosurePublicationsPresentationsResearch TeamHuman SubjectsIndependent Review PanelsChange in RolesMonitoring CommitteesFacilities Use AgreementsAlternative Options for TraineesAlternative Administrative RoutingNOTE: Significant financial interests presumed not allowable in human subjects research
19 Federal Anti-Kickback Statute Purpose: To protect patients and federal health care programs from fraud and abuseSummary: Prohibits the solicitation, receipt, offer or payment of remuneration “in return for” or “to induce” the referral of program related business, arranging for, or recommending, the purchase, lease, or ordering of any item or service reimbursed by a federal healthcare programPenaltiesCivil: Fines up to $50,000; Exclusion from federal health care programsCriminal: Felony; Up to five years in prison; Fines up to $25,000
20 Anti-Kickback: Trial Risks & Solutions Direct payments to investigatorsInstitutional financial managementIncentives for investigators (i.e. exotic meeting locations)Institutional contractingUnbudgeted paymentsFinancial COIPublished and enforced COI policiesStudy biases (i.e. site selection, prescribing, …)IRB and trainingExcess fundsFair market value pricingPublished policies on the disposition of excess fundsStudy meritIRB review and approval
21 UNC-CH CONFLICT OF INTEREST POLICY IS STRICTER THAN FDA Stricter definition of significant financial interestProject-by-project disclosure of financial and other conflicts of interestAny changes to financial and other interests must be reported within 30 days.Rules regarding compensation from Sponsors
22 Rules regarding Compensation from Sponsors University employees may not accept gifts, payments, or in-kind support (including but not limited to financial payments, gift certificates, books, conference attendance and payment of travel expenses)as inducements for performance in a University projectexcept as expressly included in budgeted project costs in a contract between the University and the project sponsor.
23 FDA Investigator Financial Disclosure This disclosure requires that the Principal Investigator certifies that s/he does not have a significant financial holding in the company with which he wishes to contract.This helps to avoid conflict of interest situations in which the Investigator’s data may be called into question because of financial interest in the company.
25 Contact InformationJoy M. Bryde, MSWConflict of Interest OfficerAssistant Director, Institutional Research ComplianceMailing Address: Research Compliance ProgramUNC-CH CB 9103Physical Address: 137 E. Franklin St. Suite 501 BOACPhone: (919)Website:General for questions:Websites: air.unc.edu (items created after August 24, 2012)coi-training.unc.educoi.unc.edu epap.unc.edu (items created before August 24, 2012)
27 Learning Objectives Define what is a contract Understand what are clinical trial agreements (CTAs) and why you need themKnow the typical content of a CTAUnderstand some contract issues and processes related to the CTA that are relevant to the PI and CoordinatorUnderstand what is the role of the Office of Clinical Trials in negotiating CTAs
28 Basic Definition Contract An agreement between two or more parties outlining the responsibilities, duties, and rights of each partySponsor agreements typically have standard, template language for uniformity that may be difficult to change
29 Clinical Trial Contracts Agreements Associated with Clinical Trials Clinical Trial Agreement (CTA)Sponsor-initiatedInvestigator-initiatedConfidential Disclosure Agreement (CDA)Consortium/Network/Collaboration AgreementsMaterial Transfer Agreement (MTA)Equipment Loan AgreementSubcontracts to sub-Sites and collaboratorsAll negotiated and signed by Office of Clinical Trials (OCT); important to get an early start, and involve OCT from the beginning!
30 CTA What is a Clinical Trial Agreement (CTA)? A legally binding agreement that manages the relationship between the sponsor/funding source and institutionSponsor/funding source may be providing:Study drug or deviceFinancial supportAnd/orProprietary informationInstitution [UNC]/PI may be providing:Data and/or resultsPublication, input into publicationIntellectual property, input into intellectual property
31 CTA Why is it Important to Have a CTA? For both sponsor/funding source and institution:Protection of:Rights (academic, legal, and intellectual property)Integrity (academic and scientific)Allocation of:ResponsibilityMoneyObligationsRisk
32 CTA Reviewing and Negotiating CTAs OCT, under the Vice Chancellor for Research, provides review and negotiation, if necessary, for CTAs:Location:720 Martin Luther King Jr. Blvd, Suite 100, CB# 1651General phone:Associate Director:Aylin Regulski MS, JD,
33 CTA OCT’s Negotiation Goals Minimize legal risks and obligations to University and PIEnsure compliance with all applicable federal and state laws and regulations, and University policies and guidelinesHelp PI and department not be saddled with unreasonable requirementsDefine operational parameters for PIe.g., timelines for data submission, registration and posting of study results on clinicaltrials.gov, study termination, recordkeeping
34 CTA Content of Typical CTA (not an exhaustive list) Parties to the ContractPreamblePurpose, Protocol/Statement of WorkUse of CRO’sConformance with Applicable laws, Enrollment, Reporting/ Meeting RequirementsCommunication of results to site/subjectConfidential InformationOwnership & Use of Data/ Biological SpecimensIntellectual Property/ CopyrightsPublicationsEthics CommitteeDebarment CertificationAccess to Premises/AuditsCode of Ethics (CIA’s)Changes/AmendmentsRecordkeeping, Retention/DestructionElectronic Data/SignaturesIndemnification by SponsorCross Indemnification by SiteSubject Injury and MSP ReportingInsuranceBreach, Remedies and WaiversReturn/Destruction of Study MaterialsPurchase/Supply, Shipping, Use, Maintenance, Risk of Loss & Disposition of EquipmentHIPAANoncompetition/ Freedom to ContractTerm and Termination/ Payment in Event of Termination/ CloseoutNotices and Notice TimelinesPublicity/Use of Names and Personal Information, AdvertisingAssignment/ DelegationSurvival of ObligationsChoice of Law, Venue, Arbitration, MediationBilling, Invoicing, AdjustmentsBudget and Payment SchedulesBolded items: Some selected items of relevance to investigators
35 CTA Content Parties to the Contract Names the parties and their legal addressesParties are the sponsor and UniversityPI is NOT a party to the agreementPI signs agreement only as acknowledging (or as “read and understood”) his/her obligations outlined in the agreement (including CDA)
36 CTA Content Protocol/Statement of Work Investigator conducts study according to the protocolNeed enough detail for very clear understanding of research, conduct and deliverables (e.g., data, reports)Investigator-initiated studies: PI is sponsorHas all the regulatory and oversight obligations of a sponsor (sponsor-investigator)Make sure the protocol/statement of work (SOW) is very clear!
37 CTA Content Communication of Results to Site/Subject Notification requirements between sponsor and site where subject safety, care, or willingness to participate may be impacted by information found during monitoring or data collectionEven after study has endedPI requirement to notify subjectsCommunication is subject to IRB approval
38 CTA Content Confidential Information What is considered to be confidential information and to whom?Unilateral obligations: Typically UNC/PI owes the obligations to potential sponsor; not reciprocatedBilateral obligations: Confidentiality obligations run both waysWho has access to Confidential Information at site?PI and study teamResearch support offices (OCT, IRB, Office of University Council, Research Compliance Office, may include others)Duration of confidentiality obligation/exceptions to confidentialityMay restrict ability to publish
39 CTA Content Control and Use of Data/Biospecimens Property is a bundle of rightsImportant issue: Who can do what with the information related to the study?Sponsor “owns” and prevents University from sharing with 3rd parties:Case Report Forms (CRFs)Study results (University must carve out right to use results/data)University “owns” and gives Sponsor limited right to use:Subject medical recordsResearch notebooksSponsors take this issue very seriously!
40 CTA Content Control and Use of Data/Biospecimens For industry-initiated studies, University gets to use results/data for:Own internal research, educational, and patient care purposesPublication, in accordance with terms of contractFor investigator-initiated studies, important to negotiate:Who owns the data?Protect ability of PI to use the data to publish and to seek funding for future studiesThe ability to store and use biospecimens collected during a study may be an issue
41 CTA Content Intellectual Property (IP)/Copyrights Protected by patentsLicenses can be: exclusive or non-exclusive; royalty bearing or royalty free; right to sub-license or notIndustry-initiated studiesImportant goal is to protect PI’s background IPInvestigator-initiated studiesUNC may retain rights to IP it develops and grant industry funder the first option to enter into a royalty bearing license agreement. OCT may seek input from PIPlease make sure OCT is aware if you have additional funding for your study from other sources (e.g., Federal, Industry, Foundation)
42 CTA Content Publications Importance of publication to University:Closely linked to “academic freedom”/tax exempt missionHelps to establish PI’s expertise in field and build connectionsUniversity concern: sponsor’s editorial control and publication delayRegistry requirement must be met in order to preserve ability to publishClinicaltrials.gov
43 CTA Content—Publications Sponsor’s Rights and Concerns Sponsor’s concerns regarding publicationsTiming of publicationsTime and ability to review and commentDelete “Confidential Information”Request delay for patent filingFor multi-center publications:Sponsor’s concern about misleading results from single site (PI may request access to multi-site data)Sponsor may NOT with respect to publications:Have editorial rightsDelay publication unreasonably/indefinitely
44 CTA Content Recordkeeping, Retention/Destruction Contract specifies:How long records must be keptHow they will be storedWhen they can be returned/destroyedUniversity must retain a copy of recordsSponsors typically want long retention and storage obligations
45 CTA Content Indemnification by Sponsor Protects Institution, hospital, and respective employees from study-related claims/ lawsuitsFollowing notice provisions, following the protocol, exercising sound medical judgment, reporting adverse events, complying with applicable regulations, and good recordkeeping are important to preserve rights to indemnification
46 CTA Content Subject Injury in Industry-Initiated Trials Sponsor covers cost of care and treatment of research-related injuries (RRIs) to subjectsCovers Injuries directly related to use of investigational product or protocol proceduresWho decides if study participation caused injury may be a contractual issueSubject injury payment wording in CTA and informed consent must be consistent!Department, IRB, and OCT need to coordinate to provide consistency (make sure to use the appropriate template language in the informed consent)
47 CTA Content—Subject Injury Medicare Secondary Payor (MSP) Reporting Requirements Medicare Reporting:Medicare Secondary Payer (MSP): Mandatory reporting provisions of MMSEA statute make Medicare secondary to certain other types of insuranceCenter for Medicare & Medicaid Services (CMS) alert: Issued May states that sponsors who make payments for injuries arising from clinical trials are considered self-insurance programs subject to MSP reportingSponsor’s obligations to verify Medicare status and report subject-identifiable information (e.g., social security number [SSN]) to CMS are only triggered when:Sponsor has agreed to be responsible for medical expensesResearch subject is injured; andClaim is made for payment of expenses relating to injurySponsor collects subjects’ SSNs for reporting purposesNeeds to be indicated in consent form and CTA
48 CTA Content Term and Termination/Payment in Event of Termination Term: How long is the agreement in effect?Fixed with provisions for extensionOpen, based on duration of studyTermination: Who can quit and under what conditions?Termination rights may not always be mutualPayment in the event of early terminationNonrefundable start-up costsExpenses incurredNon-cancellable obligationsShut down/transfer expenses
49 CTA Content Notices and Notice Timelines Even though you notify sponsor of important events, it may not legally count as notice under your contractThe contract language matters!Notices: Who to notify, who to copy, how to notifyThroughout contract: When to notifyEvents trigger timelines (e.g., you become aware of a study related legal claim, there is an adverse event, subject is injured, someone working on the study is debarred or under investigation for debarment, you find out you are going to be audited, there is a breach of a confidentiality obligation, you have a discovery or invention)
50 Final Helpful Hints About Clinical Trial Contracts Get your Review Request Form (RRF)/submission to OCT as soon as possible to begin the reviewing and negotiating processWork with OCT to provide important information and to revise the contract as necessary for your studyBefore signing, read carefully again, paying close attention to:Final budget to ensure it is the one you agreed toAny study specific revisions you may have requested of OCTYour obligations under the agreementRemember each contract negotiation process is unique
51 Don’t Forget… READ THE CONTRACT before signing! Call OCT if you have questions!Aylin Regulski, Associate Director OCT
52 Trial Registration at ClinicalTrials.gov: FDA and ICMJE Monica CoudurierOffice of Clinical Trials
53 What is ClinicalTrials.gov? Web based registry that provides regularly updated information about federally and privately supported clinical trialsFirst version publicly available February 29, 2000Each record provided in ClinicalTrials.gov includes the following:Disease or condition and experimental treatments studiedTitle, description, and design of studyRequirements for participationLocation(s) where the study is availableOverall study statusRecruitment contact informationLinks to relevant information at other health Web sites, such MedlinePlus and PubMed
54 The International Committee of Medical Journal Editors (ICMJE) Policy Per the ICMJE, any trial meeting the following definition of “clinical trial” must be registered to be considered for publication:Health-related interventions include any intervention used to modify a biomedical or health-related outcome (e.g., drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
55 What Trials Must be Registered? (PHS Act/Code of Federal Regulations) Trials that must be registered are called “Applicable Clinical Trials” (ACTs), these trials generally include:Trials of Drugs and Biologics: Controlled, clinical investigations, (other than Phase 1 investigations), of a product subject to FDA regulation (If efficacy is an endpoint of Phase I study, it must be registered).Trials of Devices: Controlled trial with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance.NIH requires registration of trials meeting FDA requirement; encourages registration of ALL trials whether required under the law or not.
56 What Studies Require Data Results? FDAAA 801 (effective Sept. 27, 2008) expanded registry and added results database:to include reporting of results for those trials that meet the definition of “Applicable Clinical Trial” (regardless of whether the study has an IND or IDE)Serious Adverse Event reporting (effective Sept. 27, 2009)
57 Who is Responsible for Registering Trials? Clinicaltrials.gov registration is the responsibility of the trial sponsor:UNC Investigator initiates and sponsors trial – PI registersTrial in which PI obtains industry fundsNIH or other grant funded trial (external or internal grants)UNC PI holds an IND or IDEIndustry initiated/sponsored trial – Industry sponsor registersIf UNC PI must register on CT.gov:CT.gov user account set-up and record assistance available through the UNC Office of Clinical Trials- contact Monica Coudurier at orAmy Franklin (TraCS) at for LCCC/Oncology studies
58 Deadlines for Registering Trials ICMJE Policy – Study must be registered prior to enrollment of first subject.If an investigator wants to publish the dataactice should be followedPHS Act – Study must be registered no later than 21 days after enrollment of the first subject.This is required by US Public Law and must be done
59 Record Upkeep: Following Registration 4/13/2017Record Upkeep: Following RegistrationEnsure the information is complete, accurate, and updated every 6 months or as changes occurReview the record and update as necessaryActive trials (Not yet recruiting; Recruiting; Enrolling by Invitation; Active, not recruiting)Update status when enrollment ceasesProvide Results within 1 year of completion of Primary (Outcome Measure) Completion or Study Completion
60 Monetary PenaltiesWhat are the penalties for failing to register an “Applicable Clinical Trial?” Penalties for responsible parties who fail to register, or provide false or misleading information in connection with, applicable clinical trials are significant and may include civil monetary penalties (up to $10,000 per day) and, for federally-funded trials, the withholding or recovery of grant funds. See PL , Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and new 21 U.S.C. 331(jj).
61 Investigational Drug Service (IDS) Sue Pope, Manager, UNC IDS
62 IDS Operational Overview IDS staff3 Pharmacist and 4 Technician FTEsStudies managedOver 250 total studies managed annuallyIDS hours of operation0730 to 1600 Monday through FridayIDS is closed on major hospital and university holidaysLocations3rd floor Memorial Hospital - Prepares medications for protocols that contain chemotherapy agents or IV productsGround floor Neurosciences Hospital- Prepares medications for protocols that only contain oral, non-chemotherapy medications3rd floor North Carolina Cancer HospitalMain points – 3 locations for IDS (one site for IV meds, one for oral meds, and Cancer Hospital location)
63 IDS Staff LEADERSHIP Sue Pope, RPh Manager, Investigational Drug ServicePager: , Office:Scott Savage, PharmD, MSAssistant Director of Ambulatory CarePager:PHARMACISTSLinda Manor, RPh - PharmacistDave Stines, PharmD, MS - PharmacistAmelia Stokely, RPh - PharmacistGENERAL CONTACT INFORMATION3W IDS (Memorial Hospital)Fax number for orders:NS IDS (Neurosciences Hospital)Fax number for orders:IN AN EMERGENCY:Outside of normal business hours – IDS maintains an on-call pagerIn an emergency, an IDS clinical pharmacist can be reached by dialing and will provide assistance with-Individual drug or research questionsThe breaking of a treatment blindProvide support for inpatient or IV room staff who may be unfamiliar with a particular research protocolContact info – not going over other than to say that Sue Pope is the manager. Keep this slide as a resource when looking for contact info.They do have an emergency # to call at off hours – unblinding, needing drug prepared in emergency (done by hospital pharmacist with IDS instructions)
64 Investigational Drug Service Memorial Hospital, 3rd Floor(fax for orders)Prepares medications for protocols that contain chemotherapy agents or IV productsNeurosciences Hospital, Ground Floor(fax for orders)Prepares medications for protocols that only contain oral, non-chemotherapy medicationsSummary slide
65 Do I need to use IDS for my research protocol? For research protocols within the Hospital system, the clinical and distributional services of IDS are requiredIDS Pharmacy is required to be involved with all investigational studies that use an agent/drugJoint Commission Medication Management standardsAn agent/drug (including supplements) will be considered investigational, if following two criteria met:Administration of the agent is part of protocol which requires IRB approvalA subject is required to sign an Informed Consent Form before receiving the agentStudy locations other than main Hospital (e.g. Southern Village, Carrboro Dialysis, UNC School of Dentistry, EPA, etc)Answer is “Yes” in most cases!!Includes drugs that are FDA approved for use if given as part of research protocol.In addition to giving drugs in the hospital, same requirement for using IDS if UNC HealthCare associated site – outlying clinics, School of Dentistry, EPA.Special process for getting approval at outlying sites – IDS will evaluate your site to determine if can store drug at your location and dispense. Not always okay and would then make arrangements for delivery or your pick up in advance of day.
66 How and when do I initiate a request for IDS services? As a general rule, contract negotiation with the Office of Clinical Trials (OCT), request for IRB approval, and request for IDS services should be initiated simultaneouslyIDS needs notification 6 to 8 weeks prior to 1st study subject enrollmentUse Clinical Research Management System (CRMS) to submit protocol materials to IDSOr, mail a completed IDS Request for Services (RFS) form, an Intensity Worksheet, as well as copy of the protocol to the address belowInvestigational Drug Service3rd Floor Main HospitalDepartment of PharmacyCB 7600*See supplemental information for internal IDS process
67 What do the services of the IDS cost? Complexity of protocol determines extent of IDS services used.Protocol Intensity Worksheet uses a fee for service pricing structure to determine budget for study.Score the protocol with a point based system to determine the level of service4 levels of service - the level determines the start up and monthly fee.One time start up fee, non-refundable, charged as soon as notebook is ready for dispensing.Once drug is received and on the shelf, IDS begins billing monthly fee.IDS ceases to bill when the drug has been removed from the pharmacy and a final pharmacy close out visit has been conducted.Need worksheet before IDS can process memo for IRB.Protocol Intensity Worksheet when completed determines the IDS fees for a study. As not all clinical studies are the same – some meds require more work to prepare, store, and dispense – study is evaluated and given one of 4 levels of service.Once drug received, on shelf in IDS, monthly fee is billed. Don’t forget that monthly fee continues until drug removed from pharmacy AND pharmacy close out visit conducted. So, make sure that is done promptly.
68 What types of products can be compounded by IDS? IDS can participate in treatment and placebo blinding for solid oral dosage formsMore complex compounding (liquid formulations, suppositories, troches, patches, etc) are outsourced to a local compounding pharmacyCompounding fees of the local pharmacy apply in addition to standard IDS feesIDS can actually do compounding which involves making placebos / blinding of drugs and also mixing formulations. Some compounding too complex and sent out. If this involves your study, talk to pharmacy up front to determine all costs involved.
69 How are research protocols handled outside of normal business hours? Approximately 95% of our research protocols are handled during normal business hours (M-F, 0730 to 1600)However, if your research protocol will require after hour dispensation, your assigned pharmacist can coordinate this with our inpatient or IV roomYour IDS pharmacist will coordinate delivery and storage of materials to the IV room/Inpatient Pharmacy as well as provide necessary inservices to the staffAs mentioned, IDS staff here during normal business hours, but they can make arrangements for services outside these hours and on holidays with ADVANCED notice (and occasionally in an emergency – just don’t abuse that).
70 Scheduling a Monitoring Visit In an effort to accommodate our sponsors, all visits (e.g., monitoring visits, initiation visits etc) must be coordinated with your assigned pharmacist or through the IDSCalling or or (CHIP)2 monitoring visits per day per IDS work areaScheduled typically a month or more in advance“Remote” monitoring visits are typically not supported by IDSMake sure to plan ahead as they can’t accommodate all monitors at same time with the limited space they have.
71 To whom and where can Clinical Trial Materials (CTM) be sent? After contacting IDS ( ) to make them aware of the incoming shipment as well as total volume of expected shipment, CTMs can be directed to the following address:Investigational Drug Services3rd Floor, Room N3122101 Manning DriveChapel Hill, NC 27514Phone: Fax:Where to have your study drug sent. Again, keeping IDS in the loop on deliveries is a nice courtesy so they can have prepared space for the materials – freezer, shelf, etc.
72 How are Investigational Medications Dispensed? IDS can begin preparing an investigational medication foryour patient ONLY when:Completed protocol orders are faxed to 3W IDS or NS IDS PharmacyOrders must be signed by provider listed on 1572 and IRB application (original signature, not a copy)Coordinator must give IDS verbal confirmation that patient is available for treatment (if pertinent to protocol)Coordinators must present an original signed prescription order when picking up an investigational medication in the IDS pharmacy.Fax or hand deliver orders. Make sure MD signature is an ORIGINAL! Don’t have MD sign one order and then make multiple copies as that isn’t legal. IDS can’t always tell they have been given copies as not visible if faxed in.
74 OverviewThe University of North Carolina Health Care System must ensure compliance with regard to utilization of investigational devices.There is a policy that governs:Administrative ProceduresDevice ReceiptDevice StorageDevice Use/DispensingDevice Return
75 Administrative Procedures Prior to use of an investigational device, the following has to occur:IRB approvalFinal sponsor budget- will sponsor provide device free of cost or must UNC Hospitals purchase? (contact Hospital Purchasing)Contract must be fully executed (UNC Office of Clinical Trials)Must have #98 account number (UNC Hospitals’ Patient Accounting Office)Notify UNC HCS Reimbursement of pending trial. They will coordinate with Medicare Fiscal Intermediary.
76 Receipt, Storage, Use/Dispensing, Return Device Receipt-What Does Protocol say?Request Sponsor to notify of shipmentComply with Sponsor documentation requirementsDevice Storage-Secure, segregated, clearly identified as investigationalDevice Use/Dispensing-Record use/dispensing informationDevice Return-Read clinical trial agreement to see if contract terms governRecord informationWork with UNC Hospital Purchasing to return unused devices.
77 For a copy of this presentation & additional helpful information Please VISITFor a copy of this presentation & additional helpful informationTRACS.UNC.edU / RESEARCH CENTRALThe website where you can access a copy of the slides.Many resources available on the website
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