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Orientation for New Clinical Research PERSONNEL Module 3

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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 presentation Bathrooms Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals

2 Overall Agenda for Orientation
Module 1: Introduction to Clinical Research, Education, and IRB Module 2: Study Implementation, Documentation, and GCPs Module 3: Contracting, COI, and Hospital Administrative Elements Module 4: Clinical Trial Management, Budgeting, Hospital and Research Accounting Discuss 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 and trainees in 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, or may have the appearance of compromising an 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/ 2012 Maintain academic mission and integrity Honor the student/trainee experience And most importantly Protect the credibility of the work that an individual is doing whether it is research or administrative Mantra: 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 Regulations Disclosure: to submit to the University the details of any interests, financial or personal, that might be a potential conflict of interest Disclosure: to share details of a conflict of interest with subjects, a research team or in presentations or publications as necessary

9 COI Snapshot FCOIs COIs COI Disclosure COI Training

10 Summary of Regulatory/Policy Changes
Key Changes – Individual Mandatory training requirement every 4 years for all investigators involved in research (new) – UNC CH all individuals doing research Requirement 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 uncompensated Disclosure for financial interests in the previous 12 months (new) and 12 months upcoming Timely 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 ONLY Travel, reimbursed or covered, must be disclosed to institution (new) – some exclusions on source of sponsorship Disclosure for paid authorship now includes textbooks (new) Institutional UNC-CH PHS ONLY Sub-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 Forms Trigger events – created automatically by system upon submission into Ramses or IRBIS Annual – currently created and required for those people in administrative “influence” positions NOTE: Will also be required for investigators in research positions beginning winter/spring 2013 Self-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 Investigator Co-investigator Faculty Advisor Project Manager or Study Coordinator OSR (RAMSeS) Lead Principal Investigator Investigator Postdoctoral Research Associate Clinical Research Coordinator Independent Consultant Investigator Does not trigger COI disclosures: Fellow, Graduate Research Assistant, Other Key Participant, Project Manager, Technical Staff, Undergraduate Student, Administrative Contact, Administrative Assistant Does 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 regulation University Policy Each study is different even if the “conflict” appears to be the same Different drugs Different protocol Different people Result – for human subjects research, informed consent text must be context specific

15 What Happens Next? No conflicts indicated System filters every 10 minutes IRBIS/Ramses automatically updated Potential conflicts indicated Initial Evaluation at COI Office, usually further information is needed Next Step Expedited Review with Committee Chair(s) (Existing Management plans or <$10K) OR Full 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 value Income Equity/Stock/Options (mutual funds excluded) Royalties/licensing fees Gifts (for self or others) Research Specific Research Sponsorship SBIR/STTR Purchasing/Contracting Use of institutional resources such as space or personnel to advance personal interests

17 Examples of Conflict Intangible
Overconfidence about a particular concept Academic COI or Intellectual Bias Desire to validate a pet theory Overreliance on a belief held by a special group Internal or external pressures to get a specific result Research specific A reviewer responds positively to a manuscript because it presents results in which reviewer has a personal interest A reviewer delays publication of a competitor’s manuscript Assignment of Students/Trainees Ruling out data that doesn’t support a hypothesis

18 Management Principles & Tools
Transparency “Significance” or value of interest Independence of Data Public Disclosure Protection of Human/Animal Subjects Protection of Trainee Experience Tools Management Plans Public Disclosure Publications Presentations Research Team Human Subjects Independent Review Panels Change in Roles Monitoring Committees Facilities Use Agreements Alternative Options for Trainees Alternative Administrative Routing NOTE: 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 abuse Summary: 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 program Penalties Civil: Fines up to $50,000; Exclusion from federal health care programs Criminal: Felony; Up to five years in prison; Fines up to $25,000

20 Anti-Kickback: Trial Risks & Solutions
Direct payments to investigators Institutional financial management Incentives for investigators (i.e. exotic meeting locations) Institutional contracting Unbudgeted payments Financial COI Published and enforced COI policies Study biases (i.e. site selection, prescribing, …) IRB and training Excess funds Fair market value pricing Published policies on the disposition of excess funds Study merit IRB review and approval

Stricter definition of significant financial interest Project-by-project disclosure of financial and other conflicts of interest Any 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 project except 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 Information Joy M. Bryde, MSW Conflict of Interest Officer Assistant Director, Institutional Research Compliance Mailing Address: Research Compliance Program UNC-CH CB 9103 Physical Address: 137 E. Franklin St. Suite 501 BOAC Phone: (919) Website: General for questions: Websites: (items created after August 24, 2012) (items created before August 24, 2012)

26 clinical trial Contracts
Aylin Regulski, MS, JD, Associate Director, Office of Clinical Trials

27 Learning Objectives Define what is a contract
Understand what are clinical trial agreements (CTAs) and why you need them Know the typical content of a CTA Understand some contract issues and processes related to the CTA that are relevant to the PI and Coordinator Understand 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 party Sponsor 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-initiated Investigator-initiated Confidential Disclosure Agreement (CDA) Consortium/Network/Collaboration Agreements Material Transfer Agreement (MTA) Equipment Loan Agreement Subcontracts to sub-Sites and collaborators All 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 institution Sponsor/funding source may be providing: Study drug or device Financial support And/or Proprietary information Institution [UNC]/PI may be providing: Data and/or results Publication, input into publication Intellectual 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: Responsibility Money Obligations Risk

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# 1651 General phone: Associate Director: Aylin Regulski MS, JD,

33 CTA OCT’s Negotiation Goals
Minimize legal risks and obligations to University and PI Ensure compliance with all applicable federal and state laws and regulations, and University policies and guidelines Help PI and department not be saddled with unreasonable requirements Define operational parameters for PI e.g., timelines for data submission, registration and posting of study results on, study termination, recordkeeping

34 CTA Content of Typical CTA (not an exhaustive list)
Parties to the Contract Preamble Purpose, Protocol/Statement of Work Use of CRO’s Conformance with Applicable laws, Enrollment, Reporting/ Meeting Requirements Communication of results to site/subject Confidential Information Ownership & Use of Data/ Biological Specimens Intellectual Property/ Copyrights Publications Ethics Committee Debarment Certification Access to Premises/Audits Code of Ethics (CIA’s) Changes/Amendments Recordkeeping, Retention/Destruction Electronic Data/Signatures Indemnification by Sponsor Cross Indemnification by Site Subject Injury and MSP Reporting Insurance Breach, Remedies and Waivers Return/Destruction of Study Materials Purchase/Supply, Shipping, Use, Maintenance, Risk of Loss & Disposition of Equipment HIPAA Noncompetition/ Freedom to Contract Term and Termination/ Payment in Event of Termination/ Closeout Notices and Notice Timelines Publicity/Use of Names and Personal Information, Advertising Assignment/ Delegation Survival of Obligations Choice of Law, Venue, Arbitration, Mediation Billing, Invoicing, Adjustments Budget and Payment Schedules Bolded items: Some selected items of relevance to investigators

35 CTA Content Parties to the Contract
Names the parties and their legal addresses Parties are the sponsor and University PI is NOT a party to the agreement PI 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 protocol Need enough detail for very clear understanding of research, conduct and deliverables (e.g., data, reports) Investigator-initiated studies: PI is sponsor Has 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 collection Even after study has ended PI requirement to notify subjects Communication 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 reciprocated Bilateral obligations: Confidentiality obligations run both ways Who has access to Confidential Information at site? PI and study team Research support offices (OCT, IRB, Office of University Council, Research Compliance Office, may include others) Duration of confidentiality obligation/exceptions to confidentiality May restrict ability to publish

39 CTA Content Control and Use of Data/Biospecimens
Property is a bundle of rights Important 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 records Research notebooks Sponsors 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 purposes Publication, in accordance with terms of contract For 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 studies The ability to store and use biospecimens collected during a study may be an issue

41 CTA Content Intellectual Property (IP)/Copyrights
Protected by patents Licenses can be: exclusive or non-exclusive; royalty bearing or royalty free; right to sub-license or not Industry-initiated studies Important goal is to protect PI’s background IP Investigator-initiated studies UNC 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 PI Please 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 mission Helps to establish PI’s expertise in field and build connections University concern: sponsor’s editorial control and publication delay Registry requirement must be met in order to preserve ability to publish

43 CTA Content—Publications Sponsor’s Rights and Concerns
Sponsor’s concerns regarding publications Timing of publications Time and ability to review and comment Delete “Confidential Information” Request delay for patent filing For 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 rights Delay publication unreasonably/indefinitely

44 CTA Content Recordkeeping, Retention/Destruction
Contract specifies: How long records must be kept How they will be stored When they can be returned/destroyed University must retain a copy of records Sponsors typically want long retention and storage obligations

45 CTA Content Indemnification by Sponsor
Protects Institution, hospital, and respective employees from study-related claims/ lawsuits Following 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 subjects Covers Injuries directly related to use of investigational product or protocol procedures Who decides if study participation caused injury may be a contractual issue Subject 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 insurance Center 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 reporting Sponsor’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 expenses Research subject is injured; and Claim is made for payment of expenses relating to injury Sponsor collects subjects’ SSNs for reporting purposes Needs 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 extension Open, based on duration of study Termination: Who can quit and under what conditions? Termination rights may not always be mutual Payment in the event of early termination Nonrefundable start-up costs Expenses incurred Non-cancellable obligations Shut 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 contract The contract language matters! Notices: Who to notify, who to copy, how to notify Throughout contract: When to notify Events 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 process Work with OCT to provide important information and to revise the contract as necessary for your study Before signing, read carefully again, paying close attention to: Final budget to ensure it is the one you agreed to Any study specific revisions you may have requested of OCT Your obligations under the agreement Remember 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 FDA and ICMJE
Monica Coudurier Office of Clinical Trials

53 What is
Web based registry that provides regularly updated information about federally and privately supported clinical trials First version publicly available February 29, 2000 Each record provided in includes the following: Disease or condition and experimental treatments studied Title, description, and design of study Requirements for participation Location(s) where the study is available Overall study status Recruitment contact information Links 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? registration is the responsibility of the trial sponsor: UNC Investigator initiates and sponsors trial – PI registers Trial in which PI obtains industry funds NIH or other grant funded trial (external or internal grants) UNC PI holds an IND or IDE Industry initiated/sponsored trial – Industry sponsor registers If UNC PI must register on user account set-up and record assistance available through the UNC Office of Clinical Trials- contact Monica Coudurier at or Amy 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 data actice should be followed PHS 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
4/13/2017 Record Upkeep: Following Registration Ensure the information is complete, accurate, and updated every 6 months or as changes occur Review the record and update as necessary Active trials (Not yet recruiting; Recruiting; Enrolling by Invitation; Active, not recruiting) Update status when enrollment ceases Provide Results within 1 year of completion of Primary (Outcome Measure) Completion or Study Completion

60 Monetary Penalties What 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 staff 3 Pharmacist and 4 Technician FTEs Studies managed Over 250 total studies managed annually IDS hours of operation 0730 to 1600 Monday through Friday IDS is closed on major hospital and university holidays Locations 3rd floor Memorial Hospital - Prepares medications for protocols that contain chemotherapy agents or IV products Ground floor Neurosciences Hospital- Prepares medications for protocols that only contain oral, non-chemotherapy medications 3rd floor North Carolina Cancer Hospital Main 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 Service Pager: , Office: Scott Savage, PharmD, MS Assistant Director of Ambulatory Care Pager: PHARMACISTS Linda Manor, RPh - Pharmacist Dave Stines, PharmD, MS - Pharmacist Amelia Stokely, RPh - Pharmacist GENERAL CONTACT INFORMATION 3W 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 pager In an emergency, an IDS clinical pharmacist can be reached by dialing and will provide assistance with- Individual drug or research questions The breaking of a treatment blind Provide support for inpatient or IV room staff who may be unfamiliar with a particular research protocol Contact 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 products Neurosciences Hospital, Ground Floor (fax for orders) Prepares medications for protocols that only contain oral, non-chemotherapy medications Summary 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 required IDS Pharmacy is required to be involved with all investigational studies that use an agent/drug Joint Commission Medication Management standards An agent/drug (including supplements) will be considered investigational, if following two criteria met: Administration of the agent is part of protocol which requires IRB approval A subject is required to sign an Informed Consent Form before receiving the agent Study 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 simultaneously IDS needs notification 6 to 8 weeks prior to 1st study subject enrollment Use Clinical Research Management System (CRMS) to submit protocol materials to IDS Or, mail a completed IDS Request for Services (RFS) form, an Intensity Worksheet, as well as copy of the protocol to the address below Investigational Drug Service 3rd Floor Main Hospital Department of Pharmacy CB 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 service 4 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 forms More complex compounding (liquid formulations, suppositories, troches, patches, etc) are outsourced to a local compounding pharmacy Compounding fees of the local pharmacy apply in addition to standard IDS fees IDS 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 room Your IDS pharmacist will coordinate delivery and storage of materials to the IV room/Inpatient Pharmacy as well as provide necessary inservices to the staff As 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 IDS Calling or or (CHIP) 2 monitoring visits per day per IDS work area Scheduled typically a month or more in advance “Remote” monitoring visits are typically not supported by IDS Make 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 Services 3rd Floor, Room N3122 101 Manning Drive Chapel Hill, NC 27514 Phone:  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 for your patient ONLY when: Completed protocol orders are faxed to 3W IDS or NS IDS Pharmacy Orders 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.

73 UNC Investigational Device Policy
Aylin Regulski, MS, JD, Associate Director, Office of Clinical Trials

74 Overview The University of North Carolina Health Care System must ensure compliance with regard to utilization of investigational devices. There is a policy that governs: Administrative Procedures Device Receipt Device Storage Device Use/Dispensing Device Return

75 Administrative Procedures
Prior to use of an investigational device, the following has to occur: IRB approval Final 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 shipment Comply with Sponsor documentation requirements Device Storage- Secure, segregated, clearly identified as investigational Device Use/Dispensing- Record use/dispensing information Device Return- Read clinical trial agreement to see if contract terms govern Record information Work with UNC Hospital Purchasing to return unused devices.

77 For a copy of this presentation & additional helpful information
Please VISIT For a copy of this presentation & additional helpful information TRACS.UNC.edU / RESEARCH CENTRAL The website where you can access a copy of the slides. Many resources available on the website

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