ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL

MODULE 3

Presented by

NC TraCS InstituteUNC Office of Clinical Trials

UNC Network of Clinical Research Professionals

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

CONFLICT OF INTERESTJoy Bryde, MSW

Conflict of Interest Officer

Research Compliance Program

jbryde@unc.edu

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

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

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.

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

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

COI Snapshot

FCOIs

COIs

COI Disclosure

COI Training

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

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)

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

Research COI Disclosures

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)

IRB (IRBIS)

Principal Investigator

Co-investigator

Faculty Advisor

Project Manager or Study Coordinator

OSR (RAMSeS)Lead Principal Investigator

Principal Investigator

Investigator

Postdoctoral Research Associate

Clinical Research Coordinator

Independent Consultant Investigator

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

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.

Examples of Conflict Tangible• 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

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

Management Principles & ToolsPrinciples• 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

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

Anti-Kickback: Trial Risks & Solutions• Direct payments to investigators

• Institutional financial management

• Incentives for investigators (i.e. exotic meeting locations)• Institutional contracting

• Unbudgeted payments• Institutional financial management

• 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

UNC-CH CONFLICT OF INTEREST POLICY IS STRICTER THAN FDA

• 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

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.

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.

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

E-mail: jbryde@unc.edu

Phone: (919) 843-9953

Website: http://research.unc.edu/offices/research-compliance-program/index.htm

General Email for questions: coi@unc.edu

Websites: air.unc.edu (items created after August 24, 2012)

coi-training.unc.edu

coi.unc.edu epap.unc.edu (items created before August 24, 2012)

CLINICAL TRIAL CONTRACTSAylin Regulski, MS, JD, Associate Director, Office of Clinical Trials

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

• 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

Basic Definition

Contract

• 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!

Clinical Trial Contracts

Agreements Associated with Clinical Trials

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

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

CTA

Reviewing and Negotiating CTAs

• OCT, under the Vice Chancellor for Research, provides review and negotiation, if necessary, for CTAs: http://research.unc.edu/offices/clinical-trials/index.htm

• Location: –720 Martin Luther King Jr. Blvd, Suite 100, CB# 1651–General phone: 919-843-2698

• Associate Director:–Aylin Regulski MS, JD, aylin@unc.edu

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 clinicaltrials.gov, study termination, recordkeeping

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

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)

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!

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

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

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!

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

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)

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– Clinicaltrials.gov

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

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

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

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)

CTA Content—Subject Injury

Medicare Secondary Payor (MSP) Reporting Requirements

• Medicare Reporting:— Medicare Secondary Payer (MSP): Mandatory reporting provisions of 2007

MMSEA statute make Medicare secondary to certain other types of insurance— Center for Medicare & Medicaid Services (CMS) alert: Issued May 2010

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

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

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)

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

Don’t Forget…

• READ THE CONTRACT before signing!

Call OCT if you have questions!

Aylin Regulski, Associate Director OCTaylin@unc.edu

843-7894

TRIAL REGISTRATION AT CLINICALTRIALS.GOV: FDA AND ICMJEMonica Coudurier

Office of Clinical Trials

What is ClinicalTrials.gov?• 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 ClinicalTrials.gov 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

The International Committee of Medical Journal Editors (ICMJE) PolicyPer 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.

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.

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)

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 IDE

• Industry initiated/sponsored trial – Industry sponsor registers

If 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 843-2333 or m_coudurier@unc.edu

• Amy Franklin (TraCS) at 843-9514 for LCCC/Oncology studies

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

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

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 110-85, Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and new 21 U.S.C. 331(jj).

INVESTIGATIONAL DRUG SERVICE (IDS)Sue Pope, Manager, UNC IDS

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

IDS StaffLEADERSHIP• Sue Pope, RPh

Manager, Investigational Drug ServiceEmail: spope@unch.unc.edu; Pager: 216-2450, Office: 843-9919

• Scott Savage, PharmD, MS

Assistant Director of Ambulatory Care

Email: ssavage@unch.unc.edu, Pager: 347-0622

PHARMACISTS• Linda Manor, RPh - Pharmacist

Email: lmanor@unch.unc.edu• Dave Stines, PharmD, MS -

PharmacistEmail: dstines@unch.unc.edu

• Amelia Stokely, RPh - PharmacistEmail: astokely@unch.unc.edu

GENERAL CONTACT INFORMATION• 3W IDS (Memorial Hospital)

• Fax number for orders: 966-6359• NS IDS (Neurosciences Hospital)

• Fax number for orders: 966-8735

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 919-216-9727 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

Investigational Drug Service

Memorial Hospital, 3rd Floor•919-966-6359 (fax for orders)•Prepares medications for protocols that contain chemotherapy agents or IV products

Neurosciences Hospital, Ground Floor•919-966-8735 (fax for orders)•Prepares medications for protocols that only contain oral, non-chemotherapy medications

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:1. Administration of the agent is part of protocol which requires

IRB approval

2. 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)

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 Service3rd Floor Main HospitalDepartment of PharmacyCB 7600

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.

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

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

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 966-1766 or 966-3469 or 966-3213 (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

To whom and where can Clinical Trial Materials (CTM) be sent?

• After contacting IDS (966-1766) 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 N3122101 Manning Drive

Chapel Hill, NC 27514Phone:  919-966-2987

Fax: 919-966-6359

How are Investigational Medications Dispensed?

IDS can begin preparing an investigational medication foryour patient ONLY when:

1. Completed protocol orders are faxed to 3W IDS or NS IDS Pharmacy

2. Orders must be signed by provider listed on 1572 and IRB application (original signature, not a copy)

3. Coordinator must give IDS verbal confirmation that patient is available for treatment (if pertinent to protocol)

4. Coordinators must present an original signed prescription order when picking up an investigational medication in the IDS pharmacy.

UNC INVESTIGATIONAL DEVICE POLICYAylin Regulski, MS, JD, Associate Director, Office of Clinical Trials

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:http://intranet.unchealthcare.org/policies/unc-hcs-policies-pdf-new-format/ADMIN0207.pdf

• Administrative Procedures• Device Receipt• Device Storage• Device Use/Dispensing• Device Return

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.

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.

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