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Research Coordinators Quarterly Meeting

March 7, 2017

Agenda

IRB Updates –Jenny Kucera Recruitment through the COT –Tim Widman  Investigational Pharmacy Introduction‐ Jon  Beck & 

Erin Iselin Scheduled and Unexpected Downtime on EPIC‐

Courtney Kennedy Documentation  in EPIC for Research–Courtney 

Kennedy Nebraska Medicine Compliance – Grace Videtich & 

Kristi Kiviniemi

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IRB UpdatesJenny Kucera, MS, CIPIRB Administrator/Education Coordinator

Today’s Agenda

• Changes in requirements for CITI training

• Changes to the “Common Rule”

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Changes in Requirements for CITI training

• As of January 1, 2017, NIH requires that all clinical trial staff on NIH-funded clinical trials have GCP training.

• Good news?

• UNMC implemented GCP training for everyone listed on clinical trials involving drugs and devices in May, 2014

• Majority of effected individuals have already taken it.

Changes in Requirements for CITI trainingThe other “good” news?• More people get more training!

• All currently NIH-funded active clinical trial staff that had not completed it have been notified

• Deadline for completion: May 1, 2017

• What happens if those people don’t get it done by May 1, 2017?

• PI: Study suspended

• All other staff: Removed from study personnel

• All personnel listed on an IRB application that is considered a “clinical trial” as defined by the NIH (regardless of funding)

• If individuals are identified during IRB review process, GCP training will be required before approval

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Changes in the “Common Rule”• “Common Rule” = Protection of Human Subjects Regulations

agreed upon by 16 Federal agencies

• Issued: January 19, 2017

• Effective: January 19, 2018 (except for the mandated single IRB review, which is January 20, 2020)

• On January 20, 2017, new federal administration placed a regulatory freeze pending review on regulations published, but not taken effect.

• Final rule can be implemented as is, modifications can be made or it can be scrapped.

• With uncertainty of the future of the Final Rule, limited action has been made on an institutional level.

• If it goes into effect, changes to policies, procedures and processes will be communicated and training scheduled accordingly.

Contacting Opted-in Patients Process and Procedures

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What is “opting-in”?• In 2016, the Conditions of Treatment Form was released to include the

option to be contacted for research• “Do you agree to let us contact you about potential research

studies that you may be eligible for?”• Patients can opt-out at any time for any reason either at their next

visit or over the phone with Patient Access Services• As of 1/18/17

• 45,670 have opted-in• 25,316 have opted-out

How does it work?1. The requestor submits the COT Database Recruitment Request Form to

Dr. Kratochvil for initial approval.

2. The “Request for Electronic Health Data Form” is filled out to gain an initial patient feasibility assessment https://unmcredcap.unmc.edu/redcap/surveys/?s=9TsTE2UGsM

3. The approved/signed form must be included with the IRB application

4. The IRB approval letter is sent to Purnima in order to provide the requested patient information.

– The list must be kept on a secure UNMC/NM computer and must be deleted/destroyed once it is no longer in use.

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COT Database Recruitment Request Form 

Name of Study: 

Principle Investigator: 

IRB number (if applicable):  

Purpose of Study:  

 

 

Number of Patients Needed:                     Recruitment period:                           to 

Patient Demographics/Disease (ICD code, gender, age, medication required, inclusion, exclusion):  

 

 

Patient Feasibility: 

 

How do you plan on utilizing the information?: 

 

 

 

Date Requested:      

Approved: Y/N 

  If no, reason why: 

 

Approver’s signature: 

 

 

Please return document to Tim Widman (twidman@nebraskamed.com) 

Call 9‐8587 with any questions or concerns 

Phone GuidelinesThere should be no more than 3 direct contact attempts made between all media channels (phone, mail, e-mail, etc). For example, if you send 1 letter, you may not make more than 2 calls thereafter.

Phone only: If patient does not answer on first call, do not leave a voicemail and try again after a minimum of 6 hours. If patient still does not answer, leave voicemail if applicable. If no return call after 72 hours, call again and leave a reminder voicemail. Do not call thereafter unless otherwise approved.

– If no voicemail, call once, then after 48 hours, and lastly after 72 hours.

The voicemail will not give description of the trial and any information given over the phone must ONLY be given directly to the specified patient.

Recorded Messages/Text Messaging:Recorded voice messages must use One Call Now.Text messaging can be used for reminders, thank you messages, etc. and can be done through One Chart or One Call Now.All recorded messages and text messages must follow the Telephone Consumer Protection Act

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Mail GuidelinesFirst Class Mail: • All materials should be in a sealed envelope with only patient’s name and

address and general return address.• If postcard format is appropriate, the postcard must fold and seal to cover

any medical/trial information.

E-mail: • All e-mail communications must go through Constant Contact.• E-mail designs that do not use the set forth template must be designed by

marketing and may incur an additional charge.

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Phone/Voicemail ScriptsPhone ScriptCan I please speak with Mr./Ms.___________?If patient is not available or busy, ask for a good time to call back or leave your name and call back number.If patient answers, proceed to the following script:Hello Mr./Ms._________, my name is _________ from the University of Nebraska Medical Center/Nebraska Medicine. You agreed to let us contact you about potential research studies and we have found that you may be eligible for a study that is looking at (insert one-line description). Would you be interested in learning more about this study?If yes, give a brief explanation of the study, purpose, and consenting process.If no, ask them if it is okay to call them in the future if we find out they may be eligible for a different study. If they answer yes, thank them for their time. If they decline, inform them that you will transfer the patient to Patient Access Services in order to remove their name. Transfer the call to 2-3251 (only voicemail available on weekends) and email Deb Meyer the patients name and MRN # to dmeyerk@unmc.edu for documentation purposes.

– If the patient is generally irate or says we violated a HIPPA rule, please include that in the e-mail as well as your call back number. Deb will notify the compliance team and they may contact you for additional information.

Voicemail ScriptHello Mr./Mrs. _______________, my name is __________________ from the University of Nebraska Medical Center/Nebraska Medicine. I am calling you today about a research study for which you may be eligible. If you would like to learn more, please call _______, otherwise, we will attempt to contact you one additional time. Thank you for your time.

Training Study PersonnelAll study personnel are required to review the “Opt-in Training Sheet”. This covers:• Properly maintaining the list• Using the approved scripts and tracking contacts• How to opt patients out• Guidelines for phone calls, mail, email, and recorded/text messaging

The study personnel signs this form acknowledging that they have received the SOP, understand it, and agree to follow it.

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Social Media GuidelinesGuidelines for social media usage for clinical trials have been developed. This seeks to:• Streamline the process for all parties involved• Increase the effectiveness of the post• Track results from posts

Any requests to use social media should be referred to me prior to approving content.

Investigational Drug ServiceJon Beck, Pharm.D.- Research Pharmacist Coordinatorjbeck@nebraskamed.comOffice: 402-559-5255Pager:402-888-3418

Erin Iselin, Pharm.D.-Research Pharmacisteiselin@nebraskamed.comOffice:402-559-1665Pager:402-888-1734

Heather Kloppenborg, B.S.A.,CPhT-Research Technicianhkloppenborg@nebraskamed.comOffice:402-559-1666

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Objectives• Budgeting• IRB/P&T required documents• New Protocol Checklist• Medication Orders• Policy Review

Budgeting for Pharmacy Services

• Each study varies in need and complexity

• IDS receives compensation for these services

• IDS compensation needs to be added to every budget contract

• Please consider when & where your patients will be treated. Delegated, trained staff are not available 24/7

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IRB Site & P&T Review• It is essential that all documents be uploaded to the

IRB RSS website for P&T review. These include:-IRB Application-Protocol-Consents-P&T Form (Section 2, #13 check box)-Investigator Brochure

• If you are using a Central IRB (CIRB) all documents still need to be present on the IRB RSS website for access by P&T Reviewers.

• If documents are not there for the reviewer, it will not be reviewed until all documents are present.

If you have any questions regarding P&T review or the process, please contact us.

New Protocol ChecklistREGULATORY

IDS fee ( start-up, storage fees, dispense fees) or

IDS approved fee waiver

Notify IDS for Prequalification and SIV

appointments

SIV meeting requires DOA, Training logs, etc.

P&T IRB submission with Investigational med or

organizational review committees (SRC, IBC, etc.)

IWRS/IVRS information and passwords received

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New Protocol ChecklistEPIC OrderSet/SmartSet submitted OrderSet/SmartSet approved and in Epic WBS released Training in Epic if needed

Study Team Training complete Education for all healthcare professionals

involved (if applicable) Date of first patient visit scheduled with study

team and IDS pharmacy

Medication Management MM01

Medication Management Policy MM01 states that the following patient specific information will be readily accessible to all of those involved in medication management:

age gender (sex) current medications indication for procedure, admitting diagnosis and

relevant problem list relevant laboratory values allergies/sensitivities/reactions

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Medical Staff Policy MS22Medical Staff Policy MS22 outlines what the contents of the medical record should include.

1. Electronic orders are required for requesting treatment and services

2. Types of orders may include:a. Admission, discharge, and transfer orders including medication

reconciliationb. Orders for tests and servicesc. Medication orders d. Consultation orderse. Nursing and care orders

Medical Staff Policy MS09Per Medical Staff Policy, an order is required to request and dispense medication. In policy MS09, it states that a complete medication order shall contain but is not limited to:a. Patient nameb. Date and timec. Patient weight d. Drug name e. Dose & quantityf. Dosage unitsg. Diluent if requesting other than the standard 5% D5W or 0.9% NaCLh. Dosage Form/Route of Administrationi. Frequency or interval (Frequency/interval ranges are NOT permitted (e.g. q2-4h)k. Authentication (electronic signature)

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Medication Orders

Additional directions to consider adding to orders:

• Quantity to dispense

• Directions for infusion- i.e.To run over 60 minutes

• Titrate or taper instructions

Medication Orders

• Each investigational medication has an entry in EPIC• Linked to the IRB number• SmartSets- Yolanda Jimenez (non-oncology)• Treatment Plans- Jill Kestel (oncology)

• Orders require a digital signature in One Chart or a physical signature on the order (Oncology does both)

• Orders may be pended for a later time and then signed in One Chart

• Research Assistants must pend orders

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Medication Orders• Reminders

• A printed prescription must be generated and presented to the outpatient pharmacyor IDS Pharmacist along with IWRS drug assignment, if applicable, to receive medication for an outpatient

• An order must be entered in EPIC for all inpatients or patients receiving infusions in specialty areas

OneChart investigational orders are NEVER sent electronically (e-scribed) to the outpatient pharmacy. A printed hardcopy must be provided.

Following Policy and Promoting Patient Safety Electronic medication orders create and

accurate medication history and allow all healthcare providers precise and specific direction (Continuity of Care)

A detailed order allows IDS Pharmacist to safely prepare and dispense medication.

Allows the nurse/coordinator guidance for medication administration.

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One Chart ResearchCourtney KennedyClinical Research Advisor

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Compliance Corner

Compliance CornerHow can we help You?

Grace L. Videtich, BSCompliance Sr. Analystgrvidetich@nebraskamed.com559‐7421

Kristy Kiviniemi, BS, RNInternal Audit & Compliance Monitoring, Managerkkiviniemi@nebraskamed.com559‐3774