Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan...

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Transcript of Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan...

Page 1: Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan Budget Memo Memo dated August 12, 2014 sent to the Research Department Leadership as a

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Page 2: Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan Budget Memo Memo dated August 12, 2014 sent to the Research Department Leadership as a

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GrantsRegina Tan

Budget Memo Memo dated August 12, 2014 sent to the Research Department Leadership as

a reminder that FH Research Services requires a FULL grant budget to be included in all research grant proposal applications.

A Budget Preparation Guide details certain direct costs that should be kept in mind in preparing a budget. Budget must reasonably reflect FH scope of work.

Any application which includes cost sharing1, whether mandatory or voluntary, must include a Cost Sharing Approval Form signed by the Department Administrator/Director committing the funds and by Research Services. 1 Cost Sharing is the financial support contributed by FH to externally funded

projects.

Invoicing In an effort to have a consistent way of invoicing as it pertains to Grants,

Research Services will work with the Research Departments, Research Finance, and Research Accounting to centralize this function.

Grants Team

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Grants AdministrationDepartment/Institute/Centers Pre-Award Post-Award

(Non-Financial)Post-Award(Financial)

Cancer Research & Development Stephanie Dickstein Stephanie Dickstein Sasha CogginsCardiovascular Regina Tan Regina Tan Sasha CogginsChildren's Research Regina Tan Regina Tan Sasha CogginsEndoscopy Stephanie Dickstein Stephanie Dickstein Sasha CogginsGlobal Robotics Regina Tan Regina Tan Sasha CogginsGME Stephanie Dickstein Stephanie Dickstein Sasha CogginsNeuroscience Regina Tan Regina Tan Sasha CogginsNicholson Center Regina Tan Regina Tan Sasha CogginsNursing Leerin Shields Leerin Shields Sasha CogginsOrthopaedics Stephanie Dickstein Stephanie Dickstein Sasha CogginsSurgery/ISA Stephanie Dickstein Stephanie Dickstein Sasha CogginsThrombosis Leerin Shields Leerin Shields Sasha CogginsTransplant Leerin Shields Leerin Shields Sasha CogginsTRI-MD Leerin Shields Leerin Shields Sasha CogginsUrology Leerin Shields Leerin Shields Sasha CogginsWomen's Health (OB, GYN, Breast, and Fertility) Stephanie Dickstein Stephanie Dickstein Sasha Coggins

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IRBJanice Turchin

• Reportable New Information• Not sure if an item/issue needs reported?

• Patient missed appointment • Safety Reports• Adverse events

• Important to involve PI• PI responsibilities – PI Forum

• Moving forward • New Forms Review• Engaging PI’s

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Educational activity – to include CME’s

Mandatory for all investigators (regardless of credentials)

Working on dates/locations for January 2015

Anticipate one (1) hour including time allotted for Q/A

Post-session (immediately following Forum) available for those who want to learn more – Non-obligatory

RSVP required / IRB soliciting contact information

Investigator Forum Coming Soon

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ORAMichelle Dolske

• New Processes• Case Study – BIG CHANGE

• Now defined as 1, 2, or 3 cases• Must be submitted to ORA prior to submitting to external

entity• Scholarly Work – NEW SERVICE• De-identified Data Sets – NEW SERVICE

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Case Studies

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Researcher submits Reviews Prep

to Research Request to IRB

Researcher identifies

cases from his/her

clinical work (and

obtains Authorization

from patient, if

possible)

Researcher needs to

identify cases from

medical record search

Researcher would like to write a

Case Study (defined as up to 3 cases)

IRB Approves

Reviews Prep

to Research

Researcher reviews medical

records to identify cases for

inclusion

Researcher submits case study

to ORA

ORA Review

· De-identification of data or

Authorization signed by patient

· Compliant with FH P&Ps and SOPs

· If needed, contracts are in place

Researcher submits for

presentation and/or publication

ORA approves

case study

Researcher prepares case study

No corrections needed

Corrections or

additional

Information

needed

Case Study or Case Report: The analysis and

report of 1, 2, or 3 patients. A Case Study is generally

prepared for the purposes of illustrating some points in the

care of a patient, to educate, and/or to formulate new

research questions. A case study, by virtue of its publication

or presentation at a meeting, contributes to generalizable

knowledge, albeit at a low level of evidence. The following

types of cases may be worthy of reporting:

· Uncommon observations or practices

· Report of a new condition, treatment and follow up

· Report of a treatment not previously reported for a

known condition

· Report of atypical response to treatment

· Report of a familial condition with a proposed mode of

inheritance

· A new theory

· Questions regarding a new theory

· Unusual combination of conditions or events that cause

confusion

· Adverse responses to therapies

· Personal Impact

· Unique aspects of practice not previously reported

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ScholarlyWork

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Researcher submits Reviews Prep

to Research Request to IRB

Researcher identifies

cases from his/her

clinical work (and

obtains Authorization

from patient, if

possible)

Researcher needs to

identify cases from

medical record search

Researcher would like to write a

Scholarly Work (such as book chapter) that includes patient information

IRB Approves

Reviews Prep

to Research

Researcher reviews medical

records to identify cases for

inclusion in scholarly work

Researcher submits scholarly

work to ORA

ORA Review

· De-identification of data or

Authorization signed by patient

· Compliant with FH P&Ps and SOPs

· If needed, contracts are in place

Researcher submits for

presentation and/or publication

ORA certifies scholarly

work is HIPAA compliant

Researcher prepares scholarly

work

No corrections needed

Corrections or

additional

Information

needed

Scholarly Activity Requiring Review: Demonstration of scholarship can be established with many

activities. Only activities that include patient information or

images require review. Examples include:

· Writing book chapters or articles

· Presentation at seminars, workshops, or educational

conferences

· Platform or poster presentation at national and

regional meetings

· Platform or poster presentation of clinical topics at

educational conferences and programs

· Community seminars

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De-identifiedData Set

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Researcher is obtaining de-identified

data set from Florida Hospital

Researcher would like to use a

de-identified data set for a

research study.

Researcher would like to conduct a

Research Study using a

De-identified Data Set

Data set is provided

by an entity that

requires a Data Use

Agreement (DUA)

Researcher is obtaining de-identified

data set outside of Florida Hospital.

Researcher identifies who is creating

data set (cannot be researcher).

Data set is sent to the ORA

Data set is

provided by an

entity that does

not require a DUA

ORA biostatistician or designee reviews

data set. The Expert Determination

Method or the Safe Harbor Method are

used to satisfy the HIPAA Privacy Rule’s

de-identification standard.

ORA certifies data set

meets HIPAA de-identification

standard

Data set is sent to

researcher to begin study

Researcher works

with ORA to obtain

DUA

Information or

decision-making

needed from

Researcher

No additional

information

needed

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Dr. Rodricks

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RESEARCH POSTER PRESENTATION DESIGN © 2012

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This PowerPoint 2007 template produces a 30”x40” presentation poster. You can use it to create

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We provide a series of online tutorials that will guide you through the poster design process and

answer your poster production questions. To view our template tutorials, go online to

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QU ICK START

Zoom in and out As you work on your poster zoom in and out to the level that is more comfortable to you. Go

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Title, Authors, and Affiliations Start designing your poster by adding the title, the names of the authors, and the affiliated institutions. You can

type or paste text into the provided boxes. The template will automatically adjust the size of your text to fit

the title box. You can manually override this feature and change the size of your text.

TIP: The font size of your title should be bigger than your name(s) and institution name(s).

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your desktop, copy and paste or by going to INSERT > PICTURES. Logos taken from web sites are likely to be low

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TIP: See if your school’s logo is available on our free poster templates page.

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PICTURES. Resize images proportionally by holding down the SHIFT key and dragging one of the corner handles.

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Image Quality Check Zoom in and look at your images at 100% magnification. If they look good they will print well.

ORIGINAL DISTORTED Corner handles

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the color theme of your choice. You can also create your own color theme.

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working on the master be sure to go to VIEW > NORMAL to continue working on your poster.

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The default template text offers a good starting point. Follow the conference requirements.

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click on TABLE. A drop-down box will help you select rows and columns.

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be re-formatted by RIGHT-CLICK > FORMAT SHAPE, TEXT BOX, Margins.

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Florida Hospital is ranked the #1 hospital in the state of Florida and #26 nationally for Neurology and Neurosurgery by U.S.

News & World Report for 2014-15. It is also the number one hospital nationally for Neurology volume with greater than 10,000

inpatient visits in 2013. In November 2010, our hospital changed the Neurocritical Care (NCC) staffing to a partially closed

model, which required patients to be managed by an intensivist. Previously, the intensivist management was optional. Few

studies have examined the effect of an intensivist in an NCC unit1,2,3. The purpose of this study was to identify both patient and

economic benefits of a new requirement for mandatory intensivist management upon admittance into the NCC unit.

Primary Objective: To show that mandatory intensivist management in an NCC unit decreases NCC length of stay (LOS). This

was accomplished by retrospectively comparing LOS for patients admitted into the NCC unit during the 12 months before and

the 12 months after the new staffing model.

Secondary Objectives: 1) To show that mandatory intensivist management maintains excellent patient outcomes and benefits

the community by decreasing service line closure rates. This was accomplished by comparing Acute Physiology and Chronic

Health Evaluation III (APACHE III) scores, the emergency transfer center (ETC) decline rates, mortality and discharge disposition

during the two time periods. 2) To show that mandatory intensivist management has a positive economic benefit through

decreased resource utilization.

Background

Methods

Results Continued

Implementation of mandatory intensivist management in the NCC unit statistically improved NCC length of stay. This

improvement was maintained throughout the entire hospital stay. The percentage of patients that were declined for NCC

admission due to a closed service line decreased significantly. With improved resource utilization an increased number of

patients were able to be treated, which has significant benefits to the community. There were no statistically significant

differences in mortality, APACHE III Scores or discharge disposition. This data supports the implementation of mandatory

intensivist management in an NCC unit.

References 1. Knopf, L., Staff, I., Gomes, J., McCullough, L. Impact of a Neurointensivist on Outcomes in Critically Ill Stroke Patients. Neurocrit Care 2012; 16:63-71.

2. Josephson, S.A., Douglas, V. C., Lawton, M.T., English, J.D. Smith, W. S., Ko, N. U. Improvement in intensive care unit outcomes in patients with subarachnoid hemorrhage after initiation of

neurointensivist co-management. J. Neurosurg 2010; 112:626-630.

3. Varelas, P. N., Eastwood, D., Yun, H. J., Spanaki, M. V., Bey, L. H., Kessaris, C., Gennarelli, T. A. Impact of a neurointensivist on outcomes in patients with head trauma treated in a

neurosciences intensive care unit. J Neurosurg 2006; 104:713-719.

Results

Special thanks to

• Dr. Julie Pepe, Biostatistician, FH Office of Research Administration

• The APACHE team especially, Cheryl Williams, Critical Care Services & Tess Mendoza, Outcomes Coordinator

• The Financial Services Team especially, Rossitza Kassabova, Finance Director, FH Orlando Cardiovascular &

Neuroscience SBUs & Amy Montevilla, Financial Analyst, FH PFS

A retrospective review comparing 1,551 patients admitted to the NCC unit from November 1, 2009-October 31, 2010 with 1,702

patients admitted from January 1, 2011-December 31, 2011 was performed. This included examining LOS, APACHE III scores,

service line decline rates for the unit, mortality and discharge disposition. The percentage of patients managed by an intensivist

during each of the two time periods was analyzed based off of the Patient Financial Services (PFS) database. The secondary

objective data was in summary form, except for financial values. Summary measures, such as mortality and ETC closure rates

were obtained from monthly reports for the NCC unit. Individual financial data was collected based on direct cost and analyzed.

1Florida Hospital Orlando, Neurocritical Care, Orlando, FL, United States; 2Florida State University, College of Medicine, Orlando, FL, United States; 3Florida Hospital Orlando, Neuroscience Research Institute, Orlando, FL, United States; 4University of Central Florida, College of Medicine, Orlando, FL, United States

Rodricks, M.B.1,2, Napolitano, S. E.3, Anderson, G. A.3, Basignani, C.3,4, Tuppeny, M.1

Mandatory Intensivist Management Decreases Length of Stay and Allows for an Increase in Admissions to a Neurocritical Care Unit

Acknowledgements

Prior to the new staffing model, 51.47% of patients were managed by an intensivist. That number rose to 97.60% after

implementation of mandatory intensivist management. APACHE III scores were comparable between the two time periods,

indicating that acuity levels were unchanged. NCC LOS was reduced from 4.6 days to 3.7 days, (p<0.001). This difference was

maintained for the entire hospitalization, 9.8 days vs. 8.7, (p<0.001). The number of NCC admissions per month increased, 129

patients per month vs. 142 patients per month (p=0.017). The percentage of patients that were declined admission due to a

closed service line decreased from 12.36% to 5.66%, (p=0.020). Mortality rates remained below national predicted values and

discharge disposition remained unchanged. Direct hospital cost with an NCC stay was statistically more expensive in 2010 than

in 2011, $4146.55 vs. $3736.55 (p=0.017).

772

1709 1500

1751

0

200

400

600

800

1000

1200

1400

1600

1800

2000

Nov 2009-Oct 2010 Jan-Dec 2011

Patients Seen by anIntensivist

Total Patients4.6

3.7

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

Nov 2009-Oct 2010 Jan- Dec 2011

Average NCC LOS in Days Patients managed by an Intensivist

Limitations

Conclusion

129

142

120

125

130

135

140

145

Nov 2009-Oct 2010 Jan-Dec 2011

Average Number of Patients per Month

Based on patient consults provided by PFS; p<0.001 Based on the monthly averages provided by APACHE III Data; p<0.001

Study Limitations: Data collected was performed retrospectively and analyzed from two different sources: APACHE III and PFS.

APACHE III analyzed patients based off of admissions and PFS analyzed patients based off of discharge. Both datasets examined

the same set of patients, but there was a difference in the number of patients that were grouped in the pre-and post

categories, 1551/1702 (APACHE III) vs. 1500/1751 (PFS).

Statistical Limitations: With only 12 months in each time period for APACHE III and ETC data, analysis may be limited to visual

comparison, but non-parametric analysis may be appropriate.

12.36%

5.66%

0.00%

5.00%

10.00%

15.00%

Nov 2009-Oct 2010 Jan-Dec 2011

ETC Percent of Patients Declined

Based on the APACHE III monthly averages; p=0.017

Based on the monthly averages provided by Emergency Transfer Center; p=0.020

Contact Information

Michael Rodricks, MD

Critical Care Specialists

2501 North Orange Avenue, Suite 401

Orlando, FL 32804

[email protected]

4,161.55

3,767.55

3400

3600

3800

4000

4200

2010 2011

Direct Cost

45

43.42 42.5

4343.5

4444.5

4545.5

Nov 2009- Oct 2010 Jan-Dec 2011

APACHE III Scores

APACHE III scores were based on APACHE III monthly averages not statistically significant

Florida Hospital is ranked 26th nationally in Neurology and Neurosurgery by U.S. News & World Report.

51.47% 97.60%

Based on PFS data for each patient; p=0.017 Not adjusted for hospital LOS or for inflation

8.5 7.17

0

2

4

6

8

10

Nov 2009-Oct 2010 Jan-Dec 2011

Average Morality

Numerical difference based on APACHE III monthly averages not statistically significant

National Predicted Average

65

29.7 5.3

65.3

30.7 4

0

20

40

60

80

Good Bad Other

Discharge Disposition

Good=Home, Self-Care, Home Health Service, Rehab, Against Medical Advice Bad=SNF, Expired, Hospice, Hospice Medical Facility

Based on PFS data for each patient

Page 16: Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan Budget Memo Memo dated August 12, 2014 sent to the Research Department Leadership as a

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Research LegalViki Prescott

Improvements to policies related to Legal

• Revisions to hospital admissions documents being finalized, and similar form for ancillaries• HIPAA authorization for use of PHI and tissue for future research • Set stage for streamlined approval for use of tissue/fluids for

research• Policies and procedures related to these changes coming in a couple

of months• Date for roll-out of new patient forms soon

• Invention disclosure process coming in fall for things that may be patentable• Process: Complete Invention Disclosure online form and submit

through the site. Submitter will receive confirmation email. Review process is under development now.

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Research LegalViki Prescott

• Improvements in processes and workflow• New software tool for Legal project tracking

implemented July 22, 2014• Read access available by research department, upon

request

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Dual Enrollment Obtaining lab documents from FH lab COI Forms Recruitment of Employees IRBnet Tagging

Additional ORA Topics:

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The practice of study participants participating in more than one clinical research study simultaneously or enroll in a single clinical investigation multiple times (for example the same trial at different sites).

Dual Enrollment

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Some study subjects may not realize it is a problem unless they are specifically asked about their study participation and educated.

Others may hope to benefit from either: Increased compensation Additional healthcare

as a result of their study participation.

Why do Subjects Dual Enroll?

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“FDA strongly discourages these practices as enrollment in more than one clinical investigation could increase risks to subjects… and confound the results of the clinical investigations.”

Excerpt from “FDA Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors; Draft Guidance, July, 2014”

FDA Speaks on the Subject of Dual enrollment

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Increases risk to the subject. Potential exposure to more than one investigational

product simultaneously Safety profiles not yet well understood Potential drug or device interactions

Increases difficulty in understanding all the potential risks and proposed benefits

Increased time and demands of multiple protocols May harm the integrity of the study data and

confound study results

The Problems with Dual Enrollment

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Information Gathering Type of trial, Investigational product,

interfering study activities, length of participation

Principal Investigator Determination Is it safe for the subject to participate in both

protocols in the opinion of the PI, and could is jeopardize the results?

Documentation

Your subject answered “Yes” Now what?

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The FH Laboratory has a separate website outside of InSite: www.flhosplab.com/

All lab certification documents necessary for your regulatory binder are accessible here for all campuses

You still have to request the appropriate Lab Director’s CV as those are not included on the website.

You may request via the contact form on the website, or contact Linda Valdes via email.

Lab Certification Documents

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Recruitment of EmployeesP&P 400.120 SOP 400.120A

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Updated COI Form

Available NOW!

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IRBnetMaking the MOST out of Tags

3 Easy Steps!!!1. Develop tag schema for you or your department2. Create tags in IRBnet3. Apply tags to your departmental projects

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Step 1: Develop Tag Schema Creating and Managing Tags in IRBNet is a great

way to organize projects and be able to see what is going on with a project without clicking in packages.

Tags can be created to show a process flow from initial receipt of regulatory documents through the life of the project.

Take time to develop your tagging schema before you dive in. Get your team to brainstorm how the team currently functions and how you would like to improve functioning with the use of a robust tagging system.

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Step 1: Develop schema (continued)

Tags can be categorized to suit many needs. Examples: Delineate actions to be taken on the project Delineate pending or completed items Assign staff to tasks on a project Characterization of study (e.g., sponsor, type of study –

drug, device) Use color coding schema for “stages” of task:

Need – Dark Pink Received from sponsor – Light Pink Submitted – Light Yellow Pending – Light Green Approved – Dark Green

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Externally Sponsored --- Examples of Tags Site Feasibility form needed Site Feasibility form received Site Feasibility form submitted Site selection pending Site selected RRA needed RRA completed by dept RRA submitted without signatures RRA pending signatures RRA complete and submitted

CDA needed CDA received from sponsor CDA submitted to ORA for legal review

CDA approved and pending signatures CDA fully executed

Protocol needed Protocol received from sponsor Protocol submitted for review by MD Protocol pending acceptance by MD Protocol accepted by MD

CTA needed CTA received from sponsor CTA submitted to ORA for legal review

CTA approved and pending signatures CTA fully executed

Budget-Sponsor needed Budget-Sponsor received Budget-Sponsor under review by dept

Budget-Sponsor pending negotiation by dept Budget-Sponsor accepted by dept

Budget-ORA needed Budget-ORA completed by dept Budget-ORA submitted to ORA for review Budget-ORA under review Budget-ORA approved

1572 needed 1572 completed by dept 1572 submitted to MDs for completion 1572 pending MD signatures 1572 submitted to sponsor

Financial Disclosure needed Financial Disclosure completed by dept

Financial Disclosure submitted to MDs for completion

Financial Disclosure pending MD signatures

Financial Disclosures submitted to sponsor

IRB other documents needed from sponsor

IRB other documents received from sponsor IRB project submitted to IRB IRB project pending approval IRB approved

Consent needed Consent received from sponsor Consent modified for IRB and matching contract Consent pending sponsor approval Consent approved by sponsor

IB needed IB received from sponsor

eCRF training needed eCRF training scheduled eCRF training initiated eCRF training pending for all team members eCRF training completed

SIV needed SIV scheduled SIV pending SIV completed IP Drug needed IP Drug shipped IP Drug received IP Device needed IP Device shipped IP Device received

ORA Institutional Clearance needed ORA Institutional Clearance – all documents submitted ORA Institutional Clearance pending ORA Institutional Clearance

received Regulatory staff assigned REG – Jill REG – Mary REG – REG - CRC assigned CRC – Bob CRC – Jan CRC – Pam CRC - Sue IRB to be used IRB - FH IRB – WIRB IRB – Quorum IRB - CIRB Sponsor Sponsor Merck Sponsor GSK Sponsor Medtronic Sponsor Covidien Study Type Phase I/II Phase III Phase IV Registry Study Status Status – project in development Status – IRB/ORA approved Status – Open Status - Closed Records (study) location of… Records onsite Records Iron Mountain

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Step 2: Create Tags

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1. Type in tag name

2. Select tag color

3. Create a new tag!

1 2

3

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Step 3: Apply Tags To tag a project click on the icon next to the

Study Title.

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Step 3: Apply Tags (continued) A box will come up with Add and Remove Tags.

Once tags have been created there are 2 options for the type of Tag:

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Step 3: Apply Tags by clicking on:

Personal Tags only you can view

the tag

Shared Tags any team member

with access to the project can view the tag

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Sorting by Tags When multiple projects

appear on the “My Projects” list, it can be beneficial to sort the projects by tag.

You can sort by any tag by clicking the drop down box and selecting the tag you would like to search by.

Hit enter, and the projects with that tag will be listed.

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Modifying Tags Changing the Tag Name

Click on the Tag name and modify in the box Delete the Tag

CAUTION!!! To delete a tag simply click on the t at the right-

sided end of the row (next to the Tag Color). Once you hit “delete,” you will receive a message “Remove

from all projects and delete tag?” If you click “OK,” the tag will be removed from all projects

currently tagged with this tag

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Tag Pointers Reminder: Take time to develop your tagging schema before

you dive in. Get your team to brainstorm how the team currently functions and how you would like to improve functioning with the use of a robust tagging system.

When Creating Tags, keep the tag name short as it may be cut off from view when added to the project if the tag name is long

You can see the whole tag name by hovering over it. Remember if you Delete a Tag, it is removed from all projects

that currently have that tag in use People who have been granted access to the project can see the

tags. The IRB, ORA, and FH Grants cannot see the tags placed on projects!!

Feel free to use as many tags as you need. There is no limit! Happy Tagging!!!

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Orthopedic Research will be giving an oral presentation at the upcoming AAOS (American Academy of Orthopedic Surgeons) Conference in Las Vegas (March 2015). Patella Fracture Fixation Using a Load-Bearing Cable System.

Thrombosis Research has 2 papers accepted for publication: Peerschke, EIB, Castellone, DD, Stroobants, AK and Francis, JL.

Reference Range Determination for whole blood aggregation using the Multiplate® analyzer. American Journal of Clinical Pathology 2014 (in press).

Amirkhosravi A, Boulaftali Y, Robles-Carrillo L, Meyer T, McKenzie SE, Francis JL, Bergmeier W. CalDAG-GEFI deficiency protects mice from FcγRIIa-mediated thrombotic thrombocytopenia induced by CD40L and β2-GPI immune complexes. J Thromb Haemost. 2014 (in press).

Research Recognition

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IRB RemindersRenewals / Study Closures

Must be received well in advance of IRB Study Expiration Date 30 days per IRB letter There may be issues that need addressed before Review

Study Closures must be submitted before Study Expiration Date

Failure to do so = Non-Compliance

Sponsors contacting IRB Looking Forward – Restrictions / Continuing Non-Compliance

IRB Classes – On-Line Calendar

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Steven Smith, MDChief Scientific Officer

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Thank you for your attendance at Research Matters!

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