Vision: Global leaders in testing biomedical discoveries that improve

health and quality of life

Mission: Create and disseminate new knowledge, develop and use innovative

technologies and therapeutics, and promote critical thinking and lifelong

learning.

Center for Clinical ResearchBUGSDM

January , 201211-12 amEvans 4

Agenda

• Introduction of staff and investigators• Standard operating procedures for use of the

Center• Potential collaborators

– Project management– Data collection tools– Data collection and management

• Current projects -1 minute descriptions

Center for Clinical Research• Judith Jones - Director• Carol Nicholson – Coordinator• ADR / Health Policy / HSR / General Dentistry

• Carolyn Wehler – Project management, GD• Sharron Rich – Data entry tools and data cleaning,

entry and management, HP/HSR, GD• Barbara Pyke – Operations Manager• Kristina Roman - Administrative Assistant, ADR• Erin Johnstone – Grants Manager, ADR

• Investigators - Around the table

Standard operating procedures

• On file in CRC prior to data collection:– Protocol– Current IRB approval-we will monitor monthly– Consent forms-to print, scan and put in Salud and have on

file– CTSI application form

http://ctsi.bu.edu/index.php/research-resources/general-clinical-research-unit-gcru/gcru-application/.

• Race and ethnicity, education in Salud• Patient pool – upon registration, identify patients who

would be amendable to being contacted

SOP, continued• Human subjects training completed• Infection prevention protocols-

– Manual reviewed and online training completed• https://gsdm.bumc.bu.edu/portal/cgi-bin/scenario_2.cgi

– Required attire and unit preparation / cleaning

• CPR – completed• Supplies – in locked cabinets – bring what you need

or be explicit about what you require• Scheduling - by Carol Nicholson carolnic@bu.edu

– In Salud with confirmation

Potential collaborations

• Project management - cwehler@bu.edu• Data collection tools – sharronr@bu.edu• Data collection and management –Sharron• Junior investigators – all senior investigators

will be asked to serve in some capacity

Current projects

• Drs. Sahin-Toth and Liu, Jurasic and Wehler• Dr. Oppenheim • Dr. Helmerhorst and Na Tien• Dr. Trackman• Dr. Ayilavarapu• Dr. Wu• Dr. Giordano

CCR Investigator checklist (1/2012)

LicenseHIPAA trainingRead infection control

manualOnline infection control

and safety trainingCPRHuman subjects training

(BU)

Salud trainingAppropriate clinic attire

(scrubs, blue gowns, white lab coats)

On file in CCR (electronically):ProtocolCurrent IRB approvalConsent formsCTSI application form

CCR Investigator checklist cont. (updated 2/8/2012)

• Research projects that involve use of or potential exposures to what are defined as ‘hazardous materials’ (including various biologic materials such as saliva, GCF, plaque, blood, etc.)

IBC trainingIBC approvalROHC compliance

Here’s the HIPAA training link, along with the instructions:    Go to www.bu.edu/link    Click on “Document ESignature”    Log in using your BU login name and Kerberos Password    Click on “HIPAA Security and Privacy Training”    Follow the posted directions As you complete the training program be certain to complete “Step 4” where you click on “I certify” and re-enter your BU login name and Kerberos Password. This step ensures that your name will be electronically posted on the list of people who have completed the training. Shortly after finishing this last step you will be sent an email confirming that the system recognizes that you have completed the training. Please print the confirmation message and retain it for your records because errors in computer systems occasionally happen and your printed confirmation is your insurance policy.

IMPORTANT – At the conclusion of the presentation return to the registration page by pressing the X box in the upper right hand corner of the final screen. In the last line on that page click on here to electronically certify that you have completed the training module. Although OCS will receive notification that you have completed the training and the date, please print a copy of the “Thank You” message for your own records.

And here’s the link for Infection Control, along with the instructions:       1A.     From a school computer, go to   http://gsdm.bumc.bu.edu/portal      1B.     From a home-based computer, go to   http://work2.bumc.bu.edu  to access the VPN client                Next, go to  http://gsdm.bumc.bu.edu/portal  On the next screen click on enter to access the “Web  Login” pageenter your B.U. Login Name and you Kerberos Password, then click on the login buttonon the next page place the pointer on the training tab and then click on the OSHA-Infection Control button appearing on the pull-down menuYou must select from four choices on the next page:Clinical Personnel in PPT (Power Point) formatClinical Personnel in PDF formatNon-Clinical Personnel in PPT (Power Point) formatNon-Clinical Personnel in PDF format  Select the appropriate choice for you and click on itThe system will open a slide presentation. You should take the time to review each slide carefully. REMEMBER – this information is for the safety of your  patients and colleagues and for your own personal safety as well.  

IMPORTANT – At the conclusion of the presentation return to the registration page by pressing the X box in the upper right hand corner of the final screen. In the last line on that page click on here to electronically certify that you have completed the training module. Although OCS will receive notification that you have completed the training and the date, please print a copy of the “Thank You” message for your own records.