1. 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.

2. Center for Clinical Research BUGSDM January 20, 2012 11-12 am Evans 4

3. 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

4. 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

5. 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/. 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

6. 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.educarolnic@bu.edu – In Salud with confirmation

7. Potential collaborations Project management - cwehler@bu.educwehler@bu.edu Data collection tools – sharronr@bu.edusharronr@bu.edu Data collection and management –Sharron Junior investigators – all senior investigators will be asked to serve in some capacity

8. CCR Investigator checklist (updated2/27/2012)  License  HIPAA training  Read infection control manual  Online infection control and safety training  CPR  Human subjects training (BU)  Salud training  Appropriate clinic attire (scrubs, blue gowns, white lab coats)  On file in CCR (electronically):  Protocol  Current IRB approval  Consent forms  CTSI application form  HIPAA status

9. CCR Investigator checklist cont. (updated 3/12/2012) 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 training  IBC approval  ROHC compliance  http://www.bu.edu/orc committees/ibc/trainin g/ and http://www.bu.ed u/rohp/services/trainin g-materials/ http://www.bu.edu/orc committees/ibc/trainin g/http://www.bu.ed u/rohp/services/trainin g-materials/

10. Here’s the HIPAA training link, along with the instructions: Go to www.bu.edu/linkwww.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.

11. And here’s the link for Infection Control, along with the instructions: 1A. From a school computer, go to http://gsdm.bumc.bu.edu/portalhttp://gsdm.bumc.bu.edu/portal 1B. From a home-based computer, go to http://work2.bumc.bu.edu to access the VPN clienthttp://work2.bumc.bu.edu Next, go to http://gsdm.bumc.bu.edu/portalhttp://gsdm.bumc.bu.edu/portal On the next screen click on enter to access the “Web Login” page enter your B.U. Login Name and you Kerberos Password, then click on the login button on the next page place the pointer on the training tab and then click on the OSHA- Infection Control button appearing on the pull-down menu You must select from four choices on the next page: Clinical Personnel in PPT (Power Point) format Clinical Personnel in PDF format Non-Clinical Personnel in PPT (Power Point) format Non-Clinical Personnel in PDF format Select the appropriate choice for you and click on it The 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.

12. 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.