BUGSDM Center for Clinical Research

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 Research
BUGSDM
January , 2012
11-12 am
Evans 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/generalclinical-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 [email protected]
– In Salud with confirmation
Potential collaborations
•
•
•
•
Project management - [email protected]
Data collection tools – [email protected]
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)
License
Salud training
HIPAA training
Appropriate clinic attire
(scrubs, blue gowns,
Read infection control
white lab coats)
manual
Online infection control On file in CCR
(electronically):
and safety training
Protocol
CPR
Current IRB approval
Human subjects training
Consent forms
(BU)
CTSI 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 training
IBC approval
ROHC 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” 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 OSHAInfection 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.
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.