Center for Clinical Research Operations Manual Boston University

Center for Clinical Research Operations Manual Boston University Henry M. Goldman School of Dental Medicine Updated June 19, 2012

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.

Table of Contents • Staff and investigators – p. 4 • Standard operating procedures for use of the Center – pp. 5 -6 • Investigator checklist – p. 7 • Hazardous materials checklist – p. 8 • HIPAA training instructions – p. 9 • Infection control training instructions – p. 10 • Codes / templates for recording visits – p. 11 -12 • Auditing of protocols – p. 13 BUGSDM Center for Clinical Research 3

CCR staff / investigator directory • Judith Jones – Director – G 612 A, 617 -414 -1065, judjones@bu. edu • Carol Nicholson – Coordinator – G 107, 617 -638 -4554, carolnic@bu. edu • Office of Associate Dean for Research • Kristina Roman - Administrative Assistant – – – 650 Albany Street, X- Bldg, Room 343 Boston, MA 02118 -2393 T: 617. 414. 1028 | F: 617. 638. 4974 E: kayroman@bu. edu http: //www. bu. edu/dental-research • Erin Johnstone – Grants Manager, IRB Development – – 650 Albany Street, X-Bldg, Room 344 A T: 617. 638. 4707 | F: 617. 638. 4974 E: ejstone@bu. edu http: //www. bu. edu/dental-research • Available for consultation • Carolyn Wehler – Project management – 781 -687 -2856 cwehler@bu. edu • Sharron Rich – Data entry tools and data cleaning, entry and management – 617 -414 -1232 sharronr@bu. edu BUGSDM Center for Clinical Research 4

Standard operating procedures • On file in CRC prior to data collection: – Protocol – Current IRB approval - we will monitor monthly – Consent forms - print, scan and put in Salud and on file – CTSI application form http: //ctsi. bu. edu/index. php/researchresources/general-clinical-research-unit-gcru/gcruapplication/. • Race and ethnicity, education in Salud BUGSDM Center for Clinical Research 5

SOP, continued • Evidence of: – 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 – current • Scheduling - by Carol Nicholson carolnic@bu. edu – In Salud with confirmation • !Research records-stored in CCR until study closed! BUGSDM Center for Clinical Research 6

CCR Investigator checklist (updated 2/27/2012) q License q HIPAA training q Read infection control manual q Online infection control and safety training q CPR q Human subjects training (BU) q OEM compliance q Salud training q Appropriate clinic attire (scrubs, blue gowns, white lab coats) q On file in CCR (electronically): q. Protocol q. Current IRB approval q. Consent forms q. CTSI application form q. HIPAA training BUGSDM Center for Clinical Research 7

CCR Investigator checklist for studies with Hazardous Materials (updated 3/12/2012) • Definition: any projects that involve use of or potential exposures to what are defined as ‘hazardous materials’ (including biologic materials such as saliva, GCF, plaque, blood, etc. ) q IBC training q IBC approval q ROHC compliance q http: //www. bu. edu/orc committees/ibc/trainin g/ and q http: //www. bu. edu/roh p/services/trainingmaterials/ BUGSDM Center for Clinical Research 8

HIPAA training link Here’s the , 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” BUGSDM Center for Clinical Research 9 message for your own records.

And here’s the link for 1 A. 1 B. Infection Control, along with the instructions: From a school computer, go to http: //gsdm. bumc. bu. edu/portal From a home-based computer, go to http: //work 2. bumc. bu. edu to access the VPN client; then 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 BUGSDM Center for the Clinical Research 10 notification that you have completed the training and date, please print a copy of the “Thank You” message for your own records.

Salud notes and codes • • • For every participant we need a note stating: The date entered into the study IRB# and Title of Project Date consent was signed. Copy of consent signed in salud. Med hx in Salud. BUGSDM Center for Clinical Research 11

Codes for clinic visits • Procedure Codes: – – CCR 01 – Research Admittance CCR 02 – Research Visit CCR 03 – Research Withdrawal CCR 04 – Research Conclusion • Sample CCR 01 Note: – – – IRB # Project Name Expected date of enrollment Date of Consent And an area for free text BUGSDM Center for Clinical Research 12

Monthly Audits of protocols: SAMPLE I. R. B. expiration number date Study Name PROTOCOL HIPAA ON FILE? category expires Oral quality of life in H-2 xxxx 05/30/2012 children yes Note 1: IF any of the Boxes are noncompliant The entire study is non-compliant Start End Date 6/4/ authorized 2010 HAZMAT PI 5/30/ 2012 YES Jones License CPR Wehler/ Rich Y/Y inf contr ol IRB HIPAA Y/Y Y/Y Note 2: HIPAA pathways include: • Preparatory to Research • Authorization • Waiver • Decedents • Deidentification • Limited Data Set BUGSDM Center for Clinical Research 13