Center for Clinical Research 2016 Boston University Henry M. Goldman School of Dental Medicine

1. Center for Clinical Research 2016Boston University Henry M. Goldman School of Dental Medicine Updated June 28, 2016

2. Vision: Provide global leadership in translating biomedical discoveries to improve oral and systemic health. Mission: Promote collaboration between basic and clinical scientists to translate research findings from the bench to chair-side; foster critical thinking and lifelong learning.

3. What can we do for investigators? • Help YOU conduct clinical research • Connect you with people who can answer questions • Guide you through the processes of: • Study design • IRB submission • Data forms development and management • Analyses planning • Understanding your data • Reporting your results BUGSDM Center for Clinical Research

4. Table of Contents • Staff and investigators – p. 5 • Standard operating procedures for use of the Center – pp. 6-7 • Investigator checklist – p. 8 • Hazardous materials checklist – p. 9 • HIPAA training instructions – p. 10 • Infection control training instructions – p. 11 • Codes / templates for recording visits – p.12-13 • Auditing of protocols – p. 14 GSDM Center for Clinical Research

5. CCR staff / investigator directory • Judith Jones-Director G432c, 617-414-1065, judjones@bu.edu • Kendrick Smaellie-Program Assistant G601, ksmaelli@bu.edu • Carol Nicholson-Coordinator G1, 617-638-4554, carolnic@bu.edu • Office of Associate Dean for Research • Sarahanne Sohm– Grants Manager, IRB Development • 650 Albany Street, X-Bldg, Room 344A • T: 617.638.4707 | F: 617.638.4974 • E: sasohm@bu.edu • http://www.bu.edu/dental-research • Available for consultation • Carolyn Wehler – Project management – 781-687-2856cwehler@bu.edu • Sharron Rich – Data entry tools, data entry, cleaning, management and analyses– 617-414-1232sharronr@bu.edu GSDM Center for Clinical Research

6. Standard operating procedures • On file in CRC prior to data collection: • Protocol • Current IRB approval • Consent forms □ print, scan and enter in Salud and keep on file • CTSI application form http://ctsi.bu.edu/index.php/research-resources/general-clinical-research-unit-gcru/gcru-application/. • Race and ethnicity, education now in Salud GSDM Center for Clinical Research

7. SOP, continued • Evidence of: • Human subjects training completed • Infection prevention protocols • Manual reviewed and online training completed • http://www.bu.edu/dental/files/2011/09/infection_control_manual_oct_24_2012_FINAL.pdfRequired attire and unit preparation / cleaning • CPR Training • Scheduling - by Carol Nicholson carolnic@bu.edu • In Salud with confirmation • !Research records-stored/locked in CCR or on password protected, HIPAA compliant servers! GSDM Center for Clinical Research

8. CCR Investigator checklist (updated8/27/15) • Dental license • HIPAA training • Read infection control manual • Online infection control and safety training • CPR • Human subjects training (BU or CITI) • OEM compliance • 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 training GSDM Center for Clinical Research

9. CCR Investigator checklist for studies with Hazardous Materials (updated 8/27/15) Definition: any projects that involve use of or potential exposures to what are defined as ‘hazardous materials’ (including biologic materials e.g. saliva, GCF, plaque, blood, etc.) must have: • IBC training • IBC approval • ROHC compliance • http://www.bu.edu/orccommittees/ibc/training/ GSDM Center for Clinical Research

10. HIPAA training is mandated by federal law.   All staff, students, residents and all faculty members, (including volunteer faculty, faculty with dual appointments in other BU schools and colleges, and non-BU schools and colleges, adjunct faculty, visiting faculty, etc.) must complete the Boston University online HIPAA Privacy and Security Training and the Infection Control, Safety, and Management of Medical Emergencies Training annually. HIPAA training at BUMC MUST be taken EVERY academic year in September. This applies to all new hires AND new students who took HIPAA training in July and August. HIPAA training link, along with the instructions: HIPAA Privacy and Security Training 1. Go to www.bu.edu/link 2. Click on “Document ESignature” 3. Log in using your BU Login Name and your Kerberos Password 4. Click on “HIPAA Security and Privacy Training” 5. Follow the posted directions 6. Complete “Step 4” and click on “I certify” – reenter your BU Login Name and Kerberos Password 7. An e mail will be sent confirming that you have completed the training 8. Print a copy of the confirmation for your own records. GSDM Center for Clinical Research

11. Infection Control, Safety, and Management of Medical Emergencies Training • Infection Control, Safety, and Management of Medical Emergencies Training • Access from a school-based computer, go to https://dent-sps.bumc.bu.edu/portal • Access from a home-based computer, go to http://work2.bumc.bu.edu to access the VPN client. Then go to https://dent-sps.bumc.bu.edu/portal • On the next screen click on “enter” to access the “Web Login” page • Enter your B.U. Login Name and Kerberos Password, then click on the “login” • On the next page place the pointer on the “training” tab and click on the “OSHA-Infection Control” button that appears on the drop-down menu • Select from two possible choices on the next page: • BUGSDM online IC EH S MED EMR Training (Power Point – PPT) format • BUGSDM online IC EH S MED EMR Training (PDF) format • A slide presentation will open. Please review each slide • At the conclusion of the presentation return to the first 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. • Print a copy of the Thank You confirmation for your own records. GSDM Center for Clinical Research

12. Salud notes and codes • For every Clinical Research participant in the entire School we need a note stating: • The date entered into the study • IRB Number and Title of Project • Date consent was signed • Copy of consent signed in Salud • Medical History in Salud GSDM Center for Clinical Research

13. Codes for clinic visits • Procedure Codes: • CCR01 – Research Admittance • CCR02 – Research Visit • CCR03 – Research Withdrawal • CCR04 – Research Conclusion • Sample CCR01 Note: • IRB # • Project Name • Expected date of enrollment • Date of Consent • And an area for free text GSDM Center for Clinical Research

14. Audits of protocols: SAMPLE • Note 2: HIPAA pathways include: • Preparatory to Research • Authorization • Waiver • Decedents • Deidentification • Limited Data Set Note 1: IF any of the Boxes are non-compliant The entire study is non-compliant GSDM Center for Clinical Research