��>� '*���$%&�����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������i ��bjbj އjj&i�������HH������������8'����Ycb��A"(i"i"i"�$�i%l�%8TbVbVbVbVbVbVbf�qinVb�� &�$�$" & &Vb��i"i"c�(�(�( &F�i"�i"a��( &Tb�(�(JW�v[i"����ژG�����S&�&Y,a)c0YcRY$i�&�iXv[v[�i�L\@�( & & &VbVb�'� & & &Yc & & & &��������������������������������������������������������������������i & & & & & & & & &HY �: Qualified Principal Investigator (QPI) Research Project Team Member (RPTM) Identifying/Credentialing Process A Research Project Team Member (RPTM) must be supervised by a Toronto East Health Network (TEHN) credentialed Qualified Principal Investigator (QPI). As per the  HYPERLINK "https://ichgcp.net/" International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the  HYPERLINK "https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html" Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) the QPI has and accepts total responsibility for the conduct of their clinical research including their research team. This form must be used to credential and add a RPTM (e.g., research assistant, data abstractor, research volunteer, supervised student carrying out independent research) to an approved TEHN research project. Please submit one form for each new RPTM. Qualified Principal Investigator Responsibilities: PART 1 QPI Certifications The TEHN researcher/investigator must be a QPI in order to supervise RPTMs. The QPI must fulfill the following:  FORMCHECKBOX  TCPS 2 tutorial /  FORMCHECKBOX  TCPS 2 certificate already on file  FORMCHECKBOX  MGH Privacy Training for Research Personnel module /  FORMCHECKBOX  Privacy certificate already on file Courses available at  HYPERLINK "http://www.tehn.ca" www.tehn.ca ( Education & Research  FORMCHECKBOX  Standard Operating Procedures (SOPs) Modules 1-3 /  FORMCHECKBOX  SOP certificates already on file Course available on iLearn (if not completed notify  HYPERLINK "mailto:ResearchAdmin@tehn.ca" ResearchAdmin@tehn.ca)  FORMCHECKBOX  Read the PSHSA � HYPERLINK "https://www.pshsa.ca/wp-content/uploads/2017/06/Physicians-OHS-Roles-Responsibilities.pdf" Physicians� Occupational Health & Safety Roles and Responsibilities� document PART 2 Credential & Identify Your RPTM Collect the following certifications, completed by your RPTM, and must be submitted with this form:  FORMCHECKBOX  TCPS 2 tutorial  FORMCHECKBOX  MGH Privacy Training for Research Personnel module Available at  HYPERLINK "http://www.tehn.ca" www.tehn.ca ( Education & Research  FORMCHECKBOX  Standard Operating Procedures (SOPs) Modules 1-3 (MGH personnel only) Available on iLearn (if not completed notify  HYPERLINK "mailto:ResearchAdmin@tehn.ca" ResearchAdmin@tehn.ca) Please complete the following and provide a full description of the RPTMs research job duties and responsibilities. For roles� clarification, please see  HYPERLINK \l "_PART_4" Research Roles Definitions at the end of this form. RPTM Name: FORMTEXT      Email: FORMTEXT      Project Title: FORMTEXT       (Exactly as identified on the protocol/application)REB Reference #: FORMTEXT       (As identified on the REB approval letter; e.g., 123-1234-Aaa-123) Role of RPTM: FORMTEXT      Duties/Description: FORMTEXT       Complete ONE of the following sections only:Section #1 StudentsIs this role part of a taught course or placement?  FORMCHECKBOX  Yes  FORMCHECKBOX  No, complete section #3 NOTE: If the student is paid by MGH, please complete section #2.If YES please identify the Educational Institution & Course  FORMTEXT      Start Date of Student: FORMTEXT      End Date of Student: FORMTEXT      Section #2 Research Assistants (RA) Data Abstractors MGH Hired StudentsIs this role a paid position?  FORMCHECKBOX  Yes  FORMCHECKBOX  No, complete section #3 If YES, by whom?  FORMTEXT       (please identify the person and organization) NOTE: If this person is under contract to an MGH investigator (not the institution) you will be required to provide a copy of their Criminal Reference Check, unless they are an existing MGH employee.Is this person an existing MGH employee?  FORMCHECKBOX  Yes  FORMCHECKBOX  NoStart Date of RA: FORMTEXT      End Date of RA: FORMTEXT      Section #3 Volunteers NOTE: All research volunteers MUST BE APPROVED by the Department of Research & Innovation Has the Volunteer position been approved by the Department of Research & Innovation?  FORMCHECKBOX  Yes  FORMCHECKBOX  NoPlease identify specific days and hours (e.g., Mon-Fri; 9am-5pm)  FORMTEXT      Start Date of Volunteer: FORMTEXT      End Date of Volunteer: FORMTEXT      Section #4 Study MonitorsInclude the following with this completed form:  FORMCHECKBOX  Current CV  FORMCHECKBOX  Certifications; identify:  FORMTEXT      Expected visit date(s):  FORMTEXT      Section #5 Adjunct ResearchersAs appointed. No further documentation required. IT Requests: FORMCHECKBOX  MGH TEHN Email Address  FORMCHECKBOX  Shared Drive Permission:  FORMCHECKBOX  Full Access  FORMCHECKBOX  Read Only Access EXACT Name of shared drive:  FORMTEXT       FORMCHECKBOX  Cerner (Powerchart)  A training information brochure will be provided  FORMCHECKBOX  VPN Remote Access (assessed by the Department of Research & Innovation)  FORMCHECKBOX  Photo Identification Badge  FORMCHECKBOX  Other:  FORMTEXT      All ID Badges must be returned to the Department of Research & Innovation when the specified end date is reached. Cerner/VPN access will be terminated on the end date. If an extension beyond the end date is required, please submit a request to  HYPERLINK "mailto:ResearchAdmin@tehn.ca" ResearchAdmin@tehn.ca. PART 3 Signature The QPI is required to keep the RPTM records as part of their responsibilities in their role as a QPI. This information should be readily available upon request. I  FORMTEXT       as a MGH TEHN QPI have read, understand, and agree to the terms outlined in this document. ______________________________________________ _____________________________________________ Qualified Principal Investigator Signature Date PART 4 Submission Please send by email a scanned copy of this signed document including all certificates as outlined above. Send to:  HYPERLINK "mailto:ResearchAdmin@tehn.ca" ResearchAdmin@tehn.ca Once all documentation has been received by the Department of Research & Innovation the onboarding of your RPTM will begin. RPTMs will be directed to the relevant person/department to complete the onboarding process as identified by their confirmed role. Research Roles Definitions: Student/Resident/Fellowship (Section #1) Any individual assisting a QPI and is attending an affiliated University/College completing a research related placement. These individuals are researchers� when conducting research at MGH TEHN, and this includes research projects as part of taught courses, or research conducted as part of a placement. Research Assistant (RA) (Section #2) A research assistant is a paid position that is involved in the administration of a research project (includes hired students). 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If the RA has direct contact with participants, specimens (e.g., consenting, blood work) please provide copies of relevant documentation of Workplace Safety training, Immunization, Mask Fit testing, Phlebotomy certification (if applicable) from your originating institution. Data Abstractor (DA) (Section #2) An electronic medical records data abstractor reviews patient files and abstracts (i.e., extracts) key de-identified data. Research Volunteer (Section #3) All research volunteers MUST BE APPROVED by the Department of Research & Innovation prior to onboarding. An individual who voluntarily performs tasks for, and/or provides services to a QPI in conjunction with a specified research project without monetary compensation or academic credit. Researcher Volunteers have the opportunity to gain first-hand experience with research conducted in a clinical setting at MGH TEHN, under the supervision of a QPI. A volunteer should never be taking on the work of a paid employee and approval for a research volunteer must be sought out by the Department of Research & Innovation prior to submission to Volunteer Services for onboarding. A rationale will be required to justify why a volunteer is required. No funding is not an acceptable reason. For further information regarding the differences between a volunteer and employee, please refer to the  HYPERLINK "https://www.ontario.ca/document/your-guide-employment-standards-act-0/employee-status" Employee Standards Act (ESA) Please note: any honorarium or monetary payments made to a voluntary over $500.00 will be deemed an employee of Qualified Investigators under WSIB Act and all provisions of coverage in the event of any accident or injuries. Research Study Monitor (Section #4) A research monitor oversees/monitors the progress of a research trial whose role is to protect the safety and well-being of human participants. They ensure that the study is conducted and data are handled in accordance with the protocol, Good Clinical Practice, and applicable ethical and regulatory requirements. The monitor is independent of the team conducting the research involving human participants. For access to MGH TEHN research, a copy of the Research Monitors CV and certifications must be submitted along with this form including the documents as outlined above. Adjunct Researcher (Section #5) Adjunct Researchers are nominated and sponsored by TEHN Researchers according to the TEHN Adjunct Researcher policy.      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