Signature Page Prescribed Entity Or Registry Application

Signature Page Prescribed Entity Or Registry Application

Signature Page – Prescribed Entity or Registry Application

Title of Research Study:
Primary CHEO Site Investigator
My signature below attests that:
General Conduct
  • I am responsible for complying with the decisions and responsibilities set out by the REB.
  • I am responsible for ensuring that this project will be conducted, completed and submitted in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, and with all other applicable laws, regulations or guidelines (e.g., Food and Drugs Act and applicable regulations, International Conference on Harmonization Guidance E6: Good Clinical Practice).
  • I will personally conduct or supervise the described investigation(s).
  • I and the research staff are qualified by education, training and experience to assume responsibility for the proper conduct of the research and for protection of human research participants. I will notify the REB of any changes to my qualifications to conduct this research or those of the research staff. I will advise the REB and appropriate organizational officials immediately if mine or members of the research team’s medical license/hospital privileges (as applicable) or health professional license (as applicable) are suspended, restricted or revoked and/or our qualifications otherwise change. I have the adequate resources to properly conduct the research.
  • I will conduct the research following written SOPs.
  • I have signed all necessary documentation, as applicable.
  • I will comply with the institutional privacy and confidentiality conditions, including the provisions of the Ontario Personal Health Information Protection Act and its applicable regulations.
  • I will ensure that the personal health information collected in this study will:
  • Be encoded in a way that would not be identifying of the individual. Codes based on name, medical record number and postal code are not permitted. Variables that can be identifying of the person either alone or in combination will similarly be avoided.
  • Be stored securely in locked areas and access will be restricted to the names listed above. Any personal health information that leaves the site for any reason will be de-identified, password-protected and encrypted. Data will be destroyed at the conclusion of the study.
  • Not be used to contact or attempt to contact patients whose personal information is being researched unless the patients’ express written consent is obtained first.
  • Not be published in a way that could reasonably allow others to identify the patient whose personal health information is being researched.
  • Immediately notify the REB in writing if the investigator becomes aware of any breach of confidentiality or security.
  • Be disclosed except as required or permitted by law.
Conflict of Interest
  • I have declared all real, potential, or perceived conflicts of interest at the time of the initial application, and as they arise.

Primary CHEO Site Investigator continued…
My signature below attests that:
Research Ethics Requirements
  • I will obtain REB approval before engaging in research involving human participants.
  • I will conduct the research in compliance with the approved research and applicable reporting criteria will be followed (i.e., deviations, serious, unexpected adverse events and privacy breaches, unexpected finding or new research that could affect the risk/benefit ratio of the research).
  • I will ensure that no changes in the approved research will be initiated without REB review and approval, except where necessary to eliminate an immediate hazard(s) to the participant(s).
  • I will ensure that accurate and complete records are maintained.
Initial Application
  • I have answered the questions and completed the application form, and take responsibility for the content of the application form and applicable study documentation.
Ongoing/Continuing Review Requirements
  • I will file an annual renewal report, or more frequent reports if required by the REB, and it will be submitted prior to the expiration of REB approval I will advise the REB of any changes in Researchers.
  • I will report to the REB any premature termination or suspension of the research.
  • I will notify the Board when the research is complete.

P.I Print Name: / Signature: / Date:
Secondary CHEO Co-Investigator(s)
My signature below attests to the following:
  • I have read the research protocol and agree to conduct the research project as described in this application.

Name
/ Division Or PSU / Telephone / Email
1.
Signature:
2.
Signature:
3.
Signature:
4.
Research Coordinator(s)
My signature below attests to the following:
  • I have read the research protocol and agree to conduct the research project as described in this application.

Name
/ Division Or PSU / Telephone / Email
1.
Signature:
Authorizations to conduct research
If one of the individuals below is also an investigator in this project, the authorization of their next immediate manager/director/supervisor must be obtained.
Investigators should provide signatories sufficient time to review the protocols An application will only be considered complete when all necessary authorizations have been obtained.
Resource Implications of the Research
My signature below attests to the following:
  • My Department or Service has the resources (e.g.; materials, equipment, personnel, space, and patient population) to support this research.
  • The application is considered to be feasible and appropriate.

Position / Print Name / Signature / Telephone / Date
Patient Service Unit (PSU)
Operations Director
Clinical or Program Director (as applicable)
Authorizations from
Department Chief/Division Head or Professional Practice Leaders
and (as applicable) director of research
My signature below attests that:
I am aware of the proposal and support its submission for REB review.
I am satisfied that:
  • The investigator has the relevant training and experience to conduct the research. I have reviewed a current version of the investigator’s CV.
  • The investigator has the appropriate credentials to conduct the research; including, as appropriate, a valid licence with the relevant RHPA College.

Position / Print Name / Signature / Telephone / Date
Division Head
(For physicians)
Professional Practice Leader
Allied Health Professionals
Director of Research Program (if applicable)

N.B.: If for any reason you wish to revoke your authorization of the submission, please notify the researcher and the REB.

Signature Page – Prescribed Entity or Registry Application – January 2018Page 1 of 5

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