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Protocol Forms & Guidelines


 

 New Protocols

 
  1. Human Subjects Research Application Form - TAHSN - (Revised: March 2006) - MS Word  - (each new submission needs this form)
  2. CAMH_REB_General_Checklist_rev. May 2016.  (Note: checklist should accompany all new submissions)

  3. CAMH_REB_Quick_Reference_Guide for new submissions_REV.August 2015  (please print this list as a guide when preparing your packages)

 

 Existing Protocols

 
  1. CAMH_REB_Annual renewal Form rev. March 2016 (double-sided and stapled)
  2. CAMH_REB_Final_Report_rev. March 2016 (hard copies only - double-sided) 
  3. CAMH_REB_Serious Adverse Event From (SAE) rev June 2016
  4. CAMH_REB_Protocol Deviation Reporting Form - rev March 2016

    GUIDELINES:     

  5. CAMH_REB_Guidance Materials-Revised December 2013

    1. Human Subjects - Research Ethics protocol form required checklist - REV. - April 2014
    2. General Submission Guide_REV._December_2013
    3. CAMH_REB_General_Checklist_REV_ May_2016
    4. Checklist for Protocols involving genetic samples- REV._Dec_2013
    5. Checklist for clinical drug trials both Sponsor and Investigator-initiated_REV._Dec_2013
    6. Consent form requirements/checklist for clinical trials_REV._Dec_2013
    7. Standard operating procedures for obtaining consent for a research study at CAMH - REV._Feb_2014 
    8. Standard operating procedures for studies involving genetic sampling: Research Ethics Board requirements - REV. December_2013
    9. Guidance re consent forms - REV. April 2014 
    10. Advertising templates - REV. April 2014
  6. CAMH_REB__new wording for PET consent forms - revised August 2014.

  7. Handbook for Good Clinical Research Practice (GCP) - WHO 2002 

NEW:  If the planned project involves Program Evaluation and/or Quality Improvement, please check the iinformation in the link below.

     

          NEW:  Please click on this link for MRI review document. 

           

          NEW:  Additional consent form information.  Please include in all consent forms the following information:

           
          "As part of the Research Services Quality Assurance Program, this study may be monitored and/or audited by a member of the Quality Assurance Team.  Your research records and CAMH records may be reviewed during which confidentiality will be maintained as per CAMH policies and extent permitted by law". 

          Please verify if your consent forms reflect recent changes in the phone extension of the REB Chair, Dr. Padraig Darby.  The new extension is 36876.

           

          OTHER INFORMATION:

          CAMH new logo for consents and advertisements. Kindly click on this link for a copy of this logo.

           

          NEW:  Required copies for submission

          Please note for Annual Renewals and Checklists, 14 (fourteen) copies are required (one original plus 13 copies).  

          Electronic documents should be sent as individual files.  Please do not merge into one document.

           

           

           

           

           

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