Researcher�s Checklist for Submissions by HC120704041932

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									                                                                                  Capital Health Research Ethics Board
                                                                                Centre for Clinical Research, Room 118
                                                                             5790 University Ave., Halifax, NS B3H 1V7
                                                                                   Phone: 473-2126        Fax: 473-5620



Researcher’s Checklist for Submissions
To be completed by                            Date Received:
Research Ethics Office
                                     REB File No.: CDHA-RS/



Research Study

Title of Protocol


Principal Investigator (PI)                          For clinical trials, the PI must have a Capital Health appointment.

Name


Site Investigator                                       Not applicable (clinical trial and/or PI has a CH appointment)

Name


Contact Person for this Research Study (if other than the PI)                                            Not applicable

Name

Phone No.                                                   Fax No.



Principal Investigator’s Signature                                      Sign and date each time you submit this form.



Signature:                                                      Date:

                          (Principal Investigator)                                        (yyyy/mm/dd)


Important instructions and reminders:
  “N/A” means “not applicable”, and dates should be written as yyyy/mm/dd.
  All attached documents should bear a version number and date.

Full Board vs Delegated Review:
  Full Board review is required for all clinical trials (see the definition listed on the EAS Form) and for
     non-interventional studies that present more than minimal risk to study participants.
  Delegated review may be appropriate if:
      The study is non-interventional and presents no more than minimal risk to participants; or
      Additional Capital Health sites wish to participate in a previously approved clinical trial.
Note: A study is considered minimal risk if the probability and magnitude of possible harms implied by
     participation in the research is no greater than those encountered by participants in those aspects of
     their everyday life that relate to the research. – TCPS2




Page 1 of 4                                                                                   REB Version: 2011/08/31
Full Board    Delegated
                            Required Documents
 Review        Review
  1 copy        3 copies    Completed Checklist

                            Letter of Support from the PI’s dept./div./program/service
  2 copies      2 copies
                            Date of Letter:              (yyyy/mm/dd)

  2 copies     2 copies     Letter of Support from the Site Investigator’s dept./div./program/service
  or           or
  N/A          N/A          Date of Letter:              (yyyy/mm/dd)

                            Letter(s) of Support from collaborating CDHA dept./div./program/service

                            Dept. / Div. / Program / Service                Date of Letter
  2 copies     2 copies
  or           or
  N/A          N/A



  2 copies     2 copies     Invoice Request for REB Review Fee
  or           or
  N/A          N/A          Date of Request:                                or      N/A (grant funded / unfunded)

  2 copies                  Letter of Authorization / No Objection from Health Canada
  or             N/A
  N/A                       Date of Letter from Health Canada:                   (yyyy/mm/dd)

                            Approval Letter from the Capital Health BioSafety Committee
  2 copies     2 copies
                            Required for studies involving recombinant gene (DNA) therapy.
  or           or
  N/A          N/A          Date of Approval Letter:

                            Radiological Review Application
                            Required when radioactive material or radiation emitting devices will be used as part of
  2 copies     2 copies     the screening procedures or during the study (e.g., X-ray, CT scan, bone density scan,
  or           or           cardiac catheterization or nuclear medicine scans; MRI and ultrasound are NOT
  N/A          N/A          considered radiation emitting devices).

                            Date Form was signed by Radiology Research:                      (yyyy/mm/dd)

  3 copies      2 copies    Peer review comments from parties within Capital Health
 or            or
  N/A           N/A         Reviewer(s):

  3 copies      2 copies    Peer review comments from external parties
 or            or
  N/A           N/A         Reviewer(s):

  3 copies     2 copies     Correspondence received from another REB (Dal or IWK)
  or           or
  N/A          N/A          REB:

                            Ethics Approval Submission (EAS) Form
  25 copies     3 copies         Clinical Trial                         Date of PI’s signature:
                                 Non-Interventional Study                                         (yyyy/mm/dd)




Page 2 of 4                Researcher’s Checklist for Submissions                      REB Version: 2011/08/31
Full Board    Delegated
                            Required Documents (continued)
 Review        Review
                            Informed Consent Form(s) using REB template
                            ICF Type (e.g., main, genetic)                    Version No.        Version Date

  25 copies     3 copies
 or            or
  N/A           N/A




  25 copies    2 copies     Research Team Contact Page
 or            or
  N/A          N/A          Version No.:                               Version Date:
                            Advertisement for recruitment of participants (e.g., posters, radio or TV
                            scripts, newspaper or internet ads, promotional posters)
                            Type / Title                                      Version No.        Version Date
  25 copies    2 copies
  or           or
  N/A          N/A



                            Supporting Materials (e.g., questionnaires, surveys, measuring instruments,
                            information for study participants, videos, DVDs, participant appreciation items)
                            Item Description                                  Version No.        Version Date
  7 copies      2 copies
 or            or
  N/A           N/A




                            Research Protocol
  8 copies      3 copies    Protocol Identifier (if applicable)               Version No.        Version Date


                            Product Information for test article(s) (e.g., product license, product monograph,
                            investigator’s brochure, device manual)
                            Document Type                                     Version No.        Version Date
  3 copies      2 copies
  or           or
  N/A           N/A



                            Are safety updates attached?                Yes             No




Page 3 of 4                Researcher’s Checklist for Submissions                      REB Version: 2011/08/31
 Full Board     Delegated
                              Required Documents (continued)
  Review         Review
                              Product Information for comparator(s) (e.g., product license, product
                              monograph, investigator’s brochure, device manual)
                              Document Type                                        Version No.          Version Date
   3 copies       2 copies
   or            or
   N/A            N/A



                              Are safety updates attached?                 Yes             No
   1 copy
                              Copy of PI’s current license to practice in Nova Scotia
   or              N/A
                              Required for clinical trials involving drugs, natural health products, or medical devices.
   N/A
                              PI’s completion certificate for the online tutorial TCPS 2: CORE (Course
                              on Research Ethics), an introduction to the 2nd edition of the Tri-Council
   1 copy         1 copy      Policy Statement: Ethical Conduct for Research Involving Humans:
                              http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
                                      * Applies to all submissions received after October 31, 2011 *
   1 copy         1 copy      Site Investigator’s completion certificate for the online tutorial TCPS 2:
   or             or          CORE: http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
   N/A            N/A                 * Applies to all submissions received after October 31, 2011 *
                              PI’s current CV
   1 copy         1 copy
                              Signed and dated within the last 2 years; abbreviated version preferred.
   1 copy         1 copy
                              Site Investigator’s current CV
   or            or
                              Signed and dated within the last 2 years; abbreviated version preferred.
   N/A            N/A
                              Other: List any other documents included with this submission.
   N/A or         N/A or
                              Document Title / Type                              Version No.         Date
___ copies     ___ copies

___ copies     ___ copies

___ copies     ___ copies

___ copies     ___ copies

___ copies     ___ copies

___ copies     ___ copies

___ copies     ___ copies

___ copies     ___ copies




 Page 4 of 4                 Researcher’s Checklist for Submissions                       REB Version: 2011/08/31

								
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