Research Ethics Board

Request for Continuing REB Approval Application Form

  1. Submit a typed, copy of this form with original signature to the REB office for processing by the 1st of the month which your study expires.
  2. Please attach a copy of the current consent form(s). Request for Continuing REB Approval Application forms will not be accepted without a copy of the informed consent form(s)
  3. Please e-mail an electronic copy of submission materials to
  4. Send a hard copy to attn: Alexandra Chappell room 744 790 Bay Street

**A suspension of approval may occur if the REB office does not receive the complete study ** reviewapplication form by the first day of the month preceding the annual review expiry date

***Please ensure all research team members have completed the appropriate research training*** (N2/CITI e-learning):

Responsible Conduct of Research (RCR)

Good Clinical Practice (GCP)

Basic Biomedical Research Ethics

SECTION 1 Study Information

Study Title:

WCH REB #:

Expiry date of REB Approval:

Site Principle Investigator:

Sponsor/Funder:

Is this an Industry-Sponsored/Supported study?

No
YesIf YES, complete the below table

Invoicing Information for Industry-Sponsored/Supported Studies. A $500 fee will be invoiced when applying for renewal.
Invoice to the Following Company:
Contact Name:
Telephone: / Email:
Street Address: / Suite:
City: / Province/State:
Country: / Postal/Zip Code

SECTION 2:Status of the Open Study (check all that apply)

No enrollment to date
Actively Recruitingparticipants
Actively Enrolling participants
Study intervention/procedures/Data Collection is ongoing
Post-Intervention/Follow-up of Participants
Intervention & follow-up complete for all WCHparticipants – data analysis and/or data transfer to (i.e. sponsors or coordinating centres)

SECTION 3: Summary of Participants at WCH

Number of participants/Chartsplanned
Number of participants screened
Number of participants consented (if applicable)
Number of participants consented but did not meet inclusion criteria (if applicable)
Number of participants prematurely withdrawn from study
Number of participants receiving study intervention / actively completing study procedures
Number of participants in post-intervention/procedural follow-up
Number of participants that have completed follow-up

Version Date: 25-June-2013Page 1 of 4WCH Request for Continuing REB Approval Application Form

Women’s College Hospital REB – 790 Bay Street, Room 744, TorontoONM5G 1N8

Telephone: 416-351-3732 x 2723 email:

SECTION 4: Study Summary

  1. Please provide a brief summary of the progress of the study to date (i.e. recruitment issues, preliminary findings, including a description of amendments which have been submitted).
  1. Is there any new information in the literature or from other recent studies that would change the rationale or risk/benefit ratio for this study (e.g. changes in standard of care, new information about side effects, approval of another drug for this indication)?
    YesNo
    If yes, please explain and provide any applicable references
  1. Have any patients been withdrawn from the study prematurely or withdrawn consent?
    YesNo
    If yes, please document the reasons for patient withdrawal.
  1. Have there been any subject complaints or feedback about the research?
    YesNo

If yes, please describe.

  1. Have there been any internal serious adverse events (SAEs) since the last approval,
    YesNo
    If yes, please state the action taken in response to the SAEs, and any resulting changes in procedures to detect such SAEs.

a.In the opinion of the Principal Investigator, is there a trend in the internal SAEs?YesNo
If yes, describe.

b.Have there been any deaths related,or not related, to study intervention?YesNo
If yes, provide details.

  1. Has there been a change in the frequency and/or severity of adverse events that would result in a change to the protocol or consent form? Yes No
  1. Is there a data safey monitoring committee/board (DSMC/DSMB) for this project? YesNo
    (If yes, please attach a copy of the most recent DSMB/DSMC report)

If yes, how often does this committee meet? If the DSMB/DSMC has not met in the last year please provide an explanation/justification or state when the next meeting is planned.

  1. Since the last renewal, has there been any change in the Conflict of Interest information provided to the REB for investigators involved in this study? (Potential Conflicts of Interest can include functioning as an employee or consultant to the study sponsor, direct or indirect financial interest in the drug/device or technology involved in the study or receiving honorarium or other benefits from the sponsor).

YesNo

If yes, please specify

Has the study now changed to include collection or banking of tissue or other specimens (i.e. fetal tissue, placenta, blood or other body fluids)?

YesNo
If yes, please specify

Is the contact information on the consent form current?
YesNo

  1. Please provide current PI and study coordinator/research assistant address, telephone and fax numbers, and e-mail addresses.

Version Date: 25-June-2013Page 1 of 4WCH Request for Continuing REB Approval Application Form

Women’s College Hospital REB – 790 Bay Street, Room 744, TorontoONM5G 1N8

Telephone: 416-351-3732 x 2723 email:

Version Date: 25-June-2013Page 1 of 4WCH Request for Continuing REB Approval Application Form

Women’s College Hospital REB – 790 Bay Street, Room 744, TorontoONM5G 1N8

Telephone: 416-351-3732 x 2723 email:

  1. Study Contact Information (i.e. research coordinator, research assistant, research nurse, etc…)

Name:
Address:
Phone Number
Fax:
Email:

Version Date: 25-June-2013Page 1 of 4WCH Request for Continuing REB Approval Application Form

Women’s College Hospital REB – 790 Bay Street, Room 744, TorontoONM5G 1N8

Telephone: 416-351-3732 x 2723 email:

Current consent form(s) attached No consent form(s) for this study

DSMB/DSMC Letter attached All Research Staff Members have completed and submitted proof of completion of all applicable training requirements

Keep REB file open?

Yes No

SECTION 5: WCH Investigator’s Signature

I confirm that I have reviewed any adverse events, if applicable, in a timely fashion during the course of the study and these have been reported to the REB. All revisions to the study protocol and consent form have been submitted. I am not aware of any new information that may affect the continuation of the study or require change in the study protocol.

______

Print Name Signature Date (dd/mmm/yyyy)

RETURN TO:

Attention: REB Coordinator

WCH Research Ethics Board

7th Floor 790 Bay Street, Toronto ON M5G 1N8

Ph: 416-351-3732 x 2723 email:

SECTION 6: FOR OFFICE USE ONLY:

Continuing REB Approval

Review Type:

Send to Full Board

Delegated Review

REB Reviewer Recommendations:

Approval granted without revision

Approve pending revisions/clarifications  Revisions Reviewed  Approval Granted

Approval not granted Approval not Granted

Recommended Approval Period:

1 year 6 months other______

______

REB Chair (or delegate) Signature Date (dd/mmm/yyyy)

Version Date: 25-June-2013Page 1 of 4WCH Request for Continuing REB Approval Application Form

Women’s College Hospital REB – 790 Bay Street, Room 744, TorontoONM5G 1N8

Telephone: 416-351-3732 x 2723 email: