Ottawa Health Science Network Research Ethics Board (OHSN-REB) /

Conseil d'éthique de la recherche du réseau de science de la santé d'Ottawa (CÉR-RSSO)

ANNUAL RENEWAL REPORT

1. REPORT DATE:
2a. Protocol Number:
2b. Protocol Title:
3.Principal Investigator
at The OttawaHospital:
4a.Co-Investigators:
4b.Have any co-investigators been added or removed since the last approval? Yes No
If new investigators have been added, include a letter or Amendment Report with the Additional Co-Investigator page with their original signature.
5a. Most recent approval ‘expiry date’:
5b. Number of research participants who have provided consent ANDenrolled into the study locally, since initial approval(if this is the first renewal for this study)OR last renewal report date(if this is the 2nd/subsequent renewal for this study):
5c. Total number of research participants who have provided consent AND enrolled at this site since initial OHSN-REBapproval (if this number exceeds the currently approved sample size, then refer to Section 7):
5d. Number of local withdrawals since initialOHSN-REB approval(if this is the first renewal for this study)OR last renewal report date(if this is the 2nd/subsequent renewal for this study):
5e.Total number of withdrawals at this site since initial OHSN-REBapproval:
5f. Reason for withdrawals:
6. Projected date of study completion(this should reflect the information provided in the initial application and/or the information provided in Section 7)
Note:If the projected date of study completion has been extended, please confirm that there are sufficient funds and/or resources in place to extend the study to the new date you provide.

ANSWER ALL OF THE FOLLOWING QUESTIONS:

7a. Yes No Has there been a departure from previously approved research. If yes, please specify:

- Completion date change/sample size increaseYesNo

or decrease?

- Inclusion/exclusion criteria? Yes No

- Source of subject (participant) population?Yes No

- Source of volunteer population (if applicable)? Yes No

- Other? Describe:Yes No

7b. Yes No Has an amendment formbeen submitted to the OHSN-REB for review of any of the

above changes?

If yes, provide approved protocol version date: , or still pending

Provide the currently approved protocol version date:

7c. Yes No Have any unexpected side effects, adverse events, or findings been noted since last approval?

Has the OHSN-REB been informed of these? Yes No

If yes, date submitted to REB:

If no, justify:

7d. Yes No Has any information appeared in the literature, or evolved from this or other similar ongoing studies, since the date of last approval that might affect the OHSN-REB’s or the research participant’s perception of the risks and benefits of the study?

Note: if yes, provide this information and your assessment of it in the section on progress of the study.

Has the OHSN-REB been informed of these? Yes No

If yes, date submitted to the REB:

If yes, specify and list any abstracts, presentations, or publications presented at a meeting or seminar below.

7e. Yes No Has the consent form been modified since last approval? Yes No

If yes, has the OHSN-REB been informed of these changes? Yes No

If yes, provide date submitted to REB:

If no, justify:

Provide version date(s) for all currently approved ICF(s):

7f. Yes No WRITTEN INFORMED CONSENT has been obtained throughout the life of the study and if recruitment is still open will continue to be obtained from all research participants,or their next-of-kin/legal representative.

7g. Yes NoHave any new conflicts of interest arisen since initial approval (if this is your first renewal for this study) OR last renewal report date (if this is the 2nd/ subsequent renewal for this study)?
If yes, provide details:

NOTE:

Any changes to the protocol and/or consent forms must be submitted as an amendment.

Continuing review provides REB approval for a maximum duration of one year.

8. In the space below, briefly describe the progress of the study since initial REB approval (i.e., if first annual renewal) or since the last annual renewal. If recruitment is open but noparticipants have been enrolled during this reporting period, please provide a detailed explanation.

Renewals cannot be considered if this section is not complete.

PLEASE TYPE OR PRINT CLEARLY

Attestation:

  • I attest that, to the best of my knowledge, the information in this continuing review form is complete, current and accurate;
  • As the Principal Investigator, I will continue to conduct this trial in compliance with TCPS2 (2nd edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans); AND with the provisions of the Ontario Personal Health Information Protection Act and its applicable Regulations; 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);
  • As the Principal Investigator, Iagree to promptly report tothe Ottawa Health Science Research Ethics Board (OHSN-REB) any specific:
  • modifications or amendments, such as changes in PI or Co-investigator (if applicable), changes to the consent form, etc.;
  • local reportable events that meet the REB reporting criteria as per N2 CAREB SOP 404 and Addendum and 406, including but not limited to local unexpected, serious adverse events (SAEs), privacy breaches, protocol deviations and any new information that may adversely affect the safety of the participants or significantly affect the conduct of the trial;
  • trial progress report (renewal/ continuing review form), annually or as often as requested by the REB;
  • trial completion or termination

Signature of Principal Investigator Date

NOTE: You must keep a copy of this form for your study file.

Updated November 24, 2017Page 1

Please forward to; Civic Campus, Box 675, 725 Parkdale Avenue, Ottawa, Ontario, K1Y 4E9,

613-798-5555 extension 16719, Fax: 613-761-4311