For REB Use Only /

St. Joseph’s health centre (REB)

Study Closure Report Form

Handwritten submissions are NOT acceptable

Complete this form and submit two (2) signed hard copies to the SMH REB.

Submissions that are incomplete will be returned to the submitter.

Use this form ONLY if you are requesting closure of the SJHC REB study file.

Date:

REB #: Study Title:

SJHC Principal Investigator (or Local Study Lead):

External Investigator (Main PI):

Study Approval Date:Study Approval Expiry Date:

1. Completion Summary
If you answer ‘NO’ to any of the following, then this study should remain OPEN.
All participant involvement is complete for this site. / Yes No N/A
All data collection is complete for this site. / Yes No N/A
All data clarification is complete for this site. / Yes No N/A
All data transfer is complete for this site.
All access to participants’ health records is complete for this site. / Yes No N/A
Yes No N/A
2. Reason for Closure
Study completed / Study never received funding
Principal Investigator left/leaving institution / Insufficient participant accrual
No enrollment at site (e.g. competitive enrollment)
Withdrawn by Investigator. Explain:
Withdrawn by Regulatory Authority. Explain:
Withdrawn by Sponsor. Explain:
Study closed due to safety reasons. Explain:
Other. Explain:
3. Summary of Study Participant Enrollment
No enrollment. Reason:
Retrospective Study Data (e.g. Retrospective Chart Review/Biological Specimen Studies, etc.)
Complete each line
Number of charts reviewed/specimens accessed to determine eligibility.
Number of participant charts in retrospective chart review.
Number of biological samples utilized for this study.
Prospective Study Data (e.g. Clinical Trials, Qualitative Studies, Registries, Prospective Chart Reviews, etc.)
Complete each line
Number of participants approached by SJHC study site personnel.
Number of participants consented by SJHC study site personnel.
(should equal sum of a. to e. below)
a. / Number of participants consented, but have not yet started intervention/data collection.
b. / Number of participants who have withdrawn their consent or have been withdrawn (e.g. screen failures, early withdrawal/termination).
c. / Number of participants currently receiving study intervention (e.g. study drug, questionnaires, tests, or procedures done for study purposes).
d. / Number of participants currently in post-intervention follow-up.
e. / Number of participants who have completed the study (including completed follow-up) and no further contact for study purposes is planned.
4. Safety Reporting
Have all reportable local serious adverse events been reported to the SMH REB? / Yes No* None
*If no, submit immediately.
5. Publication/Dissemination of Results
Have any articles been published or presentations been given using the results of the study? / Yes No N/A
If yes, please submit a copy of the abstract(s) or provide a list of references:
If no or N/A, explain:
6. Study Data Storage
Study data will be stored in a secure/confidential manner in accordance with applicable guidelines and regulations.
Study data will be retained for (select one):
25 years (for drug, biologic, and natural health product regulated clinical trials)
minimum7 years (for medical device regulated clinical trials)
minimum 7 years (for non-regulated clinical trials)
minimum 5 years (for non-clinical trials) / Yes

DECLARATION BY PRINCIPAL INVESTIGATOR

I confirm that there is no further participant involvement and all data collection, clarification, and transfer is complete (including access to the participants’ medical records).

I warrant that this study was conducted in accordance with the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (TCPS 2), the Ontario Personal Health Information Protection Act (PHIPA) 2004, the St. Michael’s Hospital by-laws, the Catholic Association of Canada Health Ethics Guide, and other relevant laws, regulations or guidelines (e.g., Health Canada Part C, Division 5 of the Food and Drug Regulations; Part 4 of the Natural Health Products Regulations, the Medical Devices Regulations, and ICH/GCP Consolidated Guideline E6).

This study should be officially closed by the SMH REB.

Printed Name of SJHC Principal Investigator / Signature*
*Original Ink or electronic/digital signature / Date

(This form was adopted by SMH REB: Study Closure Report FormVer. 30-Mar-2017)Page 1 of 3