Montreal Neurological Institute and Hospital

Version 2002.10.31 CONTINUING REVIEW (1) MONTREAL NEUROLOGICAL INSTITUTE AND HOSPITAL

RESEARCH ETHICS BOARD REQUIREMENTS

for submission or resubmission of an APPLICATION FOR CONTINUING REVIEW

Please complete this application for your submission

Make certain that the study site, protocol title and version date appear on every page of consent documents. If the protocol calls for the recruitment of special subjects (those with any organic features, special psychiatric conditions such as psychosis and depression involving danger to self and others), attach also the PROTOCOL INVOLVING SPECIAL SUBJECTS form in 13 copies. In cases of first and second renewals, unless procedures or documentation have been altered, submit applications in only two (2) copies. In cases of third renewals or whenever procedures or documentation have been altered, submit applications in Thirteen (13) copies. Deliver your submission to the Secretary, Victor Epp, of the Research Ethics Board (REB) (Room 686, local 1046) fifteen (15) days prior to the meeting at which it is to be reviewed. (Letters of approval from the Magnetic Resonance Research Committee or the PET Working Group must be brought at least eight (8) days prior to the scheduled meeting.) MNI/MNH Research Ethics Committee usually meets on the last Tuesday of every month. However, investigators are requested to verify the date of upcoming meetings with Mr Epp.

1. a) Title of project:

b) Does this protocol involve any patient population?

c) Does it involve the administration of therapy?

2. Name of principal investigator:

3. a) Associate investigator(s) at MNI/MNH:

b) Other associate investigator(s) (indicate affiliations):

4. Name(s) of any physician(s) from MNH: DR. ROBERT LISBONA

5. Have there been any changes of investigators involved in the past year? If yes, specify:

6. Date(s) of initial approval and any renewal(s):

7. (a) Number of subjects studied in past year, (1) controls, (2) normals, (3) patients: (b) Number of subjects studied so far, (1) controls, (2) normals, (3) patients: Version 2002.10.31 CONTINUING REVIEW (2) 8. (a) Summary of progress made in past year: (b) Number of subjects, controls and patients to be studied in upcoming year:

9. Be sure to submit Adverse Event Reports as they occur or as you are notified from other study sites. Instructions on how to handle gradations of seriousness may be found on the MNI website

10. Please list publications related to project in the past year:

11. How is the project currently funded? (If a grant, please identify agency and give the grant number)

12. Plans for future funding of the project:

13. Estimate duration of the project:

14. Append copies bearing date of the current version of both English and French consent documents: Please indicate whether the granting agency specifically requires Ethics Board approval of the consent documents;

15. Any additional comments:

16. Signature of principal investigator(s) and date: ______

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