Protocol Forms and Guidelines

FORMS:

Submitting Protocols for Review (hard copy and electronic)

Hard copy submission:
Please submit hard copies (1 original plus 9 copies) of Annual Renewals and new Protocols to Tazyia Lakkotrypis, 33 Russell Street, Room T117. Copies should be double-sided and stapled. Original should be single-sided and binder-clipped. CVs and TCPS should be sent to Tazyia Lakkotrypis electronically. Donot include these in the hard copy submission.

Final Reports:
Final Reports should be submitted in paper form (1 original plus 1 copy - signed). We recommend that you submit double-sided copies of Final Reports and any supporting documentation.

In addition to hard copy submission:
Please submit Annual Renewals and new Protocols (excluding CVs and TCPS) electronically to Evelyn Prasad

NEW: Electronic submission. Files should be sent individually and not scanned into one PDF document.

Expedited Review

Applications for expedited review require the same materials as for full review but one (1) paper copy only to Tazyia Lakkotrypis and an electronic copy sent to Susan Pilon (Susan_Pilon@camh.net). There is no deadline for applications for expedited review.

In order to fill in these forms you'll need to have Adobe Professional software installed on your computer. Once these forms are completed, please do FILE SAVE AS to save this information on your computer. These forms cannot be saved on this site.

NEW PROTOCOLS:

1a. Human Subjects Research Application Form - TAHSN - (Revised: March 2006) - MS Word

1b. Required CAMH General Checklist (Revised: January 2012) for ALL research protocols - PDF

EXISTING PROTOCOLS:

2. Annual Renewal of Ethics Approval (Revised January 2012) - (for CAMH only) - PDF

3. Final Report for the Research Ethics Board (Revised September 2010) - (for CAMH only)- PDF

4. Serious Adverse Event (SAE) report form (Revised June 2010) - (for CAMH only) - PDF

5. Protocol Deviation Reporting Form (Revised June 2010) - (for CAMH only) - PDF

GUIDELINES:

1. Human Subjects Research Guidelines- Revised March 2006 - (TASHN) - Word version

2.    Human Subjects Research Application Form Required Checklist & Guidance Materials (CAMH)
      Revised January 2012 - Includes Consent Form, Guidance ("CF") and Consent Form Sample - PDF

3.    SOP's for Obtaining Consent for Research Studies - PDF

4.    NEW - SOPs for Studies involving Genetic Sampling: Research Ethics Board Requirements - PDF
      Revised March 2011

5.    For studies involving PET (Revised June /03) - PDF

6. Handbook for Good Clinical Research Practice (GCP) - WHO 2002 - PDF