Guidelines & Templates
Guidelines
NMREB
- NMREB Consent Form Guidance Document (Sept. 13, 2018)
HSREB
- Clinical Trial Registration Requirement (May 26, 2016)
- Case Report vs. Research (Jan. 15, 2017)
- Female Partner Preliminary & Pregnancy Information (Sep. 2009)
- Health Canada Attestation Form (Jan. 15, 2017)
- HSREB Updated Main LOI/C (Jan. 16, 2019)
- Institute for Clinical Evaluative Sciences (ICES) (June 6, 2018)
- Magnetic Resonance Imaging (Feb. 1, 2016)
- OBI LOI Confidentiality Clause (May 8, 2015)
- Open Label Extension Study (Jul. 10, 2017)
- Optional Genetic Biomarker Sub-Study Consent Form (Sept. 6, 2017)
Applicable to Both Boards
- Assent Letter (July 6, 2016)
- Continuing Ethics Review (CER) (Mar. 21, 2016) – Initial Approval Date & CER Date Determination
- Coordinated Review for Multi-Site Research
- Data Security and Confidentiality (Aug. 21, 2017)
- Distinguishing Between Quality Assurance/Improvement & Research (Sept.10, 2018)
- General Data Protection Regulation (GDPR) (Jan. 8, 2019)
- Non-Clinical LOI/C (Jan. 16, 2019)
- Open Access/Open Data (Jan. 30, 2018)
- Participant Recruitment (Sept. 24, 2018)
- Translated Documents (Jul. 30, 2018)
- Tri-Council Policy Statement 2 (2014)
- Unanticipated Problem Reporting - Adverse Event (Jul. 10, 2018)
- Unanticipated Problem Report - Protocol Deviation/Violation (Aug. 25, 2017)
The templates below have been created to help researchers create study documentation, and serve as a guide to complement study protocol.
Templates
- Assent Letter of Information
- Classroom Recruitment Script
- Confidentiality Agreement
- Debriefing Form
- Female Partner Pregnancy Letter of Information and Consent
- Female Partner Preliminary Acknowledgement - Optional
- Female Partner Preliminary Letter of Information and Consent
- Letter of Information and Consent: Sample 1
- Letter of Information and Consent: Sample 2
- Muscle Biopsy Subject Screening Form
- Optional Genetic Biomarker Sub Study Letter of Information and Consent
- Participant Photographic Release Form
- Recruitment Email Reminder
- Recruitment Materials: In-Class Recruitment Script
- Recruitment Materials: Recruitment Email
- Recruitment Materials: NMREB Recruitment Poster
- Recruitment Materials: Telephone Script
- Recruitment Materials: SONA/Participant Pool Recruitment
