Tools, Templates & Resources

U of A CTO Note-to-File E6(R3) Training Requirements*

Equipment Calibration Note-to-File*

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Interventional Protocol Template*

Observational Protocol Template*

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Therapeutics (drug, biologics, natural health products, etc) Trial Site Initiation Visit Slides + Agenda*

Medical Device Trial Site Initiation Visit Slides + Agenda*

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Qualified Investigator Undertaking (QIU)*

Data Safety Monitoring Board (DSMB)*

Personnel Training Log*

Delegation of Responsibility Log*

Adverse Event Log*

Pharmacy*

Drug Temperature Monitoring*

Protocol Violations/Deviations*

Subject Visit Tracking Log*

Notes-to-File*

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Adverse Events*

Demographics*

Inclusion Exclusion Criteria*

Medical History I*

Medical History II*

Physical Exam*

Prior and Concomitant Medications*

Protocol Deviations*

Randomization and Enrollment*

Serious Adverse Events*

Study Completion*

Visit Checklist*

Vital Signs*

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Therapeutic Product (drug, biological, natural health product, etc) Accountability Log*

Device Accountability Log*

Investigational Product Subject Compliance Tracking Tool*

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Master Identification Log*

Screening and Enrollment Log*

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Subject Contact Log*

Off Study Form*

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Close Out Checklist*

Sample Health Canada Closure Letter*

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Participant Contact Log*

Patient Follow Up Letter*

Subject ID List*

Telephone Log*

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