Frequently Asked Questions

1.  Service Providers for a Clinical Trial- Do they need to be on the Task Delegation Log (TDL)?

If any tests/procedures, required for the clinical trial, are considered above standard of care (SOC), then the team leader, charge technologist or manager is required to be listed on the TDL.  Above SOC refers to instances in which there is a change in practice from the norm for the service provider (e.g. the service provider is required to be trained on a trial specific procedure which differs from routine practice, the service provider is required to complete trial related forms, etc.).   

If tests are considered standard of care (including routine tests being completed at incremental time-points) adding service providers to the TDL is not required.

Documentation of training responsibility lies with the team leader/charge technologist/manager and is to be maintained by the area (not study staff).

2.  What do I need to know about the new "Clinical Trials - Interventional" HDR account?

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3.  Where can I find more information about the new Patient Home Visits SOP and Checklist?

For more information, please see the SRI Health and Safety web pages found here.    

4.  We started up a Health Canada regulated clinical trial but didn't screen or enroll any research participants.  Do we need to keep all of our documents for 25 years?

In situations where no study participants are screened nor enrolled in a given clinical trial at the site of a Qualified Investigator (QI), clinical trial records do not need to be retained for the 25-year record retention period. Please note however, that in situations where there are screen failures but no subjects enrolled, all records pertaining to screen failures and the clinical trial should be retained for the 25-year record retention period.
All documents should be kept for 10 years as per  Sunnybrook policy.