Hi Kim!

So, Clinical Trials follow exact processes and procedures. These rules are defined in TCPS2 (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), found here:

• https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html

In a nutshell - it defines the rules of engagement of clinical trials / studies.

One such rule is that the trial subject (patient/volunteer) must be informed of all activities that directly impacts them - via informed consent. This information is contained in the Informed Consent Form (ICF); which the patient-participant signs; acknowledging their awareness of study activities. Study activities must be included in the ICF and may include:

• sample collection: tissues, biofluids

• responses to surveys, EEG, ECG, observations...

If samples are collected, the ICF stipulates where the samples are stored (biobank), analysed and where the analysis results are stored. All 3 locations - if not the same - must be listed individually; with their associated activity/role. There may be 2 locations listed for sample storage: prior and post analysis.

If samples are being shipped outside of Canada (or even to another province) this must be specified with an address in the ICF.

With regards to patient data to be included in the trial data set, this only happens after signing the ICF. lf something from your health record is being collected - this too must be clearly stated in ICF. Usually, a study doctor (principle Investigator or PI) will scan your health record to identify you as a potential candidate. Only if you meet their criteria - and you have consented to be approached for study - will they contact you to offer an initial meeting.

All to say: ICF and clinical trials are precise things and activities.