Frequently Asked Questions
Does GCP Training have to be from CITI Training or are other training websites acceptable?
GCP training from any valid, recognized source, with appropriate documentation that the CCC will review and sign off on is fine. In Canada, because the study is regulated by Health Canada, Division 5 training (offered by CITI) is required, as is Handling of Hazardous Materials training. These are considered fairly standard tasks for regulated trial conduct.
Are there any medication restrictions prior to receiving study injection?
Multiple research sites for the PI and SubI: What are your recommendations to set up with separate shipments of vaccines?
Will you be providing the anaphylaxis kits?
We will not be providing the kits as it is standard for hospitals to have this kind of equipment.
What kind of hospitalization documentation do you want, labs, admission note, diagnostics done (CXR, cardiac cath., CT) and discharge summary?
For eligibility, either a hospital history & physical or discharge summary is appropriate. Patient discharge paperwork is insufficient. Clinic notes or progress notes may be submitted in addition as supporting documentation. For endpoints, a discharge summary with investigator summary is requested. In the event of death, a death narrative is requested with autopsy report if available. The death narrative form can be found in the secure study portal. We do not routinely need separate labs or diagnostic reports.
How long does it take to get portal access to the 2 systems?
eSOCDAT: A study coordinator at each site has been granted eSOCDAT access. They can create and activate accounts for all peronnel at that site.