We (Pulmonary Clinical Research study staff) are responsible for ensuring all pharmacists and all nurses are trained on a study and amended documents

Why are we not responsible for ensuring all pharmacists and all nurses are trained on a study?

What SOP(s) do CTSI and IDS follow when it comes to how we document for the study?

With IDS and CTSI following these SOPs now, we don’t need to document anything for them, i.e. on the DOA, training, etc.

CTSI and IDS need to pull current documents from ERICA

How do IDS and CTSI get current documents (like an amended protocol)?

When we get a new pharmacy manual, the coordinator should immediately send it to IDS

You should tell the Regulatory Coordinator, as soon as you know, who the lead nurse will be and what the CTSI protocol number is

If the initial consent is signed at a visit in CTSI then CTSI can write their protocol number on the original consent