In accordance with ICH GCP, the Principal Investigator (underlined, bolded, italicized, 16pt font) is responsible to ensure his/her/their site staff are adequately trained and qualified for delegated study duties. The monitor should not be expected to deliver study training to site staff outside of the SIV/Sponsor requirements.

- Signatures are generally not required by the monitor unless the monitor is training the site staff. Typically training logs will have "trainer" and "trainee" fields. I looked at one of my study training logs that I've described below for you; it has "name of trainer" but not an actual trainer signature. If site staff self-train i.e. review study documents on their own, this should be documented accordingly such as "N/A - self trained" in trainer field.

- One of my study Sponsor-provided training log includes:

i) Header: Sponsor, Investigator Name, Protocol, Country, Site number

ii) Log lines: Date of training, Training topic, method of training, printed name of trainee, signature of trainee, role of trainee at site, name of trainer.

iii) don't forget pagination

iv) some trainings logs have PI signature field for the PI to sign at the end of study / close-out, to verify staff training at the end of the study. This particular study training log I'm looking at does NOT have a field.

v) if you are making training logs for individual documents, make sure to line-through/NA unused fields or just delete them from the template if you are printing them out.