Home Forums General Discussion Forum ICH E8 8.2.12 and the use of “or”. Reply To: ICH E8 8.2.12 and the use of “or”.

Fran Ross

Unfortunately, there’s no one answer. One trial can have more than one type of lab (central, country-specific, site, etc.), necessitating different types of “credentialing” records.

Collect the type of records that qualify the lab for that particular trial, and don’t worry about the ones that don’t apply.

As oft repeated at GCP conference last week (MHRA, FDA and Health Canada) – one size does not fit all.