FAQs

Every artifact that is specifically identified in chapter 8 of ICH GCP has the relevant citation listed. In addition, where text elsewhere in the ICH guideline refers to a trial …

Are all ICH codes included in the TMF Reference Model? Read More »

ICH-GCP only uses the word “signed” in relation to 5 TMF documents: protocols and amendments; agreements/contracts; completed consent forms; completed case report forms; and CRF correction signature sheet / signature …

Which TMF documents require a signature? Read More »