Question: We are looking for the best way of standardizing our filing system of documents issued during non-interventional trials (e.g. Post-Marketing Surveillance). These trials are getting more and more structured and …
Using the Reference Model in Non-Interventional Trials Read More »
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 …
