The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research organisation (CRO)/vendor, are carried out in accordance with the protocol, written agreements, GCP and local requirements. Especially, when the trial tasks are outsourced to different CROs/vendors at the same time,...
According to the updated ICH GCP, section 5.2.2: The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s). The challenging question is how to ensure...
The investigator should agree to archive the documentation (both electronic and paper-based records) during the retention period as required according to GCP 5.5.11 - 5.5.12. General practice is 15 years after end of trial or longer. If the investigator cannot archive the documents at the...
The use of e-TMFs and electronic archiving generally requires the digitisation of paper records to generate electronic copies of the documents. When original paper TMF documents are transferred to an electronic format (digitsation), the process of transfer should be validated in order to ensure that...
According to the European Commission CT-3: “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use”: The sponsor must ensure that all SUSARs are reported to the authorities as soon as possible; within seven...
According to GCP addendum 4.2.5: The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site. The question is: How to define an adequate oversight/supervision by the investigator? When the investigator has agreed to...
One of the most frequent critical GCP findings is when the in-/exclusion criteria were not followed. Often, the screening period varies several days in order to complete all the screening tests. Even the investigator is convinced of the subject’s suitability, the investigator should wait with...
