At its meeting in London, UK, March 2018, the EMA Management Board was informed about progress in the development of…
The Ministry of Health and Family Welfare in India has issued the draft Clinical Trials Rules 2018. It applies to…
The FDA has announced that it will disclose clinical study reports (CSRs) in a pilot program from Jan.2018. Participation in…
FDA has updated the information sheet on payments and reimbursements to research subjects. The new sheet states that reimbursement for…
The use of e-TMFs and electronic archiving generally requires the digitisation of paper records to generate electronic copies of the…
According to the European Commission CT-3: “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from…
According to GCP addendum 4.2.5: The investigator is responsible for supervising any individual or party to whom the investigator delegates…
There is a clear description in GCP regarding requirement for accountability of investigational medicinal products such as: 4.6.1: Responsibility for…
The Danish Medicines Agency (DMA) has published an article about whether or not FDA 1572 form should be signed by…
One of the most frequent critical GCP findings is when the in-/exclusion criteria were not followed. Often, the screening period…