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...
We are using eTMF (electronic Trial Master File) more and more in clinical trials, but the sponsor eTMFs are not always met the requirements by the inspectors, which resulted several recent inspection findings. Here are 7 recommendations for how to ensure inspection readiness of eTMF. Prior to...
At its meeting in London, UK, March 2018, the EMA Management Board was informed about progress in the development of the EU portal and database. Based on the experience with this complex development so far, the developer has submitted a revised project plan with improved project...
The Ministry of Health and Family Welfare in India has issued the draft Clinical Trials Rules 2018. It applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. It will come into force after its...
The FDA has announced that it will disclose clinical study reports (CSRs) in a pilot program from Jan.2018. Participation in the pilot is voluntary for sponsors, and limited to up to 9 recently approved new drug applications (NDA) with a focus on products that are...
FDA has updated the information sheet on payments and reimbursements to research subjects. The new sheet states that reimbursement for travel expenses is acceptable. FDA does not consider reimbursement for travel expenses to and from a trial site and associated costs (including airfare, parking and...
