On 2.May.2017 The National Institues of Health (NIH) and FDA Joint Leadership Council has issued a final version of the protocol template for clinical trial investigators. The NIH-FDA protocol template is primarily intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded...
It encourages the implementation of more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. The ICH GCP Addendum E6 (R2) from Nov.2016 provides a unified standard for the mutual accptability of...
Serious breaches must be reported to the concerned Member States in Europe within 7 calendar days by the sponsor. Serious breach is a breach that is likely to affect to a significant degree the safety or physical or mental integrity of the participants; or the...
