NHMRC risk-adapted clinical trial guidelines

In 2018, the NHMRC released three clinical trial guidance documents under the safety reporting guidelines, which are valuable for anyone working with, conducting, or interested in best-practice clinical trials.

These three documents provide assistance to Coordinating Principal Investigators (CPIs) who are planning trials and help provide insight around understanding and reporting serious breaches of conduct to the Therapeutic Goods Administration (TGA). The NHMRC Clinical Trials Unit closed shortly after they were released, and we would like to bring them to your attention as useful resources for CTNs.

These highly relevant documents can be found on the NHMRC website in the following locations: