Their duties include education and enforcement of applicable GCPs, IRB submissions, creation and maintenance of Form 1572s, financial disclosure agreements, curricula vitae, and regulatory documentation. An on-site Contracts Administrator specializes in the timely turnover of legal documentation necessary to begin a study.

CCT works with local independent IRBs that have extensive experience working with the local population. As a result of our track record for quality and safety, we receive quick turnover of protocols and amendments, and excellent continuing review of studies. The IRB for our Early Drug Discovery clinical trials meets oftento ensure rapid review of protocols and amendments.

Once a protocol or amendment is received, it requires approximately two weeks to obtain an IRB review.. The IRB will review, vote, and usually generate an approval letter for a study after their meeting without delay. In most cases, there is same-day turnaround for expected reviews. Patient recruitment can commence immediately. The first patient is usually enrolled within four weeks from the start of this process.