Data Review & Sign-off

This page is based on the European Medicines Agency Guideline on computerised systems and electronic data in clinical trials which, in turn, is based on ICH GCP and is therefore applicable in other jurisdictions such as Canada.

Responsibility

Data Review

Recommendations

The following is a common approach for academic clinical trials.

Making Best Use of Resources

The Qualified Investigator may delegate responsibility for data review and sign-off to suitably qualified staff. For critical instruments this would usually be a qualified physician. However, provided critical pages are signed by delegated, medically qualified staff, and since final sign-off certifies compliance with the ALCOA standard, final signoff may be undertaken by staff who are not medically qualified. This approach should be agreed with the Sponsor and documented in study procedures.