Article | August 30, 2021

Is Your Trial Training Compliant With FDA And ICH Regulations?

Source: Pro-ficiency
clinical trial patient iStock-659270722

Are you outsourcing any of your protocol, GCP, or Safety training for investigations and site staff?

Training is important for study quality and patient safety. There is no point in investing tens of millions in a clinical trial and not training the sites appropriately.

Many training outsourcing opportunities exist from CROs and training companies to assist you with training your site staff which are based on old and ineffective technology, and are not validated according to FDA and ICH standards.

Training can impact people’s decisions which can impact subjects in turn. In if you are providing training in support of a GxP activity, you must provide evidence that the person creating the content was qualified or provide evidence that the person noted actually completed the training. This can only be verified through an audit trail of a validated system.


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