About Managing Clinical Training

Clinical Trials involve personnel at multiple sites. Companies and CROs (clinical research organizations) that conduct clinical trials must train and certify these people about those trials. This education is an important aspect of risk based monitoring and helps companies and CROs to reduce monitoring costs and expedite the clinical trail process. Companies and CROs are responsible for making sure that site personnel understand:

• The ethical aspects of research involving human subjects.

• The rules and regulations of regulatory agencies.

• Their roles and responsibilities in clinical trials.

• The appropriate SOPs (standard operating procedures) and work instructions for clinical trials.

• The various aspects of clinical trials, such as their clinical indications.

As part of the planning for clinical trials, administrators create training plans to manage the training of personnel. These training plans include training topics. Users can then track these training topics for themselves and close the topics when they complete them. This tracking provides an audit record of the training for regulatory agencies.