The investigator should
- Personally conduct or supervise the trial in compliance with the signed Protocol and any amendments
- Personally conduct or supervise the trial in compliance with the applicable regulations and GCP
- Personally conduct or supervise the trial with the IRB
- Read and understand all related literature
- Be aware of potential risks and “side effects”
- Ensure all study staff are informed about obligations
- Protect rights, safety and welfare of subjects
- Complete a CRF for each subject in a timely manner
- Assure initial and continuing review by a regulatory-compliant IRB.
