Select Series: Helpful Information from BRANY’s Quality Assurance Team Monitoring
Monitoring plays an important role in the oversight of human subject research and compliments the primary investigator’s oversight responsibilities. There are four major goals of monitoring:
Safeguarding participant’s rights and safety
The protection of participants’ rights is primarily accomplished through an after-the-fact review of the informed consent process and the informed consent form (ICF) to confirm that each participant:
- understood what the study entails,
- was informed of the risks from the study procedures,
- was aware of alternatives,
- understood their participation is voluntary, and
- were notified of significant changes to the study protocol or to any of the risks associated with the investigational products or research procedures.
Monitoring also plays a role in participant safety. In addition to direct examination of important safety data, the monitor reviews relevant supporting documentation to ensure that the investigators, research team and safety monitoring entities are aware of all adverse events or deviations from the protocol that might compromise the wellbeing of participants.
Improving data quality
Ensuring that a research study produces valid, high-quality data is accomplished in three major ways:
- Confirm data integrity and validity by verifying that the research team has adhered to the approved protocol and has followed the tenets of Good Clinical Practices (GCP).
- Certify that all study data is accurate and verifiable, with all study procedures properly documented using best documentation practices (documentation that is attributable, legible, contemporaneous, original, accurate, and complete).
- Performing data validation to confirm that the entries in the study database match the values reported in the original source documentation.
Ensuring regulatory compliance
Monitoring provides an additional verification that all study procedures meet local and federal regulations and follow institutional SOPs. The monitor will also confirm that any deviations from these standards have been properly reported to the appropriate entities and that any necessary corrective actions have been performed.
Facilitate quality and process improvement
The study team can draw upon the monitor’s experience with multiple research projects to find ways to improve study conduct and data collection:
- Recommend ways to streamline study processes while ensuring adequate study conduct.
- Identify potential protocol deviations or data integrity issues prior to their occurrence.
- Assist with developing corrective action plans should any deviations occur.
- Work to resolve queries in a timely manner.
If you want to learn more about monitoring and how to enhance your oversight process, please email your questions to QA@BRANY.com or visit our website at https://www.brany.com/research-auditing-and-monitoring for more information.
