What is monitoring in research?

Monitoring is the systematic process of collecting, analyzing and using information to track a programme’s progress toward reaching its objectives and to guide management decisions.

What is study conduct?

The conduct of a clinical research study involves participant recruitment and management as well as study oversight, maintenance, and reporting.

What is the purpose of monitoring in clinical trials?

The purpose of monitoring is to verify that: The rights and well-being of the human subjects are protected. The reported trial data are accurate, complete and verifiable from source documents.

What is respect for colleagues in research?

Promote their welfare and allow them to make their own decisions. Respect for Colleagues: Respect your colleagues and treat them fairly. Social Responsibility: Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

How does monitoring research relate to research integrity?

Monitoring Research(page 1 of 2) Research by its very nature is a trip into the unknown for the subjects as well as for the entire investigator team. While the IRB has some monitoring responsibilities, it is not constituted so as to visit sites, examine data, interact with subjects, or make decisions as to the nature of an adverse event.

What are the different types of research monitoring?

Several kinds of research monitoring have evolved to deal with these issues. Sponsored clinical trials have monitors who make sure that the primary data are collected and recorded properly. They meet periodically with research coordinators and review their study records. They ensure that the reporting of adverse events is complete.

What is the purpose of a Monitoring Committee?

A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully. Risk associated with participation in research must be minimized to the extent practical.

Who is responsible for monitoring of clinical trials?

Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards .