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FDA's recommendation of Risk Based Monitoring of Clinical Trials, as published in their Draft Guidance in August 2011.
For the first time, FDA provided guidance on monitoring of clinical investigations in 1988
which was recently withdrawn, stated that the “most effective way” to monitor an investigation
was to “maintain personal contact between the monitor and the investigator throughout the
clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to
effect meaningful communication with investigators other than through on-site visits.
This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying critical data steps that are crucial for the safety of the patient as well as for the success of the clinical study. Details of the draft guidance can be reviewed at the link presented in this blog as above.
This guidance is worth reading and is an example of FDA's views on adjusting the regulatory needs in the changing global environment.
FDA's recommendation of Risk Based Monitoring of Clinical Trials, as published in their Draft Guidance in August 2011.
For the first time, FDA provided guidance on monitoring of clinical investigations in 1988
which was recently withdrawn, stated that the “most effective way” to monitor an investigation
was to “maintain personal contact between the monitor and the investigator throughout the
clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to
effect meaningful communication with investigators other than through on-site visits.
This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying critical data steps that are crucial for the safety of the patient as well as for the success of the clinical study. Details of the draft guidance can be reviewed at the link presented in this blog as above.
This guidance is worth reading and is an example of FDA's views on adjusting the regulatory needs in the changing global environment.
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