Skip to main content

Risk Based Clinical Monitoring

BayBiotech.NET

FDA's recommendation of Risk Based Monitoring of Clinical Trials, as published in their Draft Guidance in August 2011.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which was recently withdrawn, stated that the “most effective way” to monitor an investigation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 Details of the draft guidance can be reviewed at the link presented in this blog as above.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.


Comments

  1. UnknownJuly 1, 2013 at 8:47 PM

    Hi, nice post. Well what can I say is that these is an interesting and very informative topic. Thanks for sharing your ideas, its not just entertaining but also gives your reader knowledge. Good blogs style too, Cheers!

    clinical research sites

    ReplyDelete

Post a Comment

Popular posts from this blog

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

Food Safety Bill: A major overhaul of the Food Safety System

BayBiotech.NET The recently passed Food Safety bill is being considered to be a major overhaul of the food safety system in the United States and is considered to change the mission of the FDA, focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs. Under this legislation, food manufacturers are required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out. To read more about it follow the link
Post a Comment
Read more