Tuesday 1 November 2011

Role Of Sponsor In The Medical Trial


Sponsor one of the three key personal of the medical trial. The role of the sponsor is active throughout the clinical trial phase. He is responsible for disclosing the safety information of the drug to the local investigator and test study treatment with the other treatments for any potential interactions. He has to monitor the results of the study as they come in from the various sites, as the trial proceeds.

He may approach Data Safety Monitoring Board to ensure the safety of the medical treatment. He even handles the responsibility of framing the correct information in the informed consent to make the volunteer know about the risks involved in the clinical trial before giving his acceptance for the participation. It is also the responsibility of the sponsor to translate the informed consent into the native language of the percipient to make understand the content better. The sponsor even collects the adverse reports from all the investigator sites and informs all the investigators about his judgment about the effects whether they are the result of the study or not.

No comments:

Post a Comment