CLINICAL RESEARCH RESPONSIBILITIES

RESPONSIBILITIES IN CLINICAL TRIAL

       Clinical trials or Clinical research is a process by which new pharmaceutical molecules, medical devices and biologically active agents are evaluated for safety and efficacy and utility to ascertain whether actually they help to treat a disease or not.

     

Clinical Research

       There are mainly three type of personnel who are responsible for conducting clinical trial.

They are Sponsor, Monitor and Investigator.

       Sponsor- The sponsor has to find out the institute or center or hospital where clinical research study site and facilities are available.The investigator is to be selected by the sponsor as per as educational qualification or experience. Before agreement The sponsor should provide a complete information brochure to the investigator or the institution.

      The sponsor confirms the contract with the investigator in the following terms:-

• To conduct the trial in the compliance with GCP.
• To comply with the procedures of data processing such as data handling, data recording and data reporting.
• To give the allowance of monitoring and auditing. 

     The sponsor has the responsibility to provide a Standard Operating Procedure(SOP). The sponsor gives the total information about investigational product which is to be decided for clinical trial. Such information like pharmacological, toxicological, chemical constituent and preclinical data should be accurate to justify the nature and duration of study. The sponsor is also responsible for safety evaluation of the product to be studied.

   Monitor- It is a communication link between the sponsor and the investigator. 

• The monitor should verify the capability of the investigator and the facilities in the institute to conduct the study.
• The monitor should check the availability of the investigational product in specific dose.
•  The new molecule provided to the subject (known as a person who receive the new molecule) in specified time.
• The monitor has the responsibility to ensure the study is conducted as per as Good Clinical Practices (GCP) Guideline and SOP.

  Investigator-  The investigator should be ensure that the proper care is provided to the subjects for any adverse events during the study.The investigator should select the subject which is exactly appropriate for the study. the investigator should ensure the accuracy and completeness of the data from the clinical study which is to be provided to the sponsor.
     
      After all the data is received the clinical research organization can be able to achieve to the decision that the new molecule or biologically active agents are still important to treat the disease or not.