INVESTIGATOR'S RESPONSIBILITIES
A clinical trial investigator assumes the responsibility to conduct the clinical trials in compliance with the GCP guidelines and must be thorough with the use of investigational product as described in the standardized protocols. It's the duty of the investigator to ensure all medical care of the subject, as the subject is wholly dependent on the investigator during the trials .The investigators responsibilities include:
- In case of the subject's premature withdrawal from the trial, the investigator should make an effort to understand the reasons behind the withdrawal adjacent to the subject's rights.
- Before initiating a trial, investigator must ensure the informed consent, written and dated approval from the IRB.
- The investigator should conduct the clinical trial in compliance with IRB but should not implement any deviation in protocol without an agreement with sponsor.
- The investigational product should be stored as specified by the sponsor.
- Premature binding of the drug should be informed and explained to the sponsor.
- Taking care of the informed consent and ethical principles mentioned in the "Declaration of Helsinki".
- Safety and adverse drug reaction reporting.
