INVESTIGATOR INITIATED TRIALS

August 24, 2021

INVESTIGATOR INITIATED TRIALS

Investigator: An individual who actually conducts a clinical trial at the trial site.

Sponsor: An individual who initiates a clinical trial.

Sponsor-investigator: An individual who both initiates and conducts an investigation

Investigator initiated clinical trial: It is a clinical trial in which the investigator assuming the responsibility for initiation, conduct and management of clinical research and the individual is known as Sponsor-investigator. It is also called as sponsor-investigator trials. The requirements applicable to sponsor investigator are both those applicable to an investigator and sponsor.

RESPONSIBILITIES OF SPONSOR-INVESTIGATOR:

• The sponsor-investigator must submit IND yearly report within 60 days which contains Summary of frequent and serious adverse events, all IND safety reports submitted in the course of the earlier year, a list of participants who withdrawn due to adverse events

• Monitoring of study, safeguard of human subjects right, safety and well-being.

• Sponsor-investigator must retain suitable case histories and records including case report forms, supporting data, signed and dated consent forms, source documents.

• Evolving study protocol and subject associated documents

• Accomplishment of responsibilities according to the protocol and in agreement with regulatory authorities

• Individually publishing the study results

• safeguarding that the study medication or device is placed in a harmless place with restricted access in clinical trial

• Ensuring that all regulations and guidelines are adhered to FDA code of federal regulations and international conference of harmonization-good clinical practice guidelines

• Selecting qualified investigators, sites and monitors and safeguard that the study site attain the applicable institutional review board approval

• Safeguarding that the study is accompanied according to protocol and good clinical practice guidelines