Study Director
Study Director means the individual responsible for the overall conduct of the non-clinical health and environmental safety study.
The Principles of Good Laboratory Practice further specify that the Study Director is the single point of study control and has the responsibility for the overall conduct of the study and its final report.
Click here for more information on the significance of the role of the Study Director.
The significance of this important role can be seen from just some of the Study Director's responsibilities
These include:
- Approve the study plan and any amendments to the study plan by dated signature
- Ensure the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel during the conduct of the study
- Ensure that study plans and amendments and Standard Operating Procedures are available to study personnel
- Ensure that the procedures in the study plan are followed, assess and document the impact of any deviations from the study plan on the quality and integrity of the study and take appropriate corrective action if necessary; acknowledge deviations from SOPs during the conduct of the study
- Ensure that all raw data generated are fully documented and recorded
- Ensure that computerised systems used in the study have been validated
Further responsibilities when completing the study are covered in Module 07 of this course
