Human resources

 

The demands in terms of data quality are very stringent to ensure that outcomes of clinical trials meet ethical and regulatory criteria. Therefore, staff employed at potential research sites need to be well informed, motivated and trained in the conduct of clinical trial sites to ensure successful participation in clinical trials.


 

Suitable and qualified for clinical trial: All staff must be adequately trained and qualified to perform tasks in a clinical trial. This is to protect the research participant and ensure integrity of the data.

 

Motivated: All staff performing tasks in a clinical trial should have passion for performing their tasks appropriately with enthusiasm as well as with an understanding of the importance of their contribution to the clinical trial process.

 

Available resources for clinical trial scope: The conduct of a clinical trial requires the performance of multiple tasks with accuracy and within prescribe time frames. In order to effectively perform these tasks, the investigator needs to have sufficient resources.

 

Training (through ongoing feedback mechanism): With all process there is a need for continuous improvement. Training and feedback is a key component in the quality management process.