groups » Global Health Research Process Map » Quality Assurance

Quality assurance

The Quality Assurance Plan should be developed at an early stage. The main goals of the QA plan are to make sure that the trial is able to answer the research question, to make sure data and results are reliable, the study is conducted ethically and in compliance with the protocol and regulatory requirements and the safety and rights of the patients are protected. The Quality Assurance Plan should outline monitoring plans, possible audits and also the setting up of Data Safety and Monitoring Boards and Trial Oversight Committees if required.

Useful resources:
6. The Trial Protocol Tool has a useful section under Safety Monitoring and Adverse Events and RCT Management:
7. A useful SOP on trial monitoring including a risk assessment for determining the level of monitoring required:
8. SOP on Auditing , although please bear in mind this is UK University specific:

To return to the Global Health Research Process Map click the following link:

Please use the comment box to explain any problems that you have with this process step or any solutions that you have found to make this step easier for others. If you have any suggestions for additional resources or guidance, please provide these below.

The information posted in this group may be used for research purposes. If you would prefer your comments not to be used for research purposes please state this when commenting.


  • maepamj maepamj 28 Sep 2022

    Hi Guys, Don't QA and QC e-learning material and possibly certification?

Please Sign in (or Register) to view further.