I agree with previous comments about the DHF being a living document. I would like to add on the previous ideas about the advantageous of it being a l...

I would like to add some points about shutting down/pausing studies. It doesn't take much to make it happen. The IRB has a lot of power in this matter...

I would like to answer the original question and add the points about general clinical trials without the animal studies that have not been mentioned....

At the lab where I used to work, we had both prospective clinical study which is collecting data in real time or retrospective which is using old data...

I think I actually have a different opinion with you guys. I worked in clinical research for at least 2-3 years in a hospital in NJ and I wouldn't min...

Thanks, @merzkrashed. Then, is it recommended to internal audit themselves and then hire an auditor?

@gh56 and @merzkrashed had talked about the 3 basic concepts of QM principles: system approach, process approach, and factual approach. I would like t...

hi guys, I am a bit confused about internal audit, if anyone knows, could you please clarify? In the lecture, (slide 9), it's stated that for intern...

I agree with previous comments about Correction being the short-term solution and Corrective action, on the other hand, is a long-term solution. Corre...

Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 commen...

I agree with previous comments about internal audits and would like to sum up and expand the pros and cons for this type of audits. PROS 1. It helps ...

I believe the above comments are solutions from the business/company admin side. To answer Fady's question from the employee perspective, I believe th...

Thank you for an interesting question with a lot of different views. In this unforeseeable situation, it's difficult to say "to kill" or "not to kill"...

I agree with previous posts about funding being the key driving force to support change and innovation. I would like to add in the timing factor and m...

There are three primary types of obsolescence: technical obsolescence (new technology surpasses the existing technology), functional obsolescence (whe...