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 living document.
1. Being a living document, DHF will be updated after the development phase as well -> good for transparency, the DHF is the representation of the product you are delivering.
2.…[Read more]

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.
My lab was in a “pause” mode for a few weeks and no one could touch the data or has any experiment running because of some paperwork violation when we used a few consent form that was not updated…[Read more]

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.
“how can you possibly predict that beforehand”? we don’t. There can always be an unforeseeable risk that we hope it will not be there. In all the studies that I have worked in, there was always…[Read more]

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 to be analyzed. The way the studies were organized were so that the previous study can build the groundwork for the next study either as pilot data for a new grant or just a side dataset…[Read more]

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 mind working in clinical trials, maybe as a study coordinator or PI. I found the process of the managing the processes, overseeing multiple ongoing studies and keeping track/chasing deadlines fun. I…[Read more]

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 to add on some other principles that I think are also important:
1. Customer focus: it emphasizes that a business should understand the demand and customers’ needs and expectations. More effective…[Read more]

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 internal audit the company performed by itself and it’s not as serious.

My question is: do companies first do internal audits by the company itself after that a small companies may hire a contractor to…[Read more]