Stephen Buia

Change requests mean they need an owner , a potential situation, anticipating potential results, backup information and overall cross departments support.

Suggest adding different levels of change control, from minor to potential adverse to adverse to major to (disaster)☺️ Your choice to success

If you do all this, nothing will get done. Get real and concise and set small sharp parameters. Remember you plan for failure and build for success.

You need to get IRB approval and an Ethics advisory group input and support to go forward. Consent form has to be specifically written and not on the back of a surgical consent form. The medical center has to be totally supportive. Suggest open conference with target audiences to explain programs and all end users involved. Need to provide feedback from research entities on results of the program.

Need goals, strategies and tactics identified and bought into and implemented. Next build a logistical operations platform that can provide a chain of custody for all steps