Random Musings From The Clinical Trials Guru FDA Clinical Research DCT Guidance 2023: Clinical Research Site Owner Reacts! Ep.715
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Timestamps:
Intro. (0:00)
Strategies to bring the trial to the patient. (3:23)
How remote assessments differ from on-site assessments. (8:30)
Why didn’t virtual trials work? (13:57)
Trial related services should not differ from clinical practice. (18:28)
Sponsor role and responsibility. (23:15)
The investigators role and responsibilities. (27:42)
Documentation investigators sub investigators. (33:42)
More liability, more liability and less control. (38:33)
Safety monitoring plan for patients. (43:39)