id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-032607-bn8g02gi	Wake, Melissa	Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort	2020-09-24		.txt	text/plain	8359	400	44	Keywords: Research methodology, Randomization, Registry trials, Multiple baseline randomized trials, Trials within cohorts, Population studies, Generation Victoria (GenV), Clinical trial as topic, Children, Intervention Background Randomized controlled trials (RCT) provide high-quality evidence with regards to the effectiveness of therapies and prevention and are critical to guide translation and optimal resource allocation. If feasibility (potentially demonstrated through pilot studies) and mutual alignment appear likely [29] , the trial would proceed to a partnering agreement that defines at least the following 8 items: 1) Which GenV trial model is being followed; 2) Design and high-level (or draft) protocol; 3) Timelines; 4) Data sharing and governance plans; 5) Status of ethical approval; 6) Communication with participants, including information statement and consent; 7) Trial oversight and 8) Capacity assessment, including trial quality, human resource and funding.	./cache/cord-032607-bn8g02gi.txt	./txt/cord-032607-bn8g02gi.txt