FDA and Office for Human Research Protections (OHRP) have relapsed final guidance that answers commonly asked questions on using electronic systems and processes to obtain informed consent. The guidance provides recommendations on the use of electronic system and processes to obtain informed consents such as graphics,...

On 2.May.2017 The National Institues of Health (NIH) and FDA Joint Leadership Council has issued a final version of the protocol template for clinical trial investigators. The NIH-FDA protocol template is primarily intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded...

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