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# New Content Added to Clinical Trials Guide
- URL: https://www.fdaweb.com/new-content-added-to-clinical-trials-guide/
- Published: 2020-04-17T12:00:00.000Z
- Updated: 2026-09-14T16:11:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146593

FDA has added content to a question-and-answer appendix for its guidance on “[Conduct of Clinical Trials of Medical Products during Covid-19 Public Health Emergency](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20Updates%20Question-and-Answer%20Appendix%20in%20Guidance%20on%20Conduct%20of%20Clinical%20Trials&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=12222&elqTrackId=564CD44F7FF3C1FAB8C4B8101DF08E48&elq=5d74c2de04694a6eba0d3d38bd94945e&elqaid=12144&elqat=1).” The amended appendix includes new discussions on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; [electronic common technical document](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20Updates%20Question-and-Answer%20Appendix%20in%20Guidance%20on%20Conduct%20of%20Clinical%20Trials&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=11847&elqTrackId=7143DD215B1F108EB366AEB49790FCD9&elq=5d74c2de04694a6eba0d3d38bd94945e&elqaid=12144&elqat=1) requirements; and investigational product administration by a local health care provider who is not a sub-investigator. It also includes information for sponsors on who they should contact at the agency about certain changes to ongoing trials, and about obtaining informed consent from a patient who is unable to travel to a clinical trial site due to Covid-19 illness or travel restrictions in situations where electronic informed consent is not an option.

The guidance notes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to Covid-19\. “Although the impact of Covid-19 on trials will vary depending on factors such as the nature of disease under study, the trial design, and in what region(s) the study is being conducted, FDA’s guidance outlines general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity.” The appendix discusses the considerations by answering related questions the agency has received.