FDA Question-and-Answer Appendix in Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency

FDA is issuing guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 public health emergency. An appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

 New QAs included: 

  • Q1. What are some of the key factors that a sponsor should consider when deciding whether to suspend or continue an ongoing study or to initiate a new study during the COVID-19 public health emergency?
  • Q2. What key factors should sponsors consider when deciding whether to continue administering or using an investigational product that appears to be providing benefit to the trial participant during the COVID-19 public health emergency?
  • Q3. How should sponsors manage protocol deviations and amendments to ongoing trials during the COVID-19 public health emergency?
  • Q4. How should a sponsor submit a change in protocol that results from challenges related to the COVID-19 public health emergency?
  • Q5. Can a sponsor initiate virtual clinical trial visits for monitoring patients without contacting FDA if there is an assessment by the sponsor and investigator that these visits are necessary for the safety of the trial participant and it will not impact data integrity?
  • Q6. With the rapid changes in clinical trial conduct that may occur due to the COVID-19 public health emergency, including multiple deviations to address patient safety, what is the best way for sponsors and investigators to capture these data?
  • Q7. If patients are currently dispensed investigational product through a pharmacy at the clinical trial site for self-administration at home, can a sponsor switch that to home delivery without amending the protocol?
  • Q8. If patients are currently receiving an investigational product infusion at the clinical trial site, can a sponsor switch to home infusion?
  • Q9. Considering that there likely will be delays to on-site monitoring of clinical trials during the COVID-19 public health emergency, what are FDA’s expectations in such circumstances?
  • Q10. How do I obtain signed informed consent from a patient who is in isolation when a COVID-19 infection control policy prevents us from entering the patient’s room to collect a signed informed consent form?
  • Q11. How do I obtain informed consent from a patient unable to travel to a clinical trial site where electronic informed consent is not an option?
  • Q12. What factors should sponsors consider when deciding whether to implement remote performance outcome (PerfO) assessments or interview-based clinician-reported outcome (ClinRO) assessments during the COVID-19 public health emergency?
  • Q13. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does FDA have for how I can remotely perform source document review?
  • Q14. I am a sponsor of commercial INDs and electronic common technical document (eCTD) requirements cannot be met due to the COVID-19 public health emergency. Who do I contact for assistance?
  • Q15. During the COVID-19 public health emergency, certain patients may no longer be able to travel to a central location for protocol-based treatment that is scheduled on a recurring basis. Can the investigational product intended for infusion be shipped to a local health care provider who is not a sub-investigator to administer the infusion to a patient while still maintaining integrity of the trial? If so, what else would be needed regarding trial monitoring and institutional review board (IRB) oversight?
  • Q16. If a subject is unable to receive the investigational drug from the trial site but the product is FDA-approved for other uses, can the patient or health care provider secure the product commercially or is this considered the sponsor charging for the investigational drug under 21 CFR 312.8? Can the sponsor reimburse trial subjects for their out of pocket expenses in getting the drug commercially?
  • Q17. Throughout the guidance, FDA recommends that sponsors consult with the review division for certain changes to ongoing clinical trials. For drugs and biologics, is this a reference to scheduling a Type A meeting? How should sponsors contact FDA regarding device clinical trials?

See document here: https://www.fda.gov/media/136238/download

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