FDA published the 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 for the duration of the COVID-19 public health emergency.

The appendix to the guidance explains those general considerations by providing answers to questions that the FDA has received about conducting clinical trials during the COVID-19 public health emergency.

Main updates introduced:

• new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video conference, and conducting required post-marketing clinical trials

• information about managing protocol deviations and amendments to ongoing trials
• information on procedures for administering investigational product infusions at home rather than at the clinical trial site.

For more details, please see the guideline from FDA.

Meditrial can help – Contact us for immediate support

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

• Identify patients requiring follow-up
• Conduct investigator and study nurse calls for training to address the situation
• Obtain authorizations for decentralized data collection
• Support to patients for alternative access to needed care
• Prepare procedures and worksheets for remote collection of patient clinical data
• Monitor work instructions and trainings for site support and remote monitoring
• EDC and ePRO solutions to enable study continuity
• Privacy protection measures

Contact Meditrial for immediate assistance in Europe or the US.