On 21 May 2020, NIHR set out a framework to guide the restarting of NIHR research activities which have been paused due to COVID-19.

Sponsors planning to restart trials or to initiate new clinical trials should take account of the principles described in the NIHR Restart Framework Document and the considerations set out in this guidance. Following a risk assessment, any risks to trial participants should be addressed in the benefit-risk section of the protocol along with risk mitigation measures.

MHRA guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those involved with ongoing studies, those wishing to restart trials that have been paused or temporarily halted, and those wishing to start new studies.

Contents:

1. Managing ongoing and halted trials
2. Submitting paperwork for trials which have been halted or are proposed to be restarted
3. Providing investigational medicinal product (IMP) to trial participants
4. Accountability of Investigational Medicinal Products (IMP)
5. Remote monitoring for trials
6. Changes to the number and type of participant monitoring visits
7. ‘Dear Investigator’ Letters
8. Reporting of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and submission of annual safety reports (DSURs)
9. Protocol deviations and serious breaches
10. Protocol waivers
11. Urgent Safety Measures
12. Participant safety
13. Signatures
14. Help from the MHRA

For more details, please see the official communication from MHRA.

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.