COVID-19: Guidance for Investigators

Overview:

As the current Covid-19 situation develops, Investigator sites may see the closure of clinics, restricted travel for staff and participants and redeployment of research staff which may adversely impact protocol compliance for participants already enrolled into clinical trials. Protecting participants’ safety and maintaining duty of care to trial participants during this uncertain time is of paramount importance.

Regular contact with participants and vigorous record-keeping will help protect participants’ safety and well-being and help ensure data integrity.


Frequently Asked Questions Document

COVID-19: Clinical Trial Guidance and contact details for Research teams during exceptional circumstances

FAQ


NOTE 1 – 10th March 2020 - maintaining protocol compliance during exceptional circumstances

Guidance for Investigators - NOTE 1 (Updated - V3)



NOTE 2 – 12th March 2020 - Guidance from the MHRA regarding protocol compliance during exceptional circumstances

Guidance for Investigators - NOTE 2



SOP Waiver - GCP Training

During the Global Health Covid-19 Pandemic this waiver to the above detailed Standard Operating Procedure will extend the required frequency of Good Clinical Practice Training as detailed in SOP 2.0 v6.1 from 2 years to 3 years.

SOP Waiver - GCP Training



GCP Training - GCP Light Information

During the Global Health Covid-19 Pandemic this document provides a Quick Reference/ GCP Light information sheet

GCP Training - GCP Light Information Sheet



GCP Training - GCP light training log

All staff must sign this spreadsheet, one per unit, to confirm that they have read and understand the info sheet. Please refer any GCP questions to the PI, CTO Trainers or other trained personnel

GCP Training - GCP light training log