Investigator responsibilities in GCP part 5

This post continues with Investigator responsibilities in GCP 4.2.4:

"The Investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions"

How can this be effectively demonstrated and managed at site level to both CRO's and Sponsors? firstly, consider all people that need to be kept informed. Start on day one at investigator training/SIV. Everyone who receives protocol specific training and who is added to the delegation log must be kept adequately informed. A relatively easy way to facilitate this at site is to ensure the PI and lead research coordinator/research nurse set up a group email address that exactly matches the delegation log and that is updated every time the delegation log is updated. Name the group email the same name as the trial. Research staff can support the PI to send out regular emails that keep the whole team updated on issues at site such as:

• number of patients enrolled

• number of patients in screening

• any relevant local and/or global safety events

• upcoming protocol amendments

• newsletters and/or important emails from CRO/Sponsor

• staff changes at site

• upcoming monitoring/auditing visits

Always remember other people/groups that will need to be kept in the loop - 3rd party providers such as pathology/radiology must also receive relevant communications related to the trial.