If there's no acting Principal Investigator....

[Federica Bitonti]

I would be interested in knowing what are the expectations in terms of PI's responsability, if say, a PI is dead or removed from his responsabilities and there are patients still ongoing at the site.
is it appropriate to wait for the EC to approve the new one and not perform any study related activities in the meantime, or would a current SUB-investigator be entitled to keep assessing the patients' safety as per protocol?
Expecially if it takes 4-5 months to the EC to approve the new PI, I guess there are GCP /legal/insurance implications in not assessing the patients as per protocol in the meantime, even if the patients are seen as per normal practices (and therefore their safety is not at stake, strictly speaking)?
thanks
Federica

[a123456]

There is a reply under "Investigator Sites" section that might help:-

Although the NRES SOP v5.1 does not specifically mention a "risk based approach", the full text of the NRES SOP does have important clarifications that say that the issue of the absence of the PI must be addressed and various factors affecting the research need to be weighed (i.e. taken into account). A risk based approach would do that.

What the UK NRES REC SOP v5.1 actually says:-
Absence of Chief or Principal Investigator
5.86 From time to time, Chief Investigators or local Principal Investigators may be absent due to annual leave, sick leave, maternity leave, sabbatical or for other reasons. For short absences, the CI or PI is responsible for arranging adequate cover. Where this has not been possible, for example because the absence was unforeseen, the research sponsor will be responsible for ensuring that appropriate arrangements are made for the continued conduct of the study. The care organisation hosting the research is normally responsible for monitoring the conduct of the study.
5.87 In some cases it may be necessary to appoint an acting or new CI or PI. The following guidance may be given to CIs, PIs and sponsors:
Where the absence is likely to exceed 3 months or is indefinite, it is recommended that an acting or new CI or PI should be appointed (see paragraphs 5.67-5.71, 5.77-5.80 and 5.84-5.85.)
Where the absence is likely to exceed 4 weeks but will be less than 3 months, the sponsor should ensure that appropriate cover arrangements are made. The main REC should be notified by letter about cover arrangements for absent CIs. R&D offices at NHS sites should be notified about cover arrangements for absent PIs. For non-NHS sites in studies requiring SSA, the SSA REC should be notified. If it has any concerns about the suitability of the arrangements, it should notify the main REC. The main REC has the discretion to request formal appointment of an acting CI or PI.
For absences shorter than 4 weeks, it is not generally necessary to notify the main REC or SSA REC.

5.88 The above guidance is not prescriptive. Other factors may need to be weighed, such as the nature, duration and progress of the research, the rate of recruitment and the structure of the research team.


I have added underlining for emphasis.

There are some other replies as well that might help

[eznul]

Hi, hopefully someone can help me with my query

'The care organisation hosting the research is normally responsible for monitoring the conduct of the study.' If A Pi leaves the organisation hosting the research , does the organisation have to tell the sponsor that the PI is leaving the organisation even though a new PI is already in the process of being appointed?

[CQAO_GEN]

The sponsor have to be informed ASAP and preferrably before, about PI change and approuve it. This may impact contractual agreement with the investigator site and also to perform regulatory actions (notification of new PI to CA/EC).