PI Oversight of sponsor vendor staff for DCT Teleheath elements on a CTIMP.

[PedanticResearcher]

There's a growing number of sponsors bringing telehealth components to clinical trial.

This brings with it a growing number of requests for a PI to have oversight of staff or multiple staff that a sponsors vendor may contract or sub contract to, for whom the PI has not met.

This brings with it an uncomfortable feeling. How can a PI sign off vendor staff from a sponsor, for whom they have not met, directly trained, assessed and felt competent for the study, yet is a mandatory component of the study.

There's DCT advice around, largely for the EMA and FDA, but under local guidelines, nothing particularly related to this area.

[a123456]

It’s all about documenting oversight. You might like to do a Risk Assessment of the process and determine what mitigating measures are taken such that a risk proportionate approach to PI supervision is conducted and documented.
Useful references to read:-
EMA EC HMA RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS 13 Dec 2022

FDA Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders DRAFT GUIDANCE May 2023.
FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct 2009.

You might find this EMA Q&A useful:-
https://www.ema.europa.eu/en/human-r...l-practice-gcp
“The investigator should retain the final decision on whether the service provider, intended to support the investigator, is appropriate. The investigator also retains the ultimate responsibility for any tasks involving trial-related medical decisions (e.g. participant eligibility and enrolment, protocol specified medical procedures, assessment of efficacy/safety, evaluation of test results, decision to dispense or make changes to the trial medication) and, the appropriate supervision of the persons or parties undertaking the activities delegated.
Any trial related procedure that is delegated to a service provider should be specified in a written agreement. Where the agreement is between the sponsor and the service provider and involves tasks under investigator responsibility, it should be clear in the agreement between the sponsor and the service provider as well as in the agreement between the sponsor and the investigator that the investigator maintains adequate control and oversight over the contracted tasks.”
ICH E6 R3 Draft has something similar (2.3.1; 2.3.2):-
“The investigator may delegate trial-specific activities to other persons or parties.
The investigator may be supported by the sponsor to identify a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor (
The investigator retains the ultimate responsibility and maintains appropriate supervision of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and data reliability.
The investigator should ensure that persons or parties to whom the investigator has delegated trial-specific activities are appropriately qualified and supervised and are adequately informed about the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties, for example, home nurses arranged by the sponsor). Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience.”


MHRA GCP Guide is always useful.