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Thread: PI delegating PI duties?

  1. #1
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    PI delegating PI duties?

    Is it ever acceptable for a PI to delegate (via file note) the sign off of the delegation log to another Investigator? i.e. the Co-Investigator alone would initial against each entry on the deleagtion log to confirm their duties? As the site agreement is made with the PI, should they not always retain the responsibility to initial the delegation log?

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    This seems a strange idea, as it is the PI who takes ultimate responsibility for the study site and all delegation of tasks, not his/her sub-investigators. In ICH GCP 4.1.5 the PI maintains a list of suitable qualified persons to whom the investigator (PI) has delegated significant trail related duties. That is, the PI must either perform all the duties himself or he must delegate some of those task (but not responsibility for oversight) to suitability qualified and trained individuals. The FDA have a more demanding requirement that each investigator signs their FDA 1572 form, "statement of investigator". This form is signed by the PI to state that:- "I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) .... I agree to personally conduct or supervise the described investigation(s). Also the FDA new guidance on investigator oversight of their investigator centre (Guidance for Industry Investigator Responsibilities, Protecting the Rights, Safety, and Welfare of Study Subjects, Oct 2009), gives a lot more information on what the FDA expects in its ten point plan:- "The investigator should develop a plan for the supervision and oversight of the clinical trial at the site. Supervision and oversight should be provided even for individuals who are highly qualified and experienced."
    There are many Warning Letters from the FDA to PIs who fail to personally perform or personally supervise those they have delegated trial related tasks to. I am sure that the EMA inspector do the same (although their inspection reports are not made public)

    The MHRA GCP Guide makes it clear that they anticipate that only the PI will delegate duties to their staff (11.3.4) :- "In order to demonstrate that the PI has authorised appropriately trained and qualified individuals to undertake certain trial related tasks, a delegation of authority log is used at the site. This document may be combined with the site staff signature log, but should clearly state the name of the person, their role and the activities they are delegated by the PI as well as being signed and dated by the PI prior to the activity being undertaken by the individual. It is not acceptable for the PI to simply sign-off the delegation log at the end of the trial. The delegation is not just a paper exercise; it is documented evidence of appropriate delegation of investigator’s responsibilities".

    RQA (formally BARQA) answered a similar question on their GCP website (www.theRQA.com), about the PI delegating their duty of signing the protocol or alternative contract, to show their agreement. You may find that useful.

  3. #3
    This situation is a little more complicated. This is in a single institution and a study which is open across two separate clinical units with separate clinical/research staff. Because it is one institution there can only be one PI but it doesn't seem appropriate for her to sign a delegation log for staff she has never met or worked with - hence the institution policy has been to delegate this to the co-investigator in the other unit who knows his staff and their ability to run the study in that unit. If the PI countersigned the other Unit's delegation log it would simply be a tick box exercise with little value.

    Advice and views would be gratefully heard in consideration of this sticky issue!

  4. #4
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    The main question is how does the PI effectively delegate duties and oversee those people, if the PI is not familiar with them and has no direct (& frequent) access to those people? The answer would seem to be self evident. As per the previous answers on this forum, the PI must be able to effectively delegate duties, she does not intend to conduct herself, to suitably qualified, educated, experienced and trained individuals and to supervise those duties.

    When the PI has a sub-investigator at another site these are sometimes called "satellite sites". Advice from inspectors, is often that it is better for each site (or separate research team) to have a PI, so that they can adequately delegate and supervise. If the PI does operate satellite sites, then there is more effort required in being able to document adequate delegation and oversight. I am not familiar with any regulations or guidance that says that an Institution cannot have more than one PI, in fact I have seen many PIs operating in the same hospital with different clinical teams. The "clinical site" in this case, is each separate clinical team.


    The FDA has issued its final guidance on investigator responsibilities (Guidance for Industry; Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, Oct 2009) in which it emphasizes the PI role in active oversight of all sites used. The FDA’s states that “the following factors may affect the ability of an investigator to provide adequate supervision …: Conducting a study at multiple sites under the oversight of a single investigator, particularly where those sites are not in close proximity” and “Conducting a study from a remote (e.g., off-site) location.”
    Specifically the guidance requires that: - “for each study site, there should be a distinct individual identified as an investigator [PI] who has supervisory responsibility for the site…. and the sub-investigator should not be delegated the primary supervisory responsibility for the site.” The FDA is clear that the sub-investigator should not perform the PI specific duty of delegation and supervision of the investigator sites.

    Any records obtained and retained at this facility would be subject to monitoring, audit and inspection. The satellite staff must be adequately trained to perform whatever study work they are responsible for doing and should have those roles delegated to them by the Principal Investigator. Depending on what is being done, the informed consent process may need to be performed at the satellite site; therefore the staff must be fully trained and have knowledge of the protocol in order to address any subject concerns and questions. It is important to remember that informed consent should be gained from the potential subjects before any study related screening is performed. In addition special attention should be paid to the satellites site’s compliance with:- medical oversight of subjects; adequacy of training and availability of information such as the Investigators Brochure (& safety letters) and protocol (& amendments); documentation of site staff qualifications; blind break procedures; disposition and care of trial medication; retention of records; etc.


    The MHRA has proposed guidance (GCP Guide 2012) for specialist departments performing specific, technical tasks delegated by the PI. This refers to situations where a risk assessment has been performed and in cases where "for most members of staff this will not be any different to their normal duties".
    "Large departments (for example, pharmacy, clinical laboratories or chemotherapy units) may have activities delegated by the PI to a named person (for example, clinical trials pharmacist or ward sister) who would then take responsibility for the conduct of that activity by the department. Investigators and these delegates should perform a risk assessment to determine the training requirements for the trial in relation to the tasks to be performed. For example, a dialysis unit may be involved in a number of trials, where almost all staff are involved in the care of the subjects whilst on the trial. For most members of staff this will not be any different to their normal duties when subjects come in for dialysis. It may not be practicable to provide large numbers of staff with detailed training in the protocol, or to restrict care to a small number of staff who have received this level of training, as this may be unfeasible for the subjects and the effective running of the department. In these cases it may be appropriate to include GCP training as part of the standard induction training for that role/department, thereby ensuring that all staff have a level of GCP training".

    It is not known if other Regulatory Authorities would accept this type of delegation model.

    As stated before, the PI is totally responsible for delegation and oversight of duties, not the sub-investigator.

  5. #5
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    I can see where the confusion may have arisen regarding the assertion that there can only be one PI per institution.
    According to UK HRA NRES REC SOPs – Version 5.1 March 2012, section 4.7 states:- " There should only be one Principal Investigator at each site".

    However later sections of the SOP make it clear that if the two clinical teams are working independently of each other, then the guidance says that the individual teams may be separately identified as research sites and have a PI each. What you described seems like this.

    Section 4.15 "where the research is to be conducted in two or more entirely discrete operating units within the same NHS organisation, these units may be separately identified as research sites. Each site should have its own Principal Investigator who is accountable for the whole research team. There should be no dual accountability or overlap between research teams".

    Also for GPs, section 4.16:- "In some cases, two or more independent practices may be conducting the research within the same health care centre. These practices should normally be identified as separate research sites".


    I hope that helps.

  6. #6
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    I can see where the confusion may have arisen regarding the statement that " it is one institution there can only be one PI" . According to UK HRA NRES REC SOPs – Version 5.1 March 2012, section 4.7 states:- " There should only be one Principal Investigator at each site".

    However later sections make it clear that if two clinical teams are working independently of each other, then the guidance says that the individual teams may be separately identified as research sites and have a PI each. What you described in your question, seems like a similar scenario where the PI "has never met or worked with" the staff of the other unit and the trial "is open across two separate clinical units".

    Section 4.15 of UK HRA NRES REC SOPs – Version 5.1 March 2012: - "where the research is to be conducted in two or more entirely discrete operating units within the same NHS organisation, these units may be separately identified as research sites. Each site should have its own Principal Investigator who is accountable for the whole research team. There should be no dual accountability or overlap between research teams".
    Also for GPs, section 4.16 states:- "In some cases, two or more independent practices may be conducting the research within the same health care centre. These practices should normally be identified as separate research sites".

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