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Delegation of Responsibilities

The Investigators (Chief and Principal) will be supported by a team of people who will be responsible for carrying out various task and activities (both clinical and non-clinical) on the study.   ICH GCP guidelines state that ‘each individual involved in conducting research should be qualified by education, training and experience to perform his or her respective task(s)’1.

The Investigators (Chief and Principal) are responsible for delegating out tasks on the study to appropriately trained/qualified individuals and ensuring that these individuals have the 'appropriate' GCP and protocol-specific training/supervision required for their specific roles and responsibilities (and that this evidenced on file). For some study roles it may be most 'appropriate' to tailor the GCP training so that it is specific to the individuals’ role on the study (covering aspects such as documenting activities in source notes and recording adverse events).

The sponsor is responsible for ensuring that formal processes are in place to maintain oversight of all delegated functions.  For clinical trials sponsored by a Noclor partner the risk assessment and monitor plan will be used to document these formal processes.  The sponsor may specify the level of GCP/protocol specific training required for a particular role on a study during the risk assessment process.

Training should be an ongoing process during the trial and should be documented accordingly, for example, updates to training of team when there are amendments to protocol or study procedures, new safety information (to inform study team of what to look out for), changes to legislation etc.

ICH GCP also states that ‘the Investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties’2. To satisfy ICH GCP Section 4.1.5 all clinical trials sponsored by a Noclor partner are required to establish a study-specific authorised delegation log (this is a checklist document that should be reviewed/agreed by sponsor prior to study initiation) on which each team member’s responsibilities will be documented. The delegation log should be supported by the following additional evidence on file: signed and dated CVs; evidence of contract with the host site (where required); training certificates (as relevant to role and to study), attendance and notes from study initiation (where relevant); 1:1 supervision/training (where relevant); SOP signature pages (where relevant); minutes of team meetings etc. 

The delegation log 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.  The delegation is not just a paper exercise; it is documented evidence of appropriate delegation of investigator’s responsibilities.3

The delegation log should be kept up to date at all times (real-time as demonstrates oversight), for example, when a member of staff leaves or is no longer working on the study in the same capacity this should be recorded. Delegation logs and all supporting evidence should be retained by the Chief Investigator in the Study/Trial Master File (S/TMF) for co-ordinating centre delegated activities and by the Principal Investigator in the Investigator Site File (ISF) for site delegated activities, all documents should be available for review (or provided) on request by Noclor (sponsor).

 

[1] ICH GCP Section 2.8

[2] ICH GCP Section 4.1.5

[3] MHRA Good Clinical Practice Guide (Grey Guide 2012)