This guidance provides information on the importance and correct usage of a study delegation log.
The delegation log is based on Good Clinical Practice Guideline of the International Conference on Harmonization (ICH-GCP) E6 (R3).
GCP 2.3.1 - The investigator may delegate trial-related activities to other persons or parties. The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data
GCP 2.3.2 - The investigator should ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties in accordance with local regulatory requirements).
GCP 2.3.3 - The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities.
The delegation log MUST be completed BEFORE the delegated individual commences any study related activities. More information and training can be found here.
The delegation log is the Principal Investigators (PI) responsibility as mandated by ICH/GCP. The PI is responsible to personally have oversight of the quality of the work delegated, tasks and responsibilities. This also extends to contracted employees and 3rd party vendors.
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, include a broader definition of eligible professionals who can be principle investigator here. Under the revised regulations, who can be an investigator has been significantly expanded and now a much broader pool of health care professional can act as investigators.
Those professionals must be registered with their relevant regulator, such as the nursing and midwifery council, general medical council and health and care professions council.
ICH-GCP guidelines state that 'Individuals involved in a trial should be qualified by education, training and experience to perform their respective task(s)'. The delegation log supports this requirement.
The tasks delegated to each member of staff must be in line with local SOP and Research Ethics Committee (REC) requirements, qualifications and training. Examples of this include obtaining informed consent, managing a site file and IP management.
The delegation log should clearly identify staff involved in medical decisions, performing study related procedures, collection and input of data, receiving consent, activities aligning to (not restricted to) Pharmacy, Laboratories, Clinical skills, Radiology etc.
The delegation is not just a paper exercise; it is documented evidence of appropriate delegation of investigator’s responsibilities
Investigators should complete the date of delegation, initial, and assign responsibilities to all staff with start and or end dates as appropriate in a timely manner.
File documentation of training in the Investigator Site File (e-ISF, ISF).
The delegation log should be kept up to date at all times (real-time as demonstrates PI oversight).
Consider the use of a training log to run alongside delegation log.