Delegation Log

What is a Delegation Log?

The delegation log is based on Good Clinical Practice Guideline of the International Conference on Harmonization (ICH-GCP) E6 (R2).

• GCP 4.1.5- The Investigator should maintain a list of appropriately trained persons to whom the investigator has delegated significant trial-related duties.

• GCP 4.2.3- The Investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

• GCP4.2.4 - The Investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product and their trial related duties and functions. 

• GCP 4.2.5-The Investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.

The delegation log MUST be completed BEFORE the delegated individual commences any study related activities. More information and training can be found here.

Who is Responsible?

• 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.

• 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)’. 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 

Top Tips

• 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.