A Delegation of Authority Log documents which study-related activities the investigator has delegated to which individuals or entities. There is no uniform official German term for this document; in practice, it is often referred to as a delegation list or a Delegation of Authority Log.
Purpose and Minimum Content
The investigator may delegate suitable tasks to qualified individuals, but remains responsible for the proper conduct at the study site. ICH E6(R3) requires documentation of the individuals and parties to whom the investigator has delegated study-related activities. This documentation clarifies who performs which role and whether the task was assigned to the person with sufficient qualification and under appropriate guidance.
A practical delegation list therefore names at least the person or entity concerned, the delegated activity, the period of assignment, and the confirmation by the investigator according to local requirements. It is promptly updated in case of personnel changes or altered responsibilities. Additionally, qualification and training documents are essential records at the study site. The log does not replace these records but links the specific activity to the responsible and qualified person.
Proportionality according to ICH E6(R3)
ICH E6(R3) explicitly emphasizes the significance of the study-related activity. The documentation of delegation should therefore be proportionate. This means that not every supportive action automatically becomes an entry on the delegation list. The crucial factor is whether the activity is relevant to the clinical trial and who performs it responsibly. Proportional design does not relieve the investigator of the responsibility for selecting, instructing, and supervising the involved individuals.
An important clarification concerns activities that occur within the scope of normal clinical care. In such cases, delegation documentation may not be necessary. This is not a blanket exception for the study site. Rather, the distinction requires a reasoned consideration of the respective task, the study protocol, and the local organizational structure. Where study procedures or study-specific data collection are involved, a traceable assignment remains regularly essential.
Distinction from Service Provider Contracts and Related Entries
The Delegation of Authority Log documents the distribution of tasks at the study site under the investigator’s responsibility. It is not a contract between the sponsor and CRO or another service provider. Such a contract describes the transfer of sponsor tasks or external services, while the delegation list records which individuals at the site are permitted to perform tasks such as informed consent, visits, documentation, or investigational product management. Both documents may concern the same study but cover different areas of responsibility.
Also, the principal investigator, the study coordinator, and the study site are not synonyms for the Delegation of Authority Log. The investigator bears the responsibility, the study coordination can perform assigned operational tasks, and the study site is the organizational environment for the conduct of the study. The log creates transparency regarding their specific task distribution. A signature log or training documentation can supplement, but does not necessarily replace, the assignment of delegated activities.
The list is not merely a personnel overview. It should reveal the relationship between task, suitability, and responsibility. Therefore, when reviewing the log, it must also be questioned whether the person actually performs the documented task and whether the task is appropriate for their role. If services are provided centrally by a laboratory, pharmacy, or another department, it should be clear whether it is a delegation by the investigator, a service regulated by the study protocol, or normal clinical care.
Relevance for clinical trials
During monitoring, auditing, and inspection, an up-to-date delegation documentation helps to trace the path from a study task to the person actually performing it. Typical deficiencies include a lack of updates after personnel changes, unclear roles, undocumented qualifications, or entries that do not match actual practice. Especially with multiple departments, outpatient areas, or changing personnel, a clear list prevents tasks from being performed without identifiable responsibility.
Full-service CROs like Mediconomics assist with setting up site-appropriate templates, reviewing qualification and training documents, monitoring timeliness, and filing essential documents in the investigator site file. They can clarify open responsibilities with the study site and sponsor, track personnel changes, and translate findings from monitoring visits into agreed corrective actions.
Frequently Asked Questions (FAQ)
Is “Delegationsnachweis” an officially defined German term?
There is no uniform official term. Here, it describes the document commonly referred to in practice as a delegation list or Delegation of Authority Log.
Do normal patient care activities always have to be included in the delegation list?
No. ICH E6(R3) allows for delegation documentation to be omitted if the activity is part of clinical practice. The significance and study relevance of the specific activity are decisive.
Does the Delegation of Authority Log replace the contract with the CRO?
No. It documents the investigator’s delegations at the study site. The contract with the CRO or another service provider governs a different relationship and different tasks.
Regulatory References
- ICH E6(R3), Section 2.3.3 – Documentation of delegated tasks and the principle of proportionality.
- ICH E6(R3), Section 2.3.1 – Investigator’s responsibility for delegation to suitable individuals or parties.
- ICH E6(R3), Section C.2.3 – Essential documents in investigator and institution repositories.
- EudraLex Volume 10, Chapter V, Sections 3.1.10 and 3.3 – Qualification documents and retention of delegated essential tasks.
