What is delegation of Authority in clinical research?
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The delegation of authority (DOA) log is a mechanism for tracking study team members over time. Those who are engaged in the research activity (including IRB approved study team members) need to be listed on the log.
Who should be on the DOA?
All staff who have been delegated any task related to the protocol should be listed on this log. This includes PI, Sub-Investigators, Research Nurses and Coordinators, Research Fellows and Residents, Regulatory Coordinators, students (medical, dental, nursing, undergraduate, etc.)
Can an investigator delegate informed consent?
While the investigator may delegate the task of administering and obtaining informed consent to a qualified individual, he or she is ultimately responsible for ensuring the process is conducted properly.
What is delegation of authority?
The delegation of authority refers to the division of labor and decision-making responsibility to an individual that reports to a leader or manager. It is the organizational process of a manager dividing their own work among all their people.
What is a master delegation of authority log?
• Master Delegation Profiles created per role and completed by personnel upon start of role. and maintained throughout time in role. • Individual Protocol Delegation of Authority logs track staff assigned to specific protocols, along with dates active on the trial in role. Outcome.
Is a delegation of authority log required?
There is no FDA Requirement that sites must have a Delegation of Authority Log.
How important is delegation of authority?
Through delegating powers, the subordinates get a feeling of importance. Delegation also helps in breaking the monotony of the subordinates so that they can be more creative and efficient. Delegation of authority is not only helpful to the subordinates but it also helps the managers to develop their talents and skills.
Why do we need delegation of authority?
Delegation of authority helps develop the capacity of others and makes them feel valuable to the organization. It also encourages job satisfaction through a sense of shared responsibility and breaks the monotony of a subordinate’s usual tasks and routine.
Who should appear in the site Delegation log?
All personnel who have been delegated significant study related duties or tasks, which the Principal Investigator would otherwise do, must be listed on the log. Information entered in all sections of the log should be legible and accurate.
What is appropriate delegation?
Appropriate delegation is primarily an issue for tasks considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing medical care to subjects during the course of the study.
What observations do GCP auditors make about delegation of responsibilities?
As GCP auditors, we always raise observations related to the delegation of responsibilities at the investigational sites. For example, when reviewing source documents, we sometimes realize that an investigator who was not delegated and who had not received training in the study protocol conducted study specific tasks.
What is delegation of tasks in clinical trials?
These items should help the investigator understand that delegation of tasks in a clinical trial goes hand-in-hand with both the responsibility to ensure adequate qualification to conduct the delegated tasks, and the responsibility to supervise the delegated individuals.
What are the major findings in GCP and regulatory inspections?
Inadequate delegation and training continue to be major findings in GCP and regulatory inspections. 1–3 ICH has added two new items (4.2.5 and 4.2.6 ) to the guideline pertaining to delegation of authority and training.