Who should be on a delegation log?
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.)
Is a delegation log required?
There is no FDA Requirement that sites must have a Delegation of Authority Log.
Who is responsible for the delegation of duties log?
The PI/IoR
The PI/IoR retains the overall responsibility for the conduct of the clinical trial, including delegated duties/ tasks. CRS staff and other individuals will not perform study-related duties/tasks before they complete training.
Can a delegation log be signed electronically?
Electronic signature is acceptable. The date of PI signature serves as the start date for each individual listed to begin performing delegated research tasks.
What is the purpose of a delegation log?
Purpose: To record all study staff members’ significant study-related duties. Details: This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the Principal Investigator.
What is a screening log?
A Screening Log is a log which is shared with an outside entity (usually the sponsor) that would include potential subjects who have not yet signed a consent form. Some sponsors also have documents they call enrollment logs.
Does the FDA require a delegation log?
Q: Are principal investigators (PIs) required to be listed on and delegated tasks in a delegation of authority (DOA) log? A: DOA logs are not required by FDA regulations and are not discussed in FDA guidance documents for CIs.
What is delegation log in clinical trials?
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.
What is a trial delegation log?
Delegation Log A list of appropriately qualified and trained persons to whom the Principal Investigator has delegated significant study-related duties and functions. The Log details related duties and documents which study-specific roles and responsibilities are assigned to each staff member on the study team.
What is a delegation log in research?
What is an enrollment log?
The Subject Screening/Enrollment Log documents, tracks and follows the progress and status of each potential subject through the study process.
What is required to study enrollment?
While an investigator may discuss availability of studies and the possibility of entry into a study with a prospective subject without first obtaining consent, informed consent must be obtained prior to initiation of any clinical procedures that are performed solely for the purpose of determining eligibility for …