The terms Essential Documents, Investigator Binder or Study Binder are sometimes used interchangeably. For all clinical research trials involving human subjects, there must be a file maintained by the Sponsor and the Investigator containing all the necessary paper work to support the clinical trial and could be called any of the above-mentioned names. During an onsite review of study records by an IMARC monitor, essential documents are reviewed to ensure that they are present, accurate, complete and current by following the ALCOA checklist and as specified in the FDA regulation 21 CFR 812.140.
One of the first documents reviewed in the study binder during a periodic onsite visit is the Delegation of Responsibilities Log. This is done to become familiarized with the study personnel, the tasks delegated by the Principal Investigator to the other study team members and the date each individual started on the study team. It also assists in setting the stage for the review of the study binder. It is a snapshot or summary of documentation that should be on file. The Delegation of Responsibilities Log is not a required document per the FDA regulations; however, it is considered an essential clinical investigation document according to the International Organization for Standardization (ISO 14155:2011(E)).
How does the Delegation of Responsibilities Log provide clues to the monitor as to what should be on file in the study records?
- Provides the names and signatures of study personnel: The log lists out the names of each individual that is participating as part of the study team. The monitor then reviews the Institutional Review Board (IRB) submission and approval letters filed in the study binder to ensure these same individuals are listed as part of the study with the IRB. The signatures of each team member can then be used by the monitor to compare to signatures found elsewhere on study documents. This will assist in ensuring that an individual on the study team is signing off on Case Report Forms (CRF) or the Device Accountability Log. (Additional information on Device/Product accountability can be found here in this previous blog.)
- Provides the role of each member of the study team: The log will designate the role of the each individual, such as Principal Investigator, Co-Investigator, Research Coordinator or Regulatory Specialist. Based on the role, the monitor would then expect to find a current medical license for an individual that has the role of an Investigator, filed in the study binder. Any Investigator participating must be qualified by training and experience according to the FDA 21CFR812.43(a). The monitor would then look for a curriculum vitae (CV), a required essential document 21CFR812.43(c)(1) for the Investigator that details the education, qualifications and professional experiences to show that he or she is qualified by experience. Additionally, one that has the role of an Investigator must also disclosure any financial interest or conflict of interest in regards to the clinical research trail as discussed in this previous blog. Financial Disclosure by a clinical Investigator is a requirement of the FDA 21CFR54 and the documentation should also be found within the study binder.
- Provides the tasks assigned to each member of the study: For every person added to the study, the Principal Investigator must indicate the start date for the individual as a study team member and designate the tasks that the individual will be responsible for throughout the study. (Remember, though, that ultimately the Principal Investigator is responsible for the conduction of the clinical trial according to 812.100). These tasks can only be designated to those members that are qualified once again by training and experience. As previously mentioned, the CV would be an indication of the experience. A study training record would demonstrate that an individual is qualified by training to be a study team member. Study specific training would generally be conducted by the Sponsor of the study. The monitor would look in the in the study binder for training records for every study team member. To take it a step further, the monitor would also review the training record for the date of training to ensure that the training took place prior to the individual being added to the study and delegated tasks by the Principal Investigator on the Delegation of Responsibilities Log.
As the Delegation of Responsibilities Log is not a required document per the FDA regulations, it is a great tool to track and summarize the people involved in a clinical research trial at a site. It can also be a good indication as to the documents that a monitor would or should find within the study binder.
What are your thoughts on the use of a Delegation of Responsibilities Log?
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