Keep your study files organized and always ready for inspection. Be sure to include the following, if they apply to your study:
ALL correspondence with the sponsor, IRB, monitors, and study subjects
Letters, faxes, e-mails, memos, and documentation of telephone calls (date/summary of call)
Screening and/or enrollment logs
Test article accountability records are usually stored by Tufts Medical Center Investigational Drug Services (IDS) / research pharmacy: Shipping receipts, dispensation logs, and drug accountability logs
Standard operating procedures (SOPs)
Documentation of the training, expertise, and experience of the research team, as well as job descriptions (and/or delegation of authority logs) and CVs/resumes
Executed (signed) informed consents for enrolled subjects
Document communication and decisions using memos-to-file.
Carefully document what happens during your research study so all relevant information is in the study file (so your study files tell the story of what happened in your research study).
Scheduling the Inspection
Sometimes Inspections are not scheduled in advance, but when an inspection is scheduled, you can prepare:
When you receive a phone call (for example from the FDA) to schedule an inspection, ask for:
The Inspector’s name
The Inspector’s contact information
The study (or studies) to be inspected
The reason for the inspection
What records will be needed
The start date of the inspection
The anticipated length of time of the inspection
Reserve a work space for the Inspector (preferably away from study file storage and work areas –an empty office with a table or desk that has access to telephone/internet and is close to a copy machine).
Notify: The PI, Co-Is, and research team; Department Chair/Division Chief; Research Administration/Institutional Official; the IRB office; Research Pharmacy; the study Sponsor.
Familiarize yourself with the details of the study being reviewed, including:
The IRB’s requirements
Adverse event reporting requirements
The protocol, including eligibility criteria, study windows, and study procedures
Each research team member’s roles and responsibilities
Have ALL study materials available for inspection (including regulatory and accountability records, case report forms, monitoring reports, and source records).
Consider whether you would like to flag important items that you can anticipate the Inspector will want to see, such as IRB approval letters. For example, consider creating a timeline for IRB review and approval with corresponding flags in the study files. Consider whether it would be feasible and beneficial to create a timeline with corresponding flags for each subject.
During the Inspection
Remain calm, listen carefully, take notes, be professional, & utilize resources and expertise.
When the Inspector arrives:
Ask the Inspector to please show you identification, then read the identification they provide, match it with the name provided to you when the inspection was scheduled.
Walk the Inspector to the identified work space, point out the restroom and telephone.
Ask the inspector to explain how the inspection will work, for example, what time the Inspector will arrive and leave each day, what is being inspected, what materials will be needed, who will the Inspector want to speak with (and what time).
Request an end-of-day de-briefing (a meeting to go over findings at the end of each day).
Arrive before the Inspector each day – ensure the designated space is in order.
Arrange to escort the Inspector to the work space each day, especially if the Inspector will be walking through work areas to get to their work space.
Keep in mind:
All discussion with the Inspector is official.
The Inspector might ask questions more than once.
Answer the question being asked (avoid elaborating and unnecessarily explaining beyond responding to the question being asked).
If the Inspector asks you a question and you aren’t sure you understand what the question is, you could say something like “I want to be sure I fully understand what you are asking, could you re-phrase the question?”
Don’t guess when answering questions. If you don’t know the answer to a question, you should not be the person who responds to that question. You could say something like “This is not within my scope of responsibility, but let me direct you to the best person to answer that question.”
Do not offer FDA inspectors food/lunch.
Hold discussion with your staff at the end of each day, review questions or notes left, as this may predict the focus for the next day.
Critically review any errors or issues identified during the inspection, and develop a detailed corrective and preventive action plan that will correct and/or prevent these errors and issues from happening in the future.
Complete and Distribute to Your Research Team for Easy Reference in Case of an Unannounced Inspection
Notify the following people/groups about the inspection, as applicable:
Department Chair/Division Chief
Research Administration / Institutional Official
IRB office (ext. 6-7512)
Tufts Medical Center Investigational Drug Services (IDS) Research Pharmacy
Locate an inspection space (list your first choice first, and then alternate spaces in order of preference): Office/Conference Room, Contact Person to reserve room, Contact Person’s telephone #
Use these checklists to conduct routine quality assurance inspections of your study files: