1. Managing Regulatory Documents Electronically
Adrienne Meyer, CIP
Regulatory Specialist
Institute of Translational Health Sciences
Research Coordinator Networking & Education Day
May 17, 2013

2. Goals and Contents Describe regulatory binders
Describe things to consider when developing and implementing an electronic regulatory binder
Demonstrate a simple system for electronic binders
Questions and Discussion

3. What is a Regulatory Binder?
Originates from the conduct of clinical trials – FDA regulated, e.g. IND or IDE
Synonyms: investigator binder, investigational site file (ISF), investigator files, study binder, study administrative file
Good Clinical Practice (GCP) Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.
Full List of Essential Documents can be found on the FDA’s website:

4. What is a Regulatory Binder?
Essential Study Documents which are NOT patient specific are organized in a Regulatory Binder
It is often the first document reviewed during audits and inspections.
A complete regulatory binder provides documentation to support that the investigator adhered to his or her responsibilities under federal laws and guidance for conduct of human subjects research.

5. What is a Regulatory Binder
The collection of paper documents under pre-specified tabs is a convention NOT a stipulation of GCP. “Regulatory Binder” is simply a place where we organize and store and update regulatory documentation

6. What kinds of documents should be in a regulatory binder?
Depends entirely upon the nature of the research
Involves Human Subjects?
a. Current and Past Protocols/Standard Operating Procedures/Manuals of Operation
b. IRB approvals and correspondence
c. Current and Past Versions of Consent Forms and other Authorizations
to be signed by Subjects
d. Documentation of Investigator and Staff Training
e. Sponsor required documentation
Involves Labs?
CLIA and CAP certifications
Current and Past Lab Normal Ranges
Drugs and Devices?
Past and Present Investigator’s Brochure
Device Manual
FDA Form 1571/1572
Subject Screening and Enrollment Logs
Adverse Event and Protocol Deviation Logs
Monitoring and Site Visit Logs
Delegation of Responsibility Log
Curriculum Vitae and Licenses
Sponsor Correspondence
Other Approvals
Radiation Use Committees
Institutional Approvals
For more specifics including a checklist and downloadable templates, see our resource page:

7. Thinking electronically
Many of these documents are retained as copies at the investigational site
UW has been directed by the legislature to reduce paper consumption by 30%

8. Show and Tell
Why not e-copies instead of paper copies?

9. Getting Started Come up with a plan
Are you starting from scratch with a new study or are you converting existing paper documents into electronic?
What will you NEED to keep in paper?

10. Security & Technology
How large are your files? Do you have enough storage space?
Is your system secure? Is it backed up regularly? Is it in danger of disappearing or changing in the foreseeable future.
Is it accessible to key study personnel?
What format will you use? Will it be readable in the future? Archivable?
Can you put procedures in place for providing access to the electronic regulatory files at the time of a visit by a monitor or auditor.
For example: if documents are copied to a CD or DVD for a monitor’s visit, can you test the CD or DVD to make sure the documents were copied successfully and completely?

11. Institutional Requirements?
Records belong to the institution, not necessarily the sponsor or the investigator
At UW – It’s the state’s property and public records to boot!
Specified and required order and content?
UW has none, but others may – VA folks?
What file types are acceptable?
Contact your records management office!

12. Tips and Tricks Minimize the use of paper at its source
Does that really need a signature?
Do I really need to keep this in paper?
Describe your documentation process in your Standard Operating Procedures or Manual of Operations!
Develop naming conventions so that the contents of each file and document are apparent when viewing the labels. Any appropriate and easily understandable labeling convention is fine. Examples:
Limburg_medlic_x21Jan2010
Limburg_CV_02Feb2009
Limburg_HSP_x10Jul2010
Keep study closure and long-term record retention in mind when developing your system.

13. Tips and Tricks
Place a paper placeholder in the relevant location of the binder that directs an individual to the electronic location OR place a paper placeholder in one location in the binder that includes a list of all documents that are stored only in electronic format, along with the specific electronic path for each item.
Develop support materials for your monitors and auditors.

14. General good practices applicable to both paper and electronic
Tailor the binder to meet the needs of your specific protocol
Unless required by your institution, Include only sections pertinent to your protocol.
Organize and order the sections to facilitate easy use and reference
Add additional folder and/or documents to each section as needed.
Keep the Regulatory Binder current and up-to-date.
Identify an individual(s) responsible for maintaining the binder. Ensure that this person is on file with the IRB as an Additional Person to Contact to ensure that all IRB correspondence and documents are received/filed in a timely manner.
Store binder in a safe and secure location, but accessible to study staff at all times.
Participant-specific documentation and information, e.g., signed consent forms, test results, and completed case report forms, should be maintained separately in participant-specific binder/file.
The Regulatory Binder may sometimes consist of several folders that are stored in the same or different locations. It is important to know where all these documents are located to be able to pull them out when needed in a timely manner.

15. Thanks and Credit! Thanks to Phase I Medical Oncology group at SCCA!
Bojana Askovich
Reina Hibbert
Jamie Williams
Thanks to Christine Taylor of UW Medicine Records Management!
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