ICTR DDRS: Regulatory Records Checklist Template
Version 1.0
REGULATORY RECORDS CHECKLIST
Instructions: Review your research records and check that your records have each of the following items to ensure proper documentation of your
human research regulatory records. Examples of the documents typically maintained in an investigator’s regulatory records to each checklist item are
indicated in italics. Best practices for maintaining the specific checklist item are indicated by a star ( ).
Regulatory Records checklist for IRB approved human research activities
 Participants’ research-related records
Examples: case report forms(CRFs), laboratory results, surveys, questionnaires, sign & dated informed consent forms
Maintain one binder or file per participant
 Protocol and study instruments
Examples: each IRB-approved version of the protocol, CRFs, surveys, questionnaires, etc.
Maintain IRB-approved protocol version (and associated instruments in reverse date order in your regulatory binder
Consider placing the most recent, valid IRB-approved Protocol (and associated research tools) in a separate red folder from previous
versions
 Informed consent process documents
Examples: Informed Consent Form, Parental Permission Form, Proxy Informed Consent Form, Assent Form
Maintain IRB-approved informed consent/assent versions in reverse date order in your regulatory binder
Place the most recent, valid IRB-approved informed consent/assent documents in a red folder separate from all previous versions
Document the time of consent directly on the consent/assent document or include a “Note to File” in the medical or research record, when
the informed consent process and research intervention occur on the same date
 IRB Correspondence
Examples: letters of IRB approval of the initial application, modifications, renewal requests; and acceptance of reportable events
(unanticipated problems and adverse events)
You might consider filing all correspondence with the IRB in reverse data order in your Regulatory binder—this will give you an at-a-glance
method for determining your approval status
 Reportable events documents
Examples: letters regarding any event that is defined as reportable by your IRB and, if applicable, the study sponsor and/or FDA such as
unanticipated problems (events) involving risks to participants or others (defined by the IRB, sponsors, and the FDA)
You might consider filing correspondence with the IRB in reverse data order in your Regulatory binder—this will give you an at-a-glance
method for determining your approval status
 Participant Screening Log or equivalent
 Current Principal Investigator Curriculum Vitae
 Key Personnel List
 Education Certification documents meeting JHM IRB training requirements
Examples: Copies of Human Subjects Research training certificates for each study team member involved in the conduct of human research
activities; copies of curriculum vitae for each team member obtaining informed consent from study participants
ICTR DDRS: Regulatory Records Checklist Template
Version 1.0
Regulatory Records: All FDA-Regulated Studies (drugs, devices, biologics)
Regulatory Records:
 Correspondence
Examples: Sponsor notifications/letters to the PI: requests for information; site approval letters; updated protocols; notifications of site visits;
grant/funded proposal; contract with the PI/institution
Sponsors often provide the PI with a pre-organized Regulatory Binder, participant visit CRFs, and other tools to facilitate record keeping. Use
them.
 Sponsor Monitoring Logs/Reports
 FDA Correspondence
Examples: letters of between the FDA and the investigator
 Participant Screening Log
 Test Article Accountability Log
 Laboratory Certifications (if using a laboratory)
Examples: copies of current laboratory certifications for all laboratories involved with the study present or, if the study is a multi-center study,
certifications for all laboratories used for locally enrolled participants’ specimens
 Range of Normal Values (if blood work required by the protocol)
Example: Laboratory analyses for all blood work required by the IRB-approved protocol must include the range of normal values
Regulatory Records: All FDA-Regulated Studies with an IND (drug studies ONLY)
 Form FDA-1571: Investigational New Drug Application (if investigator is also the study sponsor and
holds IND)
For IND ONLY: Is the monitor listed in section 14 of Form FDA-1571 the person monitoring the study for subject safety and
protocol adherence according to the protocol’s data safety and monitoring plan?
 Form FDA-1572: Statement of Investigator (all IND studies)
 Investigator’s Brochure (or equivalent)
Example: copy of each IRB-approved version of the IRB-approved Investigator’s Brochure
Regulatory Records: FDA-Regulated Investigator-Sponsors (PI holds the IND/IDE)
 FDA letter of no objection
 IND/IDE amendments
 IND/IDE Annual Reports
 Safety Reports
Example: MedWatch Reports