Quality Assurance Menu
ORP Menu
Regulatory Binder – Document Checklist
Regulatory binders are used to organize and maintain research study documentation including all regulatory documentation, such as ORHP requirements[1], FDA regulations[2] and documentation guidelines for good clinical practice (GCP)[3]. Although study teams at Penn State have the CATS IRB system to track their IRB protocols and documentation related to human subjects research, CATS IRB is not intended to store all regulatory documentation. Having a regulatory binder can help any researcher meet regulatory requirements and establish a high standard of record-keeping for human subjects research.
A regulatory binder can be physical or electronic copies of the necessary documentation. If keeping electronic copies, organize files within electronic folders for a specific study. Although the regulatory binder is especially beneficial for research subject to regulations beyond the IRB, maintaining a regulatory binder of pertinent IRB information, such as notes to file, study team member training and study procedures applies to all studies.
A binder can help basic science and clinical researchers to
- Create a longitudinal archive of the study
- Maintain regulatory compliance
- Promote transparency
- Promote accountability
- Document safety monitoring
[1] 45 CFR 46 at http://ohrp.osophs.dhhs.govwith the standards of Good Clinical Practice and with all applicable regulatory requirements
[2]21 CFR 11, 50, etc. at www.fda.gov
[3] ICH/GCP at www.ich.org
The following is a checklist of documents (all versions) that should be collected and filed in the regulatory binder, if applicable to the clinical study.
| Section | Required Y or N/A | Document |
|---|---|---|
| Protocol, Procedures and Amendments | Yes or N/A | Log of protocol changes |
| Protocol, Procedures and Amendments | Yes or N/A | Institutional Review Board (IRB)-approved protocol |
| Protocol, Procedures and Amendments | Yes or N/A | IRB-approved recruitment materials |
| Protocol, Procedures and Amendments | Yes or N/A | Study Standard Operating Procedures (SOPs) |
| Informed Consent Documents | Yes or N/A | Log of Informed Consent versions |
| Informed Consent Documents | Yes or N/A | IRB-approved Informed Consents* |
| IRB Approvals and Correspondence | Yes or N/A | IRB approval letters (e.g., initial submission, continuing review and modifications) |
| IRB Approvals and Correspondence | Yes or N/A | IRB correspondence (emails/conversations not recorded in CATS IRB) |
| IRB Approvals and Correspondence | Yes or N/A | IRB-approved documents |
| Study Communication | Yes or N/A | Letter of Understanding/Confidentiality Agreement |
| Study Communication | Yes or N/A | Data Sharing Agreement |
| Study Communication | Yes or N/A | Material Transfer Agreement |
| Study Communication | Yes or N/A | Signed agreements between parties (i.e., sponsors/investigators) |
| Study Communication | Yes or N/A | Important decisions regarding study conduct, such as notes to the Study File |
| Study Communication | Yes or N/A | Notes to File |
| Screening/Enrollment Log | Yes or N/A | Screening/Enrollment Log |
| Screening/Enrollment Log | Yes or N/A | A log without identifying information that lists all screened subjects |
| Screening/Enrollment Log | Yes or N/A | Subject Identification Code list (which should be kept separately) |
| Signed Consent Documents (may be kept in a separate binder) | Yes or N/A | Study Product Records (documentation of study product and accountability forms/logs) |
| Serious Adverse Events (SAE)/Unanticipated Problem Documents/Reportable New Information | Yes or N/A | SAE Report Forms |
| Serious Adverse Events (SAE)/Unanticipated Problem Documents/Reportable New Information | Yes or N/A | Unanticipated Problem Forms |
| Serious Adverse Events (SAE)/Unanticipated Problem Documents/Reportable New Information | Yes or N/A | IND Safety Reports (if applicable) |
| Serious Adverse Events (SAE)/Unanticipated Problem Documents/Reportable New Information | Yes or N/A | Reportable New Information (RNI) |
| Protocol Deviation Form or Memo | Yes or N/A | Protocol Deviation Form or Memo |
| Data and Safety Monitoring Documents | Yes or N/A | Data and Safety Monitoring Plan (if not included as part of the study protocol) |
| Data and Safety Monitoring Documents | Yes or N/A | Study reports generated for Independent Safety Monitor(s) |
| Data and Safety Monitoring Documents | Yes or N/A | Minutes from independent safety monitor(s) meeting(s) |
| Data and Safety Monitoring Documents | Yes or N/A | Recommendations and correspondence from the independent safety monitor(s) |
| Specimen Tracking Log (if applicable) | Yes or N/A | Specimen Tracking Log |
| Post-IRB Approval Review Reports and Corrective Action/Preventive Action (CAPA) Reports (if applicable) | Yes or N/A | Post-IRB Approval Review (PAR) Reports |
| Post-IRB Approval Review Reports and Corrective Action/Preventive Action (CAPA) Reports (if applicable) | Yes or N/A | Corrective Action/Preventive Action (CAPA) Reports |
| Clinical Site Monitoring Visits (if applicable) | Yes or N/A | Site visit log |
| Clinical Site Monitoring Visits (if applicable) | Yes or N/A | Site visit reports |
| Clinical Site Monitoring Visits (if applicable) | Yes or N/A | Site visit correspondence |
| Laboratory Certification (Clinical Laboratory Improvement Amendments [CLIA], College of American Pathologists [CAP], etc.) (if applicable) | Yes or N/A | Updated normal-range values for each reference laboratory |
| Laboratory Certification (Clinical Laboratory Improvement Amendments [CLIA], College of American Pathologists [CAP], etc.) (if applicable) | Yes or N/A | A copy of certifications or accreditations (CAP, CLIA, or state certificate) |
| Sponsor Correspondence (if applicable) | Yes or N/A | Sponsor Correspondence |
| Financial Disclosure Forms (if applicable) | Yes or N/A | Signed Financial Disclosure Forms for the PI and co-investigators |
| FDA Documents (if applicable) | Yes or N/A | FDA Forms 1571 and 1572 |
| FDA Documents (if applicable) | Yes or N/A | Sample of labels attached to investigational product containers |
| FDA Documents (if applicable) | Yes or N/A | Regulatory approval or authorization |
| FDA Documents (if applicable) | Yes or N/A | FDA Correspondence Log |
| Delegation of Authority Log (recommended for Clinical Trial) | Yes or N/A | Delegation of Authority Log |
| Clinical Research and Study Training (recommended for Clinical Trial) | Yes or N/A | Documentation of human subject protection training and Good Clinical Practice training (for all staff members) |
| Clinical Research and Study Training (recommended for Clinical Trial) | Yes or N/A | Documentation of Dangerous Goods Training (if applicable) |
| Investigator Qualification Documentation (recommended for Clinical Trial) | Yes or N/A | Updated investigator and sub-investigator CVs (signed/dated within 2 years) |
| Investigator Qualification Documentation (recommended for Clinical Trial) | Yes or N/A | A clinical (dental, medical, etc.) license for the PI and co-investigators |
| Clinical Investigator’s Brochure (recommended for Clinical Trial) | Yes or N/A | Clinical investigator’s brochure |
| Clinical Investigator’s Brochure (recommended for Clinical Trial) | Yes or N/A | Package insert; include labeling for approved medications |
| Study Product Records (may be kept in the research pharmacy to protect the blind) | Yes or N/A | Documentation of study product (e.g., botanicals, probiotics, or other natural products) disposition and accountability, or memo as to where records are located (e.g., research pharmacy) and who is maintaining accountability logs |
| Other Documents | Yes or N/A | Unmasking procedures for blinded trials |
| Other Documents | Yes or N/A | Certificate(s) of Confidentiality |
| Other Documents | Yes or N/A | Other study documents |
*Note: All IRB-watermarked versions of the consent should be kept. The CATS IRB system does not keep these on file once the form is revised.
Office for Research Protections
Address
200 Innovation Blvd.
Suite 110
University Park, PA 16802
The Office for Research Protections (ORP) ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.