Regulatory Binder

Investigators are required by Northwell Health research policy (GR042 Human Subject Research Regulatory Binder) to maintain essential regulatory research documents in an organized fashion, which can be contained within a paper or electronic based regulatory binder whenever consent will be obtained from participants. The following forms and templates may be used and/or modified to create and organize regulatory binders for research studies. Investigators may choose to use a sponsor-provided binder, but should compare the sections to this binder and add any relevant sections that are missing. The Office of Research Compliance and the Human Research Protection Program have provided these templates and tools to promote increased adherence to good clinical practice (GCP), which applies to all clinical research protocols within Northwell Health. GCP is a standard by which research studies are designed and conducted to ensure that data is scientifically valid and the rights of human subjects are protected.

Creating Your Regulatory Binder

Hard Copy Binder: Create tabs for each section listed below and place the appropriate documents in each corresponding section in a binder. Be sure to label the outside of the binder (cover and spine) with the protocol number, PI name, and study site. Use multiple binders or master binders to maintain documentation if needed.

Electronic Binder: If maintaining a binder electronically, ensure that the documents are organized and can readily be accessed by the research team and reviewed during an audit or monitoring visit.

All sections are required unless otherwise indicated.

1. Monitoring Log

All Northwell Health IRB approved studies are subject to routine audits by the Office of Research Compliance and may also be reviewed by external entities such as the study sponsor, monitors/auditors or government agencies.

Auditing and Monitoring Log (Auditors should sign this log during every visit).

2. Delegation of Responsibilities Log

This section should include a log that lists all personnel involved in the research study, their delegated roles and responsibilities, signatures, initials, and IRB approval dates.

Delegation of Responsibilities Log

3. Study Personnel Education

All personnel involved in research with human subjects must complete the following:

  • CITI Course on the Protection of Human Research Subjects
  • CITI Course on Good Clinical Practice (for sponsor-investigator IND/IDE studies)

Click on Required Training for tutorial access and further guidance.

This section should include educational completion dates of all research staff, completion certificates, research registration forms, and other relevant documents. Successful completion dates of these mandatory requirements are available online and updated monthly.

Study personnel education and training should be tracked. When adding personnel to the study, they must complete all of the above and their addition must be IRB approved prior to participating in the study.

Note: If this information is kept in a master binder, place a note to file (in this section) referencing the location of the separate binder.

4. CVs/COIs/FDA Forms

This section should include:

  • Curriculum Vitae (signed & dated with the last 2 years) for all investigators and professional licensure (including DEA if applicable) for all clinical investigators
  • External Interest (COI) disclosure for anyone involved in the design, conduct or reporting of research. This should be completed prior to participating in research, annually and updated within 30 days of any significant new interests. External interest disclosures should be tracked for research team members. A tracking sheet can be used and filed in this section that includes dates of completed disclosures. Disclosure forms should be readily accessible. See the External Interest Disclosure page for more information.
  • FDA Form 1572 only when:An investigator-initiated study involves an investigational drug
  • OR the study sponsor requests it
  • FDA Form 1571 for investigator initiated INDs
  • FDA Part 11 Compliance Memo regarding the use of electronic signatures by Northwell employees
  • FDA Forms are available on the www.fda.gov web site

Note: If this information is kept in a master binder, place a note to file (in this section) referencing the location of the separate binder.

5. Screening/Enrollment Log

This section should include a log of subjects who were screened, screen failures, enrolled, withdrawn, and completed the study.
Reminder: Screening logs with PHI that include screen failures or subjects who have not signed consent should not be sent to external study sponsors.

Screening/Enrollment Log
Subject Identification Log

 6. Consent Forms & Enrollment Notes

This section should include consent form document(s) with any accompanying enrollment notes (all IRB approved and stamped versions) stored in reverse chronological order with the current approved version first.

Sample Enrollment Notes: Research policy on informed consent requires enrollment notes to be written to document the consent process for each subject, signed and dated by the individual completing the note. It should also include circumstances related to the subject’s ability to provide consent (e.g., capacity assessment, assent of minor, consent translation, use of a LAR, consent quiz completion, etc.). See sample templates that can be customized to your study:

Note: Any changes to the consent form must be submitted to and approved by the IRB prior to use. If you do not anticipate enrolling subjects who are not fluent in English and there is no translated consent form available, the short form should be used. Otherwise a consent form should be translated if you anticipate enrolling a Limited English Proficiency population. Short forms are available online in a variety of languages.

7. Completed Consent Forms

Place all original completed consent forms in this section. For studies that enroll many subjects, consent forms may be kept in a separate binder with a note to file (in this section) referencing the location of the separate binder.

Note: Consent forms for subjects who enrolled (signed consent forms) but later withdrew from the study must still be kept. A note to file should be written explaining the withdrawal. This note can be kept with the consent form.

8. Protocol

This section should include all IRB protocols and amendments (all IRB approved versions), stored in reverse chronological order with the current approved version first.

Note: Any changes to the protocol must be submitted to and approved by the IRB prior to implementation.

9. IRB Committee Information

This section should contain the most current IRB roster. For more information on the Northwell Health IRB roster and FWA please visit the HRPP website.  For external IRBs please contact their office to obtain an updated IRB roster.

10. Initial IRB Approval

This section should include copies of the original IRB application/submission, IRB review response to the PI, PI response to the IRB, IRB approval letters (contingent and final approval), and all relevant correspondence with the IRB (including emails)

Contact the IRB for a copy of any missing documents.

11. IRB Correspondence

This section should contain correspondence with the IRB over the lifetime of the study (other than the initial IRB submission, which has its own section) including: IRB approval letters, modification, progress reports, DSMB report, and any other correspondence.

Documents should be stored in reverse chronological order with the most current documents first. The IRB approval letter should be placed on top of accompanying forms and correspondence as a packet.

Note: If you are the coordinating site, you should retain a copy of the other participating sites’ IRB approvals.

Contact the IRB for a copy of any missing documents.

IRB Submission Log

12. Study Termination

If your research study is being terminated or if the PI is leaving and the study will no longer be continued, the IRB Termination Report needs to be completed and submitted to the IRB. This section should include a copy of the Final Report filed via InfoEd and the IRB letter acknowledging study closure.

13. Reportable Events

This section should include correspondence relevant to the issue and copies of the following documents stored in reverse chronological order with the most current documents first:

Please review the HRPP policy on when to report certain events.

Reportable events include unanticipated problems, SAEs and protocol deviations and exceptions.

Unanticipated problems are:

1) unexpected, 2) related/possibly related, and 3) may cause risk of harm to the subject or others.

For minor protocol deviations, use the Protocol Deviation Log and report to the IRB at the time of continuing review.

 14. Registration of Applicable Clinical Trials

All research studies that meet the definition of a clinical trial must be registered at www.clinicaltrials.gov as per the International Committee of Medical Journal Editors (ICMJE), the FDA Amendment Act of 2007, and Northwell Health policy.

Applicable Clinical Trials generally include controlled interventional studies (with one or more arms) or drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves, a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).

You should err on the side of registration if you wish to seek publication in and ICMJE journal. The FDA and NIH encourage registration of ALL trials. Always check clinicaltrials.gov to confirm that your study and specific study site are registered.

The PI is ultimately responsible for meeting registration requirements, especially for investigator initiated trials or where he/she holds the IND or IDE. If your study is externally funded or sponsored you should check with the sponsor or program officer. If the sponsor does not intend to register the trial, you must register it online.

If you do not already have an account, contact please contact Amanda Galvin, Clinical Trials Office516-881-7033 or Agalvin@northwell.edu. to receive log in information.

Place the registration receipt in this section for initial registration and for any updates.

15. Advertising/Educational Materials (if applicable)

This section should include: Any IRB approved advertisements, recruitment flyers, written educational, or other materials provided to study participants, stored in reverse chronological order with the most current documents first.

Note: For marketing materials used to recruit through mass media (e.g. newspaper, TV, radio, some internet postings, & etc.) you must contact the Northwell Health Marketing Department to ensure logo/branding is appropriate.

16. Sample Tracking and Shipping (if applicable)

This section should include a master log that allows tracking of research sample collection, shipment (or transport), and storage, and packing and shipping training certification (from Saf-T-Pak or other approved equivalent program).

Shippers or receipts can be placed in this section or in individual subject files.

Note: All biological materials must be handled, stored, and shipped in compliance with FAA and IATA regulations as well as Northwell Health policies on hazardous materials.

Saf-T-Pak training is available at the Center for Learning and Innovation.

17. Local Lab Certificates/Reference Ranges (if applicable)

For every certified laboratory utilized in your study that will be performing specimen testing in which results are validated (not experimental), place a copy of the most update lab certificate(s) and reference ranges. A copy of the lab director’s CV is required for experimental laboratories or if required by the study sponsor (for certified or experimental labs).

For studies that use Northwell Health laboratories, you may contact the Core & Hospital Lab at (516) 719-1100.

Note: Lab tests used to inform participants or their healthcare providers to alter care must be performed in a CLIA certified lab, or if in NY, by a NYS Department of Health certified lab.

18. Investigational Product Information (if applicable)

For studies that involve administration of investigational drugs, this section should include the Investigator’s brochure(s) (IB) (or equivalent information for investigational products), product information and package insert (or equivalent for approved medications), or device information sheet, stored in reverse chronological order with the most current version first.

A separate binder should be maintained for investigational product accountability (at the pharmacy or with the responsible individual). Useful tools are available on the Tools and Guidance for Clinical Research Website. 

19. Sponsor Correspondence (if applicable)

Please document and maintain all correspondence with the sponsor in this section.

20. Other

Place other important study documents in this section. This can include: Certificates of Confidentiality, literature or publications, reviewing committee correspondence and approvals, correspondence from the FDA, NIH, & etc., and other general correspondence.

21. Quality Assurance Tools

The following section includes useful tools you may use to assist with the informed consent process, organizing your research study, or for auditing purposes.

Audit Tools: All Northwell Health research studies are subject to routine audits by the ORC and may also be reviewed by external entities such as the study sponsor or government agencies. We recommend that sites perform self-assessments regularly and prior to audits. Included in this section:

Study Tools and Templates:  You can modify these tools and templates to conform to your study.

Subject File Templates:

Logs:

We’d like to hear from you. If you have suggestions, comments, or questions about this regulatory binder, please contact orc@northwell.edu or irb@northwell.edu.