Maintenance of Human Subject Research Documents

Research related documents should be maintained by the principal investigator (PI) or his/her designee and made readily available upon inspection.  It is Northwell Health policy (GR042 Maintenance of Human Subject Research Regulatory Documentation) to maintain research regulatory documents.  The research related documents are called Essential Documents per Good Clinical Practice (GCP) guidelines.  Essential Documents are defined as the documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.

The benefits of organizing Essential Documents are:

  • Demonstrates compliance with institutional policies, as well as standards of GCP, and with all applicable regulatory requirements.
  • Easy to reference research information by the study team
  • Allows review/audit by the monitor, auditor, IRB, or regulatory authorities.

These documents can be collected and filed in paper, electronic form, or as a hybrid of both paper and electronic copies depending on the procedures set forth at each site or by the research team.

Paper Documents: Create a binder with tabs for each section listed below. Essential Documents should be filed in each corresponding section in the binder. Be sure to label the outside of the binder with the protocol number, PI name, and study site.

Electronic Documents: File documents in a secured network location, ensuring the documents are organized, and can be easily and readily accessed by the research team as well as during monitoring visits or audits. Be sure that the naming conventions are consistent throughout the documents.

Paper and Electronic Documents: If maintaining both paper and electronic copies, follow both instructions above for paper and electronic filing methods. In addition, be consistent with the methods used for filing documents and keep a record of the document locations.

Maintaining Your Research Documents

The templates (i.e., logs, checklists, notes) can be utilized to organize the documents for your research. They can be modified or created as necessary to meet the specific needs of study requirements.  The forms (i.e., FDA, SAE, etc.) should be utilized as needed.  The PI may choose to use a sponsor-guided method of filing Essential Documents, but the sections should be compared to this webpage and add any relevant sections that are missing.

All sections are required unless otherwise indicated.

1. Table of Contents

This section should have a list of all research documents filed for your research study.  It should be filed either as a table of contents or Essential Document Checklist.  If the documents are filed both in paper and electronically, ensure the location of the documents are listed on the comment section of the Essential Document Checklist.  For example if protocols are filed electronically and all versions of the consent forms are filed in paper, ensure the location of the protocol and consent forms are listed on Essential Document Checklist.

2. Monitoring and Auditing Log

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

Northwell Health ORC auditors should sign this log at every visit.

3. Delegation of Responsibilities

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

4. 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 or NIH Clinical Trials)
  • Conflict of Interest Training

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 central file, document the location of the file.

5. Credentials (CVs/Licensure) and COI forms

This section should include Curriculum Vitae (signed & dated) for all investigators and professional licensure (including DEA if applicable) for all clinical investigators and External Interest disclosure (COI) forms.

Submission of an external interest disclosure for evaluation of potential COI is required 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.

6. Screening and Enrollment of Research Participants

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.

7. Consent Form (& all subsequent versions)

This section should include consent form documents (all IRB approved and stamped versions) filed in reverse chronological order with the current approved version first.

Note: Any changes to the consent form must be submitted to and approved by the IRB prior to use. If the study has translated consent forms for Limited English Proficiency (LEP) participants, file all IRB approved and stamped translated consent form with all its versions in this section.  In addition, ensure all certificates of the translation are filed along with the translated consent forms.

8. Protocol (& all subsequent versions)

This section should include all IRB protocols and amendments (all IRB approved versions), filed 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.

9a. 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 webpage.  For external IRBs please contact their office to obtain an updated IRB roster.

9b. IRB Approvals (Initial, Renewal, and all Modifications)

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.

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.

9c. IRB Correspondence

This section should contain correspondence with the IRB over the lifetime of the study including emails communicated with the IRB, IRB information, and any other correspondence.

10. Study Completion/Closure

If your research study is complete, being closed, or if the PI is leaving and the study will no longer be continued at Northwell Health, a Final Report needs to be completed and submitted to the IRB. This section should include a copy of the Final Report filed (e.g., via IRBManager) and the IRB letter acknowledging study closure.

11. FDA Forms (for FDA regulated studies)

This section should contain FDA forms for Investigator Initiated Study involving an investigational product or requested by the study sponsor. All FDA Forms are available on the www.fda.gov web site.

12. FDA Submissions and Correspondence (for FDA regulated studies)

This section should contain correspondence with the FDA over the lifetime of the study including letters from the FDA, emails communicated with the FDA, and any other correspondence.

13. Reportable Events

This section should include a record of all reportable events that occur during the study.

13a. Protocol Deviations and Exceptions

Keep a record of all protocol deviations (minor or major) that are deviated from the currently approved protocol.

Examples of major and minor protocol deviation can be found in section, 11.0 Protocol Deviations in the HRPP Policy and Procedure Manual.

  • Major protocol deviations must be reported to the IRB within ten (10) working days of discovery using the Reportable Event Form via IRBManager.
  • Minor protocol deviations may be reported at continuing review, using a protocol deviation log.
  • Reports of protocol deviations should be submitted to the sponsor according to the requirements of the sponsor.

For further information regarding protocol deviations reporting, go to section 11.2 of the HRPP Policy and Procedure Manual.

For any changes in procedures and/or protocol activity for a single, isolated event, submit an exception through the Application for Requested Modifications (e.g., via IRBManger) to the IRB prior to its initiation.  Use the protocol exception log to keep all records of approved protocol exceptions.  Additional information regarding obtaining approval for a protocol exception can be found in section, 12.0 Protocol Exceptions in the HRPP Policy and Procedure Manual.

Note: Consider updating the protocol if the same exception may be requested multiple times.

13b. Unanticipated Problems (UPs)

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

Unanticipated problems involving risk to participants or others refer to any problem, event, or new information that meets all of the following criteria:

  • Is unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents; and
  • Related or possibly related to participation in the research, and
  • Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unanticipated problems can be AEs, SAEs, power failures, breaches of confidentiality, or the loss of study data that could have adverse effect on study participants.

Review section 13.0 Unanticipated Problems Involving Risk to Subject and Others in the HRPP Policy and Procedure Manual for further information regarding the reporting of unanticipated problems.

Contact the office of the Human Research Protection Program (HRPP) if you are unsure if an event should be deemed an unanticipated problem and reported to the HRPP.

Unanticipated problems must be submitted to the HRPP using the Reportable Event Form via IRBManager as soon as possible, but in all cases within 5 business days of any of the following but not limited to:

  • Serious Adverse Events (internal and external) that are BOTH unanticipated and related.
  • Internal and external adverse events (other than SAEs) that meet the criteria for an unanticipated problem involving risk to subjects or others.
  • Unanticipated event related to the research than exposes individuals other than the research participants to potential risk.
  • Information that indicates a change to the risks or potential benefits of the research.
  • A breach of confidentiality, including the loss of digital storage devices or research subject files with PHI; unauthorized disclosure of PHI.
  • Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant.
  • Participant complaint involving unexpected risks or cannot be resolved by the research team.
  • Protocol violation (meaning an accidental or unintentional change to the IRB approved protocol)
  • Event that requires prompt reporting to the sponsor.
  • Sponsor imposed suspension for risk.
  • New information that might affect adversely the safety of the subjects or the conduct of the clinical trial.
  • Any changes significantly affecting the conduct of the clinical trial or increasing risk to subjects.

 

  • Reportable Event Form via IRBManager
  • Unanticipated Problems Log

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), Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), 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 consider the registration if you wish to seek publication in and ICMJE journal. The FDA encourages, and the NIH requires registration of ALL clinical 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 the Clinical Trials Office at (516) 881-7067 or clinicaltrials@northwell.edu to receive log in information.

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

15. Completed (Signed) Consent Forms and Consent Process Documentation

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.

This section should include signed consent form with accompanying consent process documentation (in a form of enrollment notes or enrollment note checklist).  If re-consent is obtained, file all signed consent forms and consent process documentation during the re-consent process.

  • Consent forms for subjects who enrolled (signed consent forms) but later withdrew from the study must still be kept. Documentation should be filed explaining the withdrawal. This document can be kept with the consent form.
  • Investigators who plan on enrolling participants with Limited English Proficiency (LEP) from a particular population must provide the participants with an IRB approved translation of the approved English version consent form in participants’ preferred language.
  • If translated consent form is not available in the language of a potential participant, a short form written consent document and HIPAA Authorization form should be used. Translated short consent forms and HIPAA Authorization forms are available online in a variety of languages.

Sample Enrollment Notes: Northwell Health policy (GR089 Informed Consent and Recruitment for Human Subject Research) requires enrollment notes to be written to document the consent process for each subject.  The enrollment note should be signed and dated by the individual completing the note. It should also include a description of the circumstances relating to the subject’s ability to provide consent (e.g., capacity assessment, assent of minor, consent translation, use of a LAR, consent questionnaire completion, etc.). See sample templates that can be customized to fit your study:

16. Other

Place other important study documents in this section. This may include: Certificates of Confidentiality, literature or publications, reviewing committee correspondence and approvals, and other general correspondence.

Once the study is complete, use the Register of Archived Research Data & Records form to keep a track of all study data for a long term storage.

17. Advertising/Educational Materials (if applicable)

This section should include: Any IRB approved advertisements, recruitment flyers, written educational, or other materials provided to study participants.  Store 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.

18. Sample Tracking and Shipping (if applicable)

This section should include a log that allows tracking of research sample collection, shipment (or transport), and storage.

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.

19. 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, lab certificates, reference ranges and lab director CVs may be found on the Sharepoint site managed by the Clinical Trials Office (CTO):

To gain access to the Sharepoint site or check for updates to lab documentation posted on the Sharepoint site, please email CTO: clinicaltrials@northwell.edu

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.

20. 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. 

21. Sponsor Correspondence (if applicable)

Please document and maintain all correspondence with the sponsor (and Contract Research Organization if applicable) in this section.

22. Safety Reports (if applicable)

This section should include all external safety reports received from the sponsor and any safety monitoring reports or documentation showing compliance with any data safety monitoring plan, board or committee

23. 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:

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

Management of Investigational Drugs – Tools for managing investigational product.

Subject File Templates:

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.