1.

All NS-LIJ Health System 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 or government agencies.

Auditors should sign this log during every visit.

2.

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

3.

Study Personnel Education

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

• CITI Course in the Protection of Human Research Subjects.
• Researcher Registration Form

Click on Researcher Registration and Education 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.

Form 1a can be inserted into this section; however, this form must be updated if new personnel are added. 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
• IRB Conflict of Interest disclosure form for all “covered” investigators
• 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 Health System employees 
• FDA Part 11 Subpart B Compliance Memo regarding electronic records in the Health System
• 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.

Public Registration of Research Studies (If applicable)

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 Health System policy.

• A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes. This includes Phase I trials.
• Health related interventions include any interventions used to modify a biomedical or health related outcome (e.g. drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).
• Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

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 the IRB at 516-562-3101 or irb@nshs.edu to receive log in information.

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

This section should include a log of subjects who were screened, screen failures, enrolled, withdrawn, and completed the study.

Subject Identification Log

7.

Consent Forms

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

• Place most currently approved consent form in a plastic sleeve
• Master List of Consent and Revisions
• Tips for Consenting 

Note: Any changes to the consent form must be submitted to and approved by the IRB prior to use. Use the IRB Modifications requested form for changes.

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 anon-English proficient population. Short forms are available online in a variety of languages.

8.

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.

9.

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. Use the IRB Modifications Requested form for changes.

10.

This section should contain the most current IRB assurance letter.

11.

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 correspondence with the IRB (including emails)

Contact the IRB for a copy of any missing documents.

12.

IRB Correspondence

This section should contain correspondence with the IRB (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

13.

14.

Protocol Violations/Unanticipated Problems/Protocol Exceptions

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:

For minor and major protocol violation reported to the IRB

• IRB Form 8c
• Protocol Violation Log 

For unanticipated problems reported to the IRB

• IRB Form 7c
• Unanticipated Problem Log

For protocol exceptions approved by the IRB

• IRB form 8b
• Protocol Exception Log

Note: Some sponsor approved exceptions may need to be approved by the IRB prior to implementation.

 15.

This section should include correspondence and copies of form 7a for internal SAEs reported to the IRB, stored in reverse chronological order with the most current documents first.

• Internal SAE Log
• Internal SAE Map 
• AE/SAE Log: You can use this log for each subject enrolled in studies that involve drug intervention.

 16.

External Serious Adverse Events (if applicable)

This section should include correspondence and copies of form 7b for external SAE reported to the IRB, stored in reverse chronological order with the most current documents first.

• External SAE Log
• External SAE Map

 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, 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 NSLIJ Health System Marketing Department to ensure logo/branding is appropriate.

18.

 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 NSLIJHS policies on hazardous materials.

19.

Local Lab Certificates/Reference Ranges (if applicable)

For every laboratory utilized in your study that will be performing specimen testing in which results are validated (not experimental), place a copy of the most updated:

• Lab certificate(s) and reference ranges
• Lab director’s CV

• Core & Hospital Lab: (516) 719-1100

Click on the links below for the lab certificates, lab director’s  CV and reference ranges for studies that use NSLIJ Health System Laboratories

Monter Cancer Center:

• 2012 CLIA Permit for Monter Lab 
• 2012 CAP Permit for Monter Lab 
• 2012 COQ for Monter Lab 
• 2012 Lab Director License for Monter Lab 
• Monter Lab Director CV 

North Shore University Hospital:

• 2012 CLIA Permit for NSUH Lab 
• 2012 CAP Permit for NSUH Lab 
• 2011 Lab Director License for NSUH Lab 
• NSUH Lab Director CV 

Long Island Jewish Hospital:

• 2012 CLIA Permit for LIJ Lab 
• 2012 CAP Permit for LIJ Lab 
• 2012 COQ for LIJ Lab 

Core Laboratory:

• 2012 CLIA Permit for Core Lab 
• 2012 CAP Permit for Core Lab 
• Core Lab Director CV 2010 
• Core Lab Director License 2012 
• Core Lab Reference Ranges 

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 Dept. 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.

21.

Sponsor Correspondence (if applicable)

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

22.

 Other

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

23.

Helpful 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.

A.

Sample Enrollment Notes: Enrollment notes should be written to document the consent process for each subject, signed and dated by the person obtaining consent.

• Sample Enrollment Notes
• Enrollment Note Template

B.

Audit Tools: All NS-LIJ Health System IRB approved 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:

• Informed Consent Self-Audit Checklist
• GCP Quality Improvement though Self-Assessment checklist

C.

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

Templates:

• Note to File
• Progress Notes - Use these note sheets to document the progress of study participants or to clarify any information related to your study.
• Register of Archived Research Data & Records

Logs:

• Telephone Log
• Investigational Drug/Biologic Accountability Record
• Investigational Device Accountability Log
• Temperature Log

We’d like to hear from you. If you have suggestions, comments, or questions about this regulatory binder, please contact:

Cerdi Beltre at cbeltre@nshs.edu or Emmelyn Kim at ekim@nshs.edu