Regulatory BinderVersion 2018

Instructions:

The Regulatory Binder can be a paper document set or an electronic “binder.” Either method of organization is acceptable as long as it is easily accessible when items need to be added, displayed or produced for auditor/monitor visits. If your study is funded, keeping a binder in an electronic format should be approved by the sponsor or monitoring/auditing group and this official approval should be filed with your regulatory documents.

Some of these documents are in RAMS System. In the case of RAMS submissions, RAMS will be storing them. For documentation purposes, put a memo-to-file under the related binder tab that notes the (RAMS submission) “tab” that houses the applicable document.

If documents are maintained electronically, write an SOP indicating the location and who (name of professional position) maintains them. Include the SOP in the related portion of this binder.

Special Thanks:

Portions of this Regulatory Binder were adapted from the Boston Children’s EQuIP program with approval.

Regulatory Binder Contents

Tabs

Tab 1 | Protocol and/or RAMS submission

Required Content1. Original protocol and all amended versions 2. Original protocol summary and all amended versions (if applicable)3. All versions of the protocol should contain a version number and date

Tab 2 | CVs for All Study Staff

Required Content1. CVs for all Study Staff2. CVs should be signed, dated, and updated every 2 years to verify that the

information is accurate and current.

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If CVs are filed collectively for the department, include a signed and dated note-to-file indicating the location

Tab 3 | Licensure

Required Content1. Valid, current licenses/certification for all professional study staff (e.g.,

medical, nursing license and laboratory managers)

Tab 4 | Training for All Study Staff*

*Anyone working directly with human subjects, data, or tissue that can be linked back to individual subjects, must fulfill human subjects training requirements (CITI). Biomedical or Social Behavioral certificates must be renewed every two years. Good Clinical Practice (GCP) must be renewed every three years. After 3 refresher courses, individuals are required to take the Basic Course again. See https://research.vcu.edu/human_research/citi_requirements.htm

All Principle Investigators (PIs), Co-Investigators, and those meeting the NIH definition of "Key Personnel" must complete training regardless of whether or not they have access to identifiable data/tissue or contact with subjects. 

Anyone (regardless of role) working on a protocol identified as "Not Human Subjects Research" are not required to complete these training.

Required Content1. Copy of CITI human subjects training certifications for all study staff. This

includes Basic, refreshers and GCP.2. Record these certificates on the training log found at

https://research.vcu.edu/human_research/guidance.htm#toolkit3. Training log that notes staff training on specific study conduct.The should be

placed at the beginning of this tab.

Tab 5 | Logs

Logs should be updated in a timely manner (usually one week) whenever there are changes and/or additions. Staff updates must be submitted to the IRB in RAMS as a roster change amendment.

Required Content1. 1. Refer to the Checklist for logs/documents required for Clinical Trials or

studies run by GCP requirements. Other recordkeeping tools are available at this location: https://research.vcu.edu/human_research/guidance.htm#toolkit

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2. Screening logs3. Authority delegation logs4. Copy of Adverse Event and Unanticipated Problem logs

Tab 6 | IRB

Most IRB documents will now be maintained in RAMS. However, it is best practice to review the RAMS documents periodically to ensure all these items are present. If something is missing, please notify the IRB office.

All RAMS submission documents, including approved/validated recruitment materials and additional study information distributed to participants should include version numbers and/or dates.

Required Content

1. Copies of signed and dated submissions:a. Initial RAMS submissionb. Continuing Reviewsc. Amendmentsd. Unanticipated Problem Reportse. Sponsor and monitor reports/communicationsf. DSMB Reportsg. Unanticipated Problem reportsh. SAE reports & logi. WIRB, CIRB, etc., documentsj. Closure documents including final reports.

2. Original Approval letters and or notification of IRB decisions3. Copy of Investigator responses to IRB communications4. Approved recruitment materials5. Approved study related information distributed to participants or LARs.6. All foreign language related materials (if applicable) See

https://research.vcu.edu/human_research/irb_wpp/XI-5.htm7. A print out VCU FWA information from

https://research.vcu.edu/human_research/irb_wpp/II-3.htm8. Any additional correspondence related to the study

Tab 7 | Consent Forms

Consent format was updated by Federal Requirement in 2018. Please refer to the VCU IRB consent templates. See https://research.vcu.edu/forms/index.htm#irb_forms

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Required Content1. Original copies of all IRB approved versions (evident by the IRB approval/validation

stamp) with version dates or numbers2. Copies of foreign language consent materials3. Consent Process Logs available [add link?]

Tab 8 | Investigator’s Brochure (if applicable)

Required Content

1. The most recent version of the investigator brochure or product information2. Previous versions of the investigator brochure or product information3. Upload updated versions to RAMS as they are available4. If the investigational product is marketed and its pharmacology is widely understood,

a basic product information brochure or package insert may be an appropriate alternative.

Tab 9 | Laboratory Documents (if applicable)

Required Content

1. Lab Certification (e.g. CLIA, CAP) and updates2. Normal lab/reference values and updates3. Keep updated documents to exhibit the competency of all lab facilities being utilized,

and to support the reliability of test results.4. If lab documentation is filed separately, write a signed and dated note-to-file

indicating the location and file here.

Tab 10 | Drug and Device Documentation

Required Content

1. Drug/device shipment and receipt records2. Drug/device dispensing log3. Drug/device accountability/storage logs4. Safety reports 5. If applicable, write a signed and dated note to file indicating where documentation is

kept (e.g. Research Pharmacy). Include the note to file here.

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Tab 11 | Study Documents (Measures, CRF, etc.)

Required Content

1. Include a blank set of Case Report Forms (CRFs), data collection sheets, study questionnaires, etc. Be sure that version numbers and dates are included on all documents.

2. Certificate of Confidentiality and “Note to File” should be stored under this tab.

Tab 12 | FDA

This section is for Investigator regulatory files. Studies associated with VCU Faculty-Held IND or IDEs have very specific sponsor obligations and regulatory needs. Additional documents and templates may be found at the VCU Faculty-Held IND or IDE program’s website at go.vcu.edu/indide or consult the office directly at indide@vcuhealth.org with questions.

Required Content

1. Adverse Event Reports 2. Copy of all version of the Form FDA 1572 (original is sent to sponsor)3. Update the 1572 each time there is a change to any of the information originally

provided. Notify the Sponsor of updates.4. Copy of any FDA Warning letters that are applicable to this study

Tab 13 | NIH

Required Content

1. Copy of the NIH Grant application and progress report2. Progress reports3. Any additional study correspondence (e.g. e-mails) with the NIH and Collaborators.

Tab 14 | Sponsor

This section is for Investigator regulatory files. Studies associated with VCU Faculty-Held IND or IDEs have very specific sponsor obligations and regulatory needs. Additional documents and templates may be found at the VCU Faculty-Held IND or IDE program’s website at go.vcu.edu/indide or consult the office directly at indide@vcuhealth.org with questions.

Required Content

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1. All correspondence to and from the sponsor (e.g. letters, meeting notes, and notes of telephone calls)

Tab 15 | DSMB

Ensure that the DSMB is meeting as stated in the RAMS submission and/or protocol. If reports are not being forwarded to the study in a timely manner, reach out to the DSMB. DSMB reports should be submitted to the IRB at continuing review, unless there is a problem noted in the report. If there is a problem, the DSMB report should be submitted immediately with an unanticipated problem report.

Required Content

1. Copy of all DSMB Reports.2. Any additional correspondence (e.g. e-mails, letters, meeting minutes) with the

DSMB and its members

Tab 16 | Local Ethical Review

It is not sufficient for a U.S.-based institution to approve non-exempt human research conducted abroad. Local ethical review is required.

Required Content

1. Copy of local ethical approval notices (e.g. IRB).

2. For HHS-funded protocols:a. The review should be done by the IRB of the collaborating institution or that of

another institution in the same geographical area.b. The local IRB must be registered with OHRP and have an FWA (check online at

http://ohrp.cit.nih.gov/search/asearch.asp#ASUR).3. For non-HHS-funded protocols:

a. Review should be done by a Local Ethical Review Board or Community Advisory Board

Tab 17 | DOD Funded Studies

Items under this tab are in addition to the items under the other tabs. This tab relates to Department of Defense funded studies.

Required Content

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1. Document showing review for scientific merit. This may be the chair sign off statement.2. DOD approval document3. If study is greater than minimal risk, an independent research monitor must be appointed

and named. Place document with that information under this tab.4. If research is greater than minimal risk and recruitment occurs in a group setting, the IRB

mush appoint an Ombudsman (note the appointment date and the name of the Ombudsman).

5. IRB must approve a written summary of monitor’s duties, authorities, & responsibilities. Place this written approval under this tab.

6. Monitor has agreed in writing to perform these duties, accept these responsibilities and authorities.

7. If research is greater than minimal risk, an independent medical monitor must be appointed by name. DODD 3216.2 Section 4.4.3-4.4.3.2

8. If research is being conducted outside the US, US territories/possessions or subjects are not US citizens or not DOD personnel

a. Document proving host country’s permission.b. Document proving host country’s ethics board or local IRB representation has

taken place.9. If a waiver of consent is requested

a. Written permission for waiver from the Secretary of Defense is placed in this tab.b. If Navy & EFIC study, an approval document from the Secretary of the Navy

should be placed in this tab.10. If using surveys of DOD military members, their families and DOD civilian personnel

a. Approval document of DOD authority should be placed in this tab.b. If Navy, a privacy Act Statement must be displayed prominently on all Navy

personnel surveys. Store a bland copy of this survey under this tab.11. If multi-site study

a. A formal agreement regarding specificity of roles and responsibility, including a Statement of Work (SOW) with specific assignment of responsibilities should be placed under this tab.

PAMQuIP Version 3 2018 with thanks to Elizabeth Stoddert