Stanley Estime, MSCI

December 9, 2014

Record Keeping: What is Regulatory Documentation and how should it be maintained?

Tel: 617-432-2164E-mail: qip@hsph.harvard.edu

URL: www.hsph.harvard.edu/ohra/qip

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Today’s Agenda

QIP Regulatory Binder– Review of Contents/Sections

Tips for Successful Record Keeping QIPs New Electronic Record Keeping Applications:

eRegulatory Binder (REDCap & eBox (Box.Com)

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QIP Regulatory Binder

Based on GCP list of Essential Documents and OHRA’s Recordkeeping/Record Retention requirements

Provides a template for maintaining and organizing documentation to ensure compliance with federal regulations, institutional policies and good clinical practice

– Alternatives exist: You can create your own way of organizing these documents that works best for you and your study team just BE CONSISTENT

QIP provides record keeping recommendations and a regulatory binder based on best practices

A study specific Binder will be provided based on the type of research being conducted (e.g., Social Behavioral, Biomedical, or FDA)

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Binder Sections Overview(Essential Documents)

Study-Specific: Lab Documents FDA Investigational Brochure Drug/Device Financial Disclosure NIH Sponsor DSMB Local Review

All Studies: Protocol Staff CVs Staff Licensures Logs IRB Documents Consent Forms Data Collection Training

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Essential Documents (All Studies) Section Purpose Considerations/

Recommendations

Protocol Demonstrates investigator and/or sponsor agreement to the protocol. Highlights current study objectives and procedures.

Ensure that the version number/date reflects the current protocol.

CVs and licensures

Confirms staff qualifications to conduct a study or perform delegated tasks.

CVs and licenses should be updated every 2 years to confirm that the information is accurate and current.

Staff should sign and date CVs

Maintain licensures for staff conducting clinically study related procedures

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Essential Documents (All Studies)

Section Purpose Considerations/

Recommendations

Logs Assists with the collection of data that is required by or reported to the IRB or other regulatory authorities (e.g., Staff Delegation of Responsibility Log)

Information in logs can be customized to fit a specific study or added to existing electronic versions currently maintained on site.

IRB Documents

Demonstrates that the IRB have reviewed and approved the study prior to initiation and continuing review, protocol modifications and reportable new information is communicated to the IRB.

File correspondences for a given submission in reverse chronological order to ensure an accurate timeline from study start-up to completion.

Keep submissions, requires modifications, investigator’s response and approvals together.

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Essential Documents (All Studies)

Section Purpose Considerations

Informed Consent Documents that information is given to participants that support their ability to give informed consent.

Maintains original copies of all IRB approved consent forms.

Ensure that staff obtaining consent is using the most recently approved consent form.

Data Collection Maintains original copies of all forms used to collect study data (e.g., case report forms or questionnaires/ surveys).

Only blank copies of forms should be kept in regulatory file. Participant files should be maintained separately in participant binder.

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Essential Documents (All Studies)

Section Purpose Considerations

Training Documents adequate training for all IRB approved personnel (e.g., CITI, protocol specific or sponsor training).

Maintains documentation of all training records and certifications.

Any HSPH affiliate working directly with human subjects’ data or tissue or has access to identifiable information must fulfill CITI training requirements every 3 years.

Sponsor training requirements and timeframes may vary.

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Study-Specific Documents

Tissue/blood Specimens Laboratory Documents

(e.g. - Director’s CV, Lab Normals and Certifications)

Drug/Device FDA 1572 (drug) or

Investigator Agreement (device)

Investigational Brochure (drug) or Device Manual (device)

Drug/Device Accountability IND/IDE Application

Sponsored Financial Disclosures/Agreements NIH grant application & progress

report

Data Monitoring DSMB Charter and Reports

External Review Local Ethical Approval Notice

(external IRB, ERB or CAB)

OHRA Record Retention Policy

Maintain documentation at least 7 years from study closure date

Check with sponsor to ensure compliance with their record retention policies

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Tips for Successful Record Keeping

Address and resolve documentation problems immediately

Review documentation routinely Document and update materials in real time

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Tips, continued…Electronic Recordkeeping

Maintain signed and dated note-to-file indicating the location of electronic correspondences.

Ensure that electronic copies are available to study staff and regulatory authorities.

Maintain copies of documents and correspondences with the original signatures (pdf).

REDCAP - eBinder Box.Com – eBox Binder

Server based Cloud based

Access to Data Dictionary User-friendly UI

Customizable Assign task & reminders

Single sign-on (Novell) iOS, WebOS, Android

Highlights of Each Electronic Binder Platform

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Demonstration of Key functions of eBinder(s)

Storing

Sharing

Searching

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Questions?

Leslie Howes, OHRA Director (lhowes@hsph.harvard.edu)

QA/QI Specialists

Stanley Estime (sestime@hsph.harvard.edu) Lisa Gabel (lgabel@hsph.harvard.edu) Alyssa Speier (aspeier@hsph.harvard.edu)

OHRA: www.hsph.harvard.edu/ohra

See OHRA web site for department-assigned IRB Review Specialist and contact information

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