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

Stanley Estime, MSCI October 19, 2015 Record Keeping: What is Regulatory Documentation and how should it be maintained? Tel: 617-432-2164 E-mail: qip@hsph.harvard.edu URL: www.hsph.harvard.edu/ohra/qip

Today’s Agenda QIP Regulatory Binder Review of Contents/Sections Tips for Successful Record Keeping QIPs Electronic Record Keeping Applications: eRegulatory Binder (REDCap) & eBox (Box.Com)

QIP Regulatory Binder Based on GCP list of Essential Documentsand 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) 3

Study-Specific: Lab Documents FDA Investigational Brochure Drug/Device Financial Disclosure NIH Sponsor DSMB Local Review Binder Sections Overview(Essential Documents) All Studies: • Protocol • Staff CVs • Staff Licensures • Logs • IRB Documents • Consent Forms • Data Collection • Training 4

Essential Documents (All Studies)

Study-Specific Documents 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) 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) • IND/IDE Application 9

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 10

Tips for Successful Record Keeping • Address and resolve documentation problems immediately • Review documentation routinely • Document and update materials in real time 11

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). 12

Highlights of Each Electronic Binder Platform 13

Demonstration of Key functions of eBinder(s) Storing Sharing Searching Communicating 14

Storing - User Interface

Uploading Documents

Sharing Data Box REDCap

Sharing Data Box

Searching Data Field level searches

Searching Data Box – File/Document level searches

Internal Communication REDCap Box

Communication - Notifications E-mail notification for completed tasks Pending and overdue task notifications

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 23

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