1. Stanley Estime, MSCI December 9, 2014 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

2. 2 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)

3. 3 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)

4. 4 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

5. 5 Essential Documents (All Studies) SectionPurposeConsiderations/ Recommendations ProtocolDemonstrates 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

6. 6 Essential Documents (All Studies) SectionPurposeConsiderations/ Recommendations LogsAssists 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.

7. 7 Essential Documents (All Studies) SectionPurposeConsiderations Informed ConsentDocuments 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 CollectionMaintains 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.

8. 8 Essential Documents (All Studies) SectionPurposeConsiderations TrainingDocuments 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.

9. 9 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)

10. 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

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

12. 12 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).

13. REDCAP - eBinderBox.Com – eBox Binder Server basedCloud based Access to Data DictionaryUser-friendly UI CustomizableAssign task & reminders Single sign-on (Novell) iOS, WebOS, Android Highlights of Each Electronic Binder Platform 13

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

15. Questions?  Leslie Howes, OHRA Director (lhowes@hsph.harvard.edu)lhowes@hsph.harvard.edu  QA/QI Specialists  Stanley Estime (sestime@hsph.harvard.edu)sestime@hsph.harvard.edu  Lisa Gabel (lgabel@hsph.harvard.edu)lgabel@hsph.harvard.edu  Alyssa Speier (aspeier@hsph.harvard.edu)aspeier@hsph.harvard.edu  OHRA: www.hsph.harvard.edu/ohrawww.hsph.harvard.edu/ohra  See OHRA web site for department-assigned IRB Review Specialist and contact information 15