Developing an Internal Monitoring Plan for Investigators

1. Stanley Estime, MSCI, CIP QA/QI Specialist Developing an Internal Monitoring Plan for Investigators QA/QI Boot Camp August 23, 2013

2. Internal Monitoring Process

3. Create a Culture of Compliance • Proactive vs. Retroactive • Checks and Balances • Implement Quality Control across projects

4. Develop an ‘auditing system’ that goes beyond the checklists • Tools: • Self Assessment Checklist • Quality Assurance Checklist • SOPs • Monitor queries to clean up missing data points *One time fixes … but issues remain

5. Does external monitors/ consultants solve the “problem” How can we avoid the Band Aid approach to resolving non-compliance?: • How effective are the audit reports • Do corrective actions always apply • Do we need more f/u visits • More focus on entrance/exit interviews

6. What role are internal Quality Improvement Programs playing Investigators struggle to determine if QIP is “friend or foe” • Is role on site as an enforcer for the IRB or other regulatory bodies to ensure institutional polices and federal regulations are adhered to. • Mediator between IRB and Investigator • Friendly set of eyes with both the investigator’s and institution’s interest in mind

7. Keys to developing a successful internal monitoring plan • Make sure all the key players are involved • Include those who are actually doing the work • Individual-level Self Assessments • Cross-reference internal audits across protocols and individuals with varying levels of experience • Don’t check your own work • Go beyond searching for data discrepancies or missing fields • Monitor the monitoring plan • Period checks triggers early warning systems

8. What are main advantages of conducting monitoring activities remotely? • Reduce cost of travel • Real-time access to study documents (enrollment log, regulatory documentation, participant data) • Real-time communication (data queries and data cleaning) • Detect and address problems/errors early • Less disruptive to the site’s daily activities • Convenience for monitors/reviewers

9. Remote reviews promotes compliance • Enhances ability to identify actual and/or potential protocol deviations, record keeping and data collection instruments/tools completion deficiencies • Ensures proper timely reporting to IRB/EC, FDA, sponsor, and other regulatory bodies • Allows more time for review of documents and more accurate data verification

10. Compliance can still be achieved through low-tech / low cost measures • Remote File Sharing Applications: • Dropbox, Box.com, SharePoint, Pando, Wikisend, Send this file, Remote web access desktop sharing (MS Windows Server) • Electronic CRFs/Notebooks/Study Mgt. Tools • REDCap, FileMaker Pro, MS Access/Excel with field validations • Side by Side Comparison • MS Word, Diff Doc • Online Conferencing/Video Chat • Skype, Facetime, WebEx, Go To Meeting, Google Chat

11. Key Areas to Review • Regulatory Documentation • Informed Consent Documentation • Case Report Forms/Data Collection Tools • Data checks for eligibility, consistency, completeness, and range (dates, adherence to protocol timelines);Reporting • Data trends, anomalies, or frequencies of errors • Source/data verification • Study Mgt Tools: Logs and Checklists • Personnel Files (CVs, licensures, training)

12. Additional Areas to Monitor when Applicable • Drug/Device Accountability • Shipment, storage, dispensing, disposition • Lab Certifications / Normal Ranges • Focus Reviews • For Cause Audits • Suspected non-compliance in specific area (e.g participant payment information)

13. Benefits of Electronic Records • Eliminates legibility problems due to poor penmanship • Built-in validations & range checks on e-forms (limits number of findings associated with incomplete or inaccurate information) • Allows faster, easier source data verification (side-by-side comparison) • Established audit trails • Protection against data loss (back-ups)

14. Challenges: Site Limitations • Use of technology is not always feasible: Internet connectivity and accessibility issues • Resource Limitation (staffing & infrastructure): Difficulty maintaining electronic or paper records and/or assigning staff to support such needs • Communication: Sites across multiple time zones and language barriers • Data Security Standards: Best practice standards for ensuring confidentiality/security are not consistent throughout all regions

15. Challenges: Concurrent Review • Local Ethics Committee review/approval • Delays as a result of limited resources (e.g. infrequent meetings) • Corruptions (e.g. conditional approval fees, bribes) • Multiple templates – constantly changing • Ensure consistency with submissions, amendments and approvals • Local boards acceptance of CF language • Regional and cultural differences impact on what can/cannot be included in consent form

16. Challenges: Concurrent Review • Local language and translations of dialects • Finding qualified translators • Different regulatory infrastructure or interpretation of regulations • Adverse Event Reporting • Informed consent requirements • Acceptance of Exemption and NHSR determinations

17. Challenges: Reporting • Reporting to one IRB and not the other • Real-time reporting/tracking of serious unanticipated events • Often delayed until continuing review, next monitoring visit, or conference call Tip: Encourage sites to maintain an events reporting log and review for completeness/accuracy on a weekly basis

18. Tips for determining frequency • Depends on complexity of study, and past non-compliance history of study staff and PI track record • Take a risk-based approach: Focus on critical data points that will ensure participant protection and data quality • Encourage sites timely reporting of activities by monitoring/reviewing logs (weekly or monthly)

19. Technology is great, but communication is key • Interact over the phone on key issues, be careful with email • Visual interaction is best when possible (Skype/Face-time) • Conduct web-based conference calls and training sessions (Go to Meeting/WebEx) • Provide a written report of findings after each monitoring activity: corrective actions and follow-up on resolution

20. Questions?