1 / 40

Managing Clinical Study Processes & Procedures to Facilitate a Successful BIMO Inspection

Managing Clinical Study Processes & Procedures to Facilitate a Successful BIMO Inspection. Ginger Clasby, MS Promedica International 714-799-1617 x 25 gclasby@promedica-intl.com. What is BIMO?.

Download Presentation

Managing Clinical Study Processes & Procedures to Facilitate a Successful BIMO Inspection

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Managing Clinical Study Processes & Procedures to Facilitate a Successful BIMO Inspection Ginger Clasby, MS Promedica International 714-799-1617 x 25 gclasby@promedica-intl.com

  2. What is BIMO? • BIoresearch Monitoring Organization established to assure quality & integrity of new product approval data • Reports into Office of Compliance • Program involves comprehensive on-site inspections & data audits

  3. General Procedures for BIMO Compliance Program Implementation • ORA Program Guidance Manual References • IRBs – 7348.809 • Sponsors, CROs & Monitors – 7348.810 • Clinical Investigators – 7348.811

  4. Entities Involved in FDA-Regulated Research: Study Sponsor • Initiates, but does not actually conduct, the study of a medical product

  5. Entities Involved in FDA-Regulated Research: Study Monitor • Designated by sponsor to oversee study progress

  6. Entities Involved in FDA-Regulated Research: Study Investigator • Provides immediate direction regarding test product administration to study subjects • If study conducted by a team of individuals, investigator is responsible leader of team

  7. Entities Involved in FDA-Regulated Research: IRB • Formally designated committee reviewing biomedical research involving human subjects • Must be established, operated & function in conformance with 21 CFR Part 56 (Institutional Review Boards)

  8. Entities Involved in FDA-Regulated Research: Study Subject • Receives test or control product in accordance with study protocol

  9. Obligations of Study Sponsors21 CFR 312, 21 CFR 812 • Obtain FDA approval prior to study initiation • Manufacture & label product appropriately • Initiate, withhold, or discontinue clinical trials as required • Refrain from commercialization of product

  10. Obligations of Study Sponsors 21 CFR 312, 21 CFR 812 • Control distribution & return of product • Select qualified investigators to conduct studies • Disseminate appropriate information to investigators • Select qualified persons to monitor study conduct

  11. Obligations of Study Sponsors 21 CFR 312, 21 CFR 812 • Monitor clinical investigations adequately • Evaluate & report adverse events • Maintain adequate study records • Submit study progress reports & final results

  12. BIMO Inspection Focus • Study organization & personnel • Investigator selection & monitoring • Monitoring procedures & activities • Data collection & handling • Investigational product accountability

  13. Clinical Study Organization & Personnel: Contractors • If CRO, central lab, reading center, etc. provides study-related activities, execute written contract • Maintain written summary of key study activities & associated responsibilities

  14. Clinical Study Organization & Personnel: Clinical Research Dept • Maintain organization chart, including designated product team • Reflect team membership changes & dates of effectivity • Support with regularly updated resumes & summaries of relevant training

  15. Clinical Study Organization & Personnel: Study Investigators • Maintain list of study investigators with whom investigator agreements were executed • Supplement with study enrollment numbers by investigator • List should reflect dates of study participation initiation & completion

  16. Clinical Study Organization & Personnel: Protocol & Related Documents • Maintain master copy of original protocol & amendments • Maintain master copy of ICD template • Maintain master copy of original CIB or report of prior investigations & amendments

  17. Clinical Investigator Selection & Monitoring Assessment • Sponsor should maintain filing system containing relevant documentation for each study investigator

  18. Clinical Investigator Selection & Monitoring: Investigator Files • Protocol Section • Fully executed signature page for original protocol & each amendment • CIB/Rpt of Prior Investigations Section • Fully-executed signature page for original report & each amendment

  19. Clinical Investigator Selection & Monitoring: Investigator Files • Investigator Agreement Section • Fully-executed NDA & investigator agreement(s) & each amendment • Investigator financial disclosure questionnaire, curriculum vitae & medical license

  20. Clinical Investigator Selection & Monitoring: Investigator Files • IRB Approval Section • Documentation of approval of investigator(s), protocol(s) & consent document(s) • May also include approvals of subject recruitment or information materials; declarations of translation

  21. Clinical Investigator Selection & Monitoring: Investigator Files • IRB Correspondence Section • IRB membership list(s) or multiple assurance number • Periodic progress reports • Notification of AEs • Miscellaneous correspondence

  22. Clinical Investigator Selection & Monitoring: Investigator Files • Monitoring Section • Monitoring log indicating dates of each visit & monitor who performed • Site visit reports

  23. Clinical Investigator Selection & Monitoring: Investigator Files • Product Accountability Section • Documentation of product shipment, receipt, use or return

  24. Clinical Investigator Selection & Monitoring: Investigator Files • Study Management Logs Section • Signature authorization logs • Screening/enrollment logs • Calibration/service logs

  25. Clinical Investigator Selection & Monitoring: Investigator Files • Memos to File Section • Sponsor-Investigator Correspondence Section • Adverse Event Correspondence Section • Internal Correspondence Section

  26. Monitoring Procedures & Activities Assessment • Be prepared for detailed review of: • Inspector-designated monitoring reports & subject records • All unanticipated, product-related & serious AE reports

  27. Monitoring Procedures & Activities: Monitoring Plan & Procedures • Plan should include: • Monitor responsibilities & training plans • Monitoring procedures & checklists/logs • Guidelines for reporting AEs • Guidelines for reporting protocol deviations • Should be subject to change controls

  28. Monitoring Procedures & Activities: Subject Data Line Listings • Facilitate efficient comparison of computerized data vs. CRFs by: • Generating listings physically resembling CRFs • Segregate listings by subject

  29. Monitoring Procedures & Activities: Data Queries • Query documentation should be chronologically ordered & readily available for review with CRFs • Query log should be maintained to track queries generated & their resolution

  30. Monitoring Procedures & Activities: Adverse Events • Maintain a log of unanticipated, product-related & serious adverse events • Log may contain: • Date of initial event report • Dates of initial IRB & FDA notification • Documentation of follow-up reporting • Date of notification of other investigators (if applicable)

  31. Monitoring Procedures & Activities: Protocol Deviations • Maintain a log of protocol deviations to enable quick assessment of non-compliance by deviation type & investigator

  32. Data Collection & Handling Assessment • BIMO inspector evaluates integrity of data collection, management & analysis activities in support of submission

  33. Data Collection & Handling: Clinical Study Summary • Maintain a list of clinical studies included in marketing application • Be prepared to address rationale for studies not submitted

  34. Data Collection & Handling: Data Management Plan & Procedures • Plan should include: • Annotated CRFs • Database field definitions • Automated edit checks • Database validation plan • Data collection, maintenance & analysis procedures • Should be subject to change controls

  35. Data Collection & Handling: Statistical Analysis Plan & Procedures • Plan should include: • How study population(s) analyzed • General analysis conventions • Subject disposition definitions • Variables to be analyzed & analysis methodology • Sample tables & supporting listings

  36. Data Collection & Handling: Data Tables Confirmation • Maintain well-labeled data listings supporting each study data table • Listings should contain confirmation of verification vs. associated table

  37. Investigational Product Accountability Assessment • Records should be logically organized (e.g., by sterilization lot) so inspector can readily review

  38. Investigational Product Accountability: Manufacturing, Labeling, Release, Storage • Typically maintained within sponsor manufacturing procedures • Procedures should include checklists/logs to confirm conformity with procedural requirements

  39. Investigational Product Accountability: Product Distribution • Maintain detailed log of product shipment, use, return or disposal

  40. Conclusion • These suggestions should provide stimulus for planning & maintaining clinical program operations to facilitate: • Efficient project performance • An uneventful BIMO inspection

More Related