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Clinical Research Responsibilities for NIDCR-Funded Investigators PowerPoint Presentation
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Clinical Research Responsibilities for NIDCR-Funded Investigators

Clinical Research Responsibilities for NIDCR-Funded Investigators

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Clinical Research Responsibilities for NIDCR-Funded Investigators

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  1. NIDCR CROMS Clinical Research Operations and Management Support Rho, Inc., Federal Division National Institute of Dental and Craniofacial Research National Institutes of Health Clinical Research Responsibilities for NIDCR-Funded Investigators V4.0 2013-02-28

  2. Disclaimer • Note that this is a general slide presentation designed for a broad audience of clinical researchers. • Accordingly, some sections may not apply to your protocol. • Information that may not be applicable for all studies is indicated via blue italics.

  3. Disclaimer • Examples include references to: • Investigational Product (IP), the Investigator’s Brochure (IB), or a study pharmacist • Safety reporting and adverse events • Randomization and unblinding procedures • Regulatory authorities • Clinical treatment (for a behavioral or study or a registry)

  4. Basis for Research Roles and Responsibilities • Good Clinical Practice (GCP) Guidelines (ICH-E6) • Widely accepted international research standards • Title 45 Code of Federal Regulations (CFR) Part 46 • Applies to federally funded research • Federal regulations to protect human subjects • Subpart A: The Common Rule • IRB roles and responsibilities/Informed Consent

  5. NIDCR Study Types • Clinical Trials involving a biomedical or behavioral intervention • Clinical Research Studies, including: • Observational • Specimen Collection • Epidemiology or Surveillance studies

  6. Objectives To review keyroles and responsibilities of investigators and staff engaged in NIDCR-funded research • Human Subject Protection • Administrative and Regulatory Responsibilities • Research Planning and Considerations • Documentation and Record Keeping

  7. Human Subject Protection:IRBs and the Informed Consent Process

  8. The Institutional Review Board or Ethics Committee • Required for human subjects research supported by DHHS • Must register IRB with OHRP/File FWA • Applications can be submitted online • Commitment to comply with 45 CFR Part 46

  9. IRB Requirements • Membership, functions, and operations • Initial and continuing review of research • Criteria for approval of research • Decisions regarding termination/suspension of study due to harm or noncompliance • Documentation and record keeping

  10. IRB and Investigator Interactions • Know your IRB’s review schedule and process • Obtain/document IRB approval prior to initiating research • Obtain/document IRB approval prior to implementing any protocol amendments (administrative or otherwise) • Notify IRB regarding adverse events (AEs) and unanticipated problems (UPs) as required • Obtain and document IRB acknowledgement of study completion

  11. The Consent Process • Obtain without coercion or undue influence • Language understood by subjects • Cannot contain language waiving subject’s legal rights • Cannot release institution from liability for negligence • Answer questions/allow time for consideration • Subjects must receive signed/dated copy of the consent document

  12. Elements of Consent Document • Statement that the study involves research • Statement that participation is voluntary • Information about purpose, duration, and procedures • Number of subjects involved in the study • Description of risks, benefits, and alternatives • Information about compensation/care for injury • Statement regarding confidentiality of records

  13. Elements of Consent Document (continued) • Description of possible unforeseen risks • Circumstances for termination without subject consent • Consequences of withdrawing from the study • Additional costs that may result from participation • Statement that new research findings will be shared • Contact information for questions/concerns

  14. Special Provisions for Vulnerable Populations • Title 45 CFR Part 46; Subparts B, C, and D • Subpart B: Additional protections for pregnant women, human fetuses, and neonates • Subpart C: Additional protections for prisoners • Subpart D: Additional protections for children

  15. Administrative and Regulatory Responsibilities

  16. Administrative and Regulatory Responsibilities Investigators who are responsible for study conduct should: • Have appropriate education, experience, and training • Maintain current CV and credentials • Thoroughly understand and comply with the protocol • Comply with applicable regulations/GCP guidelines • Follow your institution’s HIPAA requirement policies • Permit monitoring by sponsors and their representatives

  17. Administrative and Regulatory Responsibilities (continued) • Provide and document protocol, GCP/regulatory training • Maintain a delegation of responsibilities log • Maintain training records/log • Maintain screening and enrollment logs • Maintain subject code list • Maintain monitoring visit log • Create and maintain an investigator binder to store documentation and records

  18. Research Planning and Considerations

  19. Research Study Planning When designing and developing a study protocol, consider: • Time needed for the development of: • the protocol and consent document • additional documents such as the Manual of Procedures and Case Report Forms/Data Collection Tools • Recruitment and enrollment strategies for study population • Necessary time commitments for all investigators

  20. Research Study Planning (continued) • Adequate ancillary staff support • Proper training of research staff • Available facilities and space • Time required for review of these items by NIDCR and the IRB

  21. Protocol Adherence • Document investigators’ agreement to follow the protocol • NIDCR protocol template has sign-off page • Adhere to the IRB-approved protocol/protocol amendments • Only deviate from the protocol to avoid immediate hazards to subjects • Document and report all protocol deviations to the IRB

  22. Adverse Event (AE) Reporting • Review protocol for reporting requirements • Notify subjects of care needed and provide referral • Actively monitor, ensure care for, and document AEs • Follow to resolution • Report AEs to the IRB/Safety Committee and comply with any specific guidance

  23. Unanticipated Problem (UP) Reporting • Review protocol for reporting requirements • Train study team members on UP definition • Report UPs to the IRB/other oversight bodies specified by the protocol, and comply with any specific guidance • Actively monitor, ensure care for, and document UPs • Follow to resolution

  24. Documentation and Record Keeping

  25. Adequate Documentation, Record Keeping, and Retention • Permits evaluation of the conduct of a study • Permits evaluation of data collected • Demonstrates GCP and compliance with applicable regulatory requirements • Facilitates study management and oversight • Allows for monitoring and evaluation of practices

  26. Documentation:Types of Essential Documents • IRB-approved protocols, consents, advertisements • IRB correspondence/approval letters • CVs/credentials for investigators • Staff training logs/records • Delegation of Responsibilities log • Screening/enrollment logs • Subject ID code lists • Signed consent documents and data collection forms • Monitoring visit log/visit reports

  27. Monitoring • The Clinical Site Monitoring Plan will include: • Site Assessment • Site Initiation Meeting • Interim Monitoring Visits • Close-out Visit • Other monitoring may include: • Core lab • Data Coordinating Center / Data Management Center

  28. Data Collection and Management • Describe how data will be collected and maintained • Development of a Data Management Plan • Development of a source document management process • Develop Case Report Forms (CRFs) or appropriate data collection tools • Maintain source documentation • Record data on study forms in a timely manner • Examples include interview forms, questionnaires, data collection forms, research chart (paper or electronic format)

  29. Data Collection and Management(continued) • Ensure data is accurate, complete and legible • Data corrections should not obscure original entries • Implement data quality control procedures

  30. Specimens • Includes (but is not limited to) collection, labeling, processing, storage, shipment, and tracking of specimens • Handling in accordance with the requirements of the protocol, MOP, IRB, and applicable regulations • Tracking of final disposition of samples at end of study

  31. In Summary • 45 CFR 46 & ICH E6 GCP Provides Guidance and Standards for: • Rights, safety, and well-being of subjects • Roles and Responsibilities of Investigators and Research Staff • Study conduct and protocol management • Safety reporting • Documentation and Record Keeping

  32. Questions?

  33. Resources

  34. NIDCR Resources Forms • NIDCR Investigator of Record Agreement • Delegation of Responsibilities Log • Training Log • Site Screening and Enrollment Log • Subject Code List • Adverse Event Forms • Monitoring Visit Log

  35. NIDCR Resources (Continued) Training Presentations • Investigator Responsibilities (ICH & GCP) These resources and other tools are available through NIDCR’s Toolkit for Clinical Researchers: