The Protocol   making it your guide Clinical Trials Quality Assurance Compliance Office School of Medicine Presenter: Shed...
Unappealing Aspects of Protocols  <ul><ul><li>A large amount of paper </li></ul></ul><ul><ul><li>Incredibly long and compl...
Grant vs. Protocol <ul><li>A grant is a document that details the rationale and request for funding of research. </li></ul...
The Research in the Protocol  <ul><li>Categories </li></ul><ul><ul><li>Biomedical </li></ul></ul><ul><ul><ul><li>Study of ...
The Research in the Protocol  <ul><li>Objectives </li></ul><ul><ul><li>Collect Information  </li></ul></ul><ul><ul><li>Ini...
The Research in the Protocol  <ul><li>Ethics of including humans in the research   </li></ul><ul><ul><li>Is there true sci...
Protocol Content <ul><li>Title page   </li></ul><ul><li>Signature page </li></ul><ul><li>Content page </li></ul><ul><li>Li...
Today’s  Focus <ul><li>Make the protocol your guide </li></ul><ul><ul><li>How to read the protocol </li></ul></ul><ul><ul>...
Reading a protocol <ul><li>Grouping the sections of the protocol </li></ul><ul><ul><li>Why is the research being conducted...
Reading a protocol <ul><li>Why is this research being conducted? </li></ul><ul><ul><li>Summary </li></ul></ul><ul><ul><li>...
Reading a protocol <ul><li>Why is this research being conducted? </li></ul><ul><ul><li>Investigator brochure </li></ul></u...
Reading a protocol   <ul><li>How will the research be conducted? </li></ul><ul><ul><li>Study Design </li></ul></ul><ul><ul...
Reading a protocol   <ul><li>How will the research be conducted? </li></ul><ul><ul><li>Procedures </li></ul></ul><ul><ul><...
Reading a protocol   <ul><li>How will the research be conducted? </li></ul><ul><ul><li>Manuals </li></ul></ul><ul><ul><li>...
Reading a protocol <ul><li>What will be done with the data collected? </li></ul><ul><ul><li>Statistical Consideration </li...
Reading a protocol <ul><li>What will be done with the data collected? </li></ul><ul><ul><li>Be aware of possible changes i...
Reading a protocol   <ul><li>Handling the “housekeeping sections” last  </li></ul><ul><ul><li>Abbreviations & Definitions ...
Reading a protocol   <ul><li>“ Housekeeping” Considerations  </li></ul><ul><li>Consider the ethical, regulatory, practical...
Understanding a protocol <ul><ul><li>Title of protocol </li></ul></ul><ul><ul><li>The Body System/ Disease Process/Behavio...
Understanding a protocol <ul><li>Title of the Protocol </li></ul><ul><ul><li>“A Multi-center, Randomized, Phase III Active...
Understanding a protocol <ul><li>“Walk the path of the researcher ” </li></ul><ul><li>Knowledge of the Body system/Disease...
Understanding a protocol <ul><ul><li>Additional Reading </li></ul></ul><ul><ul><ul><li>Duke Medical Center Library Online ...
Understanding a protocol <ul><li>Defining research terms </li></ul><ul><ul><li>Get to know the context and intent </li></u...
Understanding a protocol <ul><li>Speak up and ask questions </li></ul><ul><li>The protocol is not a perfect document . </l...
Utilizing a protocol <ul><li>Research set-up </li></ul><ul><li>Reconciling </li></ul><ul><li>Explaining the research </li>...
Utilizing a protocol <ul><ul><ul><li>Example #1 </li></ul></ul></ul><ul><ul><ul><li>A coordinator is given a protocol writ...
Utilizing a protocol <ul><ul><ul><li>Example #1 </li></ul></ul></ul><ul><ul><ul><li>A coordinator is given a protocol writ...
Utilizing a protocol <ul><ul><ul><li>Example # 2 </li></ul></ul></ul><ul><ul><ul><li>Per the agreement for a pharmaceutica...
Utilizing a protocol <ul><ul><ul><li>Example # 2 </li></ul></ul></ul><ul><ul><ul><li>Per the agreement for a pharmaceutica...
Utilizing a protocol <ul><ul><ul><li>Example # 3 </li></ul></ul></ul><ul><ul><ul><li>A nephrology protocol requires the us...
Utilizing a protocol <ul><ul><ul><li>Example # 3 </li></ul></ul></ul><ul><ul><ul><li>A nephrology protocol requires the us...
Utilizing a protocol <ul><ul><ul><li>Example # 4 </li></ul></ul></ul><ul><ul><ul><li>The sponsor of a protocol sends safet...
Utilizing a protocol <ul><ul><ul><li>Example # 4 </li></ul></ul></ul><ul><ul><ul><li>The sponsor of a protocol sends safet...
Utilizing a protocol <ul><ul><ul><li>Example # 5 </li></ul></ul></ul><ul><ul><ul><li>An OB-GYN research group is intereste...
Utilizing a protocol <ul><ul><ul><li>Example # 5 </li></ul></ul></ul><ul><ul><ul><li>An OB-GYN research group is intereste...
Summarize <ul><li>A protocol can seem intimidating. </li></ul><ul><li>Approach the protocol answering the 3 main questions...
Final Thoughts <ul><li>Not a nursing order  </li></ul><ul><li>Overall understanding for an easier process  </li></ul><ul><...
Final Thoughts <ul><ul><ul><li>“ It’s the protocol, stupid!” </li></ul></ul></ul>
Contact Us:   <ul><li>Clinical Trials Quality Assurance Section </li></ul><ul><li>Compliance Office--School of Medicine </...
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10/13/10 1 The Protocol

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  • 10/13/10 1 The Protocol

    1. 1. The Protocol making it your guide Clinical Trials Quality Assurance Compliance Office School of Medicine Presenter: Sheda Moori
    2. 2. Unappealing Aspects of Protocols <ul><ul><li>A large amount of paper </li></ul></ul><ul><ul><li>Incredibly long and complex title </li></ul></ul><ul><ul><li>Technical language </li></ul></ul><ul><ul><li>Confidential and controlled document </li></ul></ul>
    3. 3. Grant vs. Protocol <ul><li>A grant is a document that details the rationale and request for funding of research. </li></ul><ul><li>A protocol is a document that details structure, procedures and organization for research. </li></ul><ul><ul><li>A protocol can be a part of a grant; made available via an agreement/contract; or created by the investigator. </li></ul></ul><ul><ul><li>Grant funding can occur with the inclusion of a developed protocol or development may occur later in the process. </li></ul></ul><ul><ul><li>IRB submission of a grant for review and approval of 1 research plan (protocol) at a time. </li></ul></ul>
    4. 4. The Research in the Protocol <ul><li>Categories </li></ul><ul><ul><li>Biomedical </li></ul></ul><ul><ul><ul><li>Study of the normal and abnormal physiology and development of humans. </li></ul></ul></ul><ul><ul><li>Behavioral </li></ul></ul><ul><ul><ul><li>Study of behavior of individuals or groups. </li></ul></ul></ul><ul><ul><li>Social </li></ul></ul><ul><ul><ul><li>Study of social and economic systems for use in planning public policy. </li></ul></ul></ul><ul><ul><ul><ul><li>Cost and benefits of alternate ways of providing health, educational or welfare services at national, state or local level </li></ul></ul></ul></ul>
    5. 5. The Research in the Protocol <ul><li>Objectives </li></ul><ul><ul><li>Collect Information </li></ul></ul><ul><ul><li>Initiate possible methods of prevention </li></ul></ul><ul><ul><li>Evaluate Instruments and techniques for diagnosis </li></ul></ul><ul><ul><li>Test Interventions (drug, device, biologic, procedure) </li></ul></ul>
    6. 6. The Research in the Protocol <ul><li>Ethics of including humans in the research </li></ul><ul><ul><li>Is there true science? </li></ul></ul><ul><ul><li>Does the research provide direct benefit? </li></ul></ul><ul><ul><li>Does it minimize the risk? </li></ul></ul><ul><ul><ul><li>physical </li></ul></ul></ul><ul><ul><ul><li>general welfare </li></ul></ul></ul><ul><ul><li>Does the research respect the “person”? </li></ul></ul>
    7. 7. Protocol Content <ul><li>Title page </li></ul><ul><li>Signature page </li></ul><ul><li>Content page </li></ul><ul><li>List of Abbreviations and Definitions </li></ul><ul><li>Summary </li></ul><ul><li>Background/Rationale </li></ul><ul><li>Research Objectives and Purpose </li></ul><ul><li>Study Design </li></ul><ul><li>Subject Population/Recruitment </li></ul><ul><li>Research Intervention </li></ul><ul><li>Randomization/Blinding </li></ul><ul><li>Summary of Data to be collected </li></ul><ul><li>Statistical Consideration </li></ul><ul><li>Subject Compliance and Withdrawal </li></ul><ul><li>Interim Analysis and Data Monitoring </li></ul><ul><li>Ethical Considerations </li></ul><ul><li>Finance and Insurance </li></ul><ul><li>Reporting and Dissemination </li></ul><ul><li>Appendix—Tables and References </li></ul>
    8. 8. Today’s Focus <ul><li>Make the protocol your guide </li></ul><ul><ul><li>How to read the protocol </li></ul></ul><ul><ul><li>Understanding the protocol </li></ul></ul><ul><ul><li>How to utilize the protocol </li></ul></ul>
    9. 9. Reading a protocol <ul><li>Grouping the sections of the protocol </li></ul><ul><ul><li>Why is the research being conducted? </li></ul></ul><ul><ul><li>How will the research be conducted? </li></ul></ul><ul><ul><li>What will be done with the data collected? </li></ul></ul><ul><ul><li>Handle the “housekeeping sections” of the protocol last. </li></ul></ul>
    10. 10. Reading a protocol <ul><li>Why is this research being conducted? </li></ul><ul><ul><li>Summary </li></ul></ul><ul><ul><li>Background/Rationale </li></ul></ul><ul><ul><li>Research Objectives </li></ul></ul><ul><li>The history of the research </li></ul>
    11. 11. Reading a protocol <ul><li>Why is this research being conducted? </li></ul><ul><ul><li>Investigator brochure </li></ul></ul><ul><ul><li>Package inserts </li></ul></ul><ul><ul><li>Articles </li></ul></ul><ul><ul><ul><li>Part of the protocol (usually provided by a sponsor of a protocol) </li></ul></ul></ul>
    12. 12. Reading a protocol <ul><li>How will the research be conducted? </li></ul><ul><ul><li>Study Design </li></ul></ul><ul><ul><li>Subject Population/Recruitment </li></ul></ul><ul><ul><li>Subject Compliance/Withdrawal </li></ul></ul><ul><ul><li>Research Intervention </li></ul></ul><ul><ul><li>Randomization </li></ul></ul><ul><ul><li>Methods to Avoid Bias </li></ul></ul><ul><ul><li>Summary of Data to be Collected </li></ul></ul><ul><li>Your Instructions </li></ul>
    13. 13. Reading a protocol <ul><li>How will the research be conducted? </li></ul><ul><ul><li>Procedures </li></ul></ul><ul><ul><ul><li>Observational </li></ul></ul></ul><ul><ul><ul><li>Efficacy (only “response” in Phase I studies) </li></ul></ul></ul><ul><ul><ul><li>Safety </li></ul></ul></ul><ul><ul><ul><li>Maintain Integrity and Avoid Bias </li></ul></ul></ul><ul><ul><ul><ul><li>keep the research honest </li></ul></ul></ul></ul><ul><ul><li>Note: Repository/Database procedures for future research are not relevant to a current protocol’s research objective and require a separate consenting process. </li></ul></ul>
    14. 14. Reading a protocol <ul><li>How will the research be conducted? </li></ul><ul><ul><li>Manuals </li></ul></ul><ul><ul><li>Memos </li></ul></ul><ul><ul><li>Case report forms (blank) </li></ul></ul>
    15. 15. Reading a protocol <ul><li>What will be done with the data collected? </li></ul><ul><ul><li>Statistical Consideration </li></ul></ul><ul><ul><li>Interim Analysis </li></ul></ul><ul><ul><li>Data Monitoring </li></ul></ul><ul><ul><li>Collect Data Accurately </li></ul></ul>
    16. 16. Reading a protocol <ul><li>What will be done with the data collected? </li></ul><ul><ul><li>Be aware of possible changes in the research. </li></ul></ul><ul><ul><ul><li>Interim analysis/DSMB </li></ul></ul></ul><ul><ul><ul><li>Review and approval of changes in protocol </li></ul></ul></ul><ul><ul><ul><li>Alert subjects to relevant changes (via consent) </li></ul></ul></ul>
    17. 17. Reading a protocol <ul><li>Handling the “housekeeping sections” last </li></ul><ul><ul><li>Abbreviations & Definitions </li></ul></ul><ul><ul><li>Ethical Considerations </li></ul></ul><ul><ul><li>Financing and Insurance </li></ul></ul><ul><ul><li>Reporting and Dissemination </li></ul></ul><ul><ul><li>Appendix—Tables and References </li></ul></ul><ul><li>Save for Last! </li></ul>
    18. 18. Reading a protocol <ul><li>“ Housekeeping” Considerations </li></ul><ul><li>Consider the ethical, regulatory, practical and medical center policies as you read. </li></ul><ul><ul><li>Make sure results can be duplicated. </li></ul></ul><ul><ul><li>Decrease the risk of flawed data and ineffective research. </li></ul></ul><ul><ul><li>Integrate clinical standards with research standards. </li></ul></ul>
    19. 19. Understanding a protocol <ul><ul><li>Title of protocol </li></ul></ul><ul><ul><li>The Body System/ Disease Process/Behavior/Policy </li></ul></ul><ul><li>Intervention/Technique/Method/ </li></ul><ul><li>Instrument/Procedure </li></ul><ul><ul><li>Clinical research terms </li></ul></ul><ul><ul><li>Additional reading </li></ul></ul><ul><ul><li>Ask questions </li></ul></ul>
    20. 20. Understanding a protocol <ul><li>Title of the Protocol </li></ul><ul><ul><li>“A Multi-center, Randomized, Phase III Active Control Study Comparing ( investigational intervention ) and ( standard intervention ) in (subject population)” </li></ul></ul><ul><ul><ul><ul><li>Structure of the research </li></ul></ul></ul></ul>
    21. 21. Understanding a protocol <ul><li>“Walk the path of the researcher ” </li></ul><ul><li>Knowledge of the Body system/Disease process/Behavior/Policy </li></ul><ul><li>Knowledge of the Intervention/Technique/Method/ </li></ul><ul><li>Instrument/Procedure </li></ul>
    22. 22. Understanding a protocol <ul><ul><li>Additional Reading </li></ul></ul><ul><ul><ul><li>Duke Medical Center Library Online ( http://www.mclibrary.duke.edu ) </li></ul></ul></ul><ul><ul><li>Medline </li></ul></ul>
    23. 23. Understanding a protocol <ul><li>Defining research terms </li></ul><ul><ul><li>Get to know the context and intent </li></ul></ul><ul><ul><li>Protocol glossary (protocol specific) </li></ul></ul><ul><ul><li>CTQA coordinator guidebook (http://medschool.duke.edu/compliance) </li></ul></ul><ul><ul><li>Several online clinical research glossaries </li></ul></ul>
    24. 24. Understanding a protocol <ul><li>Speak up and ask questions </li></ul><ul><li>The protocol is not a perfect document . </li></ul><ul><li>Responsibility/Accountability </li></ul><ul><ul><li>Milgram experiment ( Obedience to Authority Study) </li></ul></ul><ul><ul><li>Genovese syndrome ( Bystander effect ) </li></ul></ul><ul><ul><li>The S einfeld finale (“Is Doing Nothing Something?”) </li></ul></ul><ul><ul><li>Healthcare professionals are held to a higher standard. </li></ul></ul>
    25. 25. Utilizing a protocol <ul><li>Research set-up </li></ul><ul><li>Reconciling </li></ul><ul><li>Explaining the research </li></ul>
    26. 26. Utilizing a protocol <ul><ul><ul><li>Example #1 </li></ul></ul></ul><ul><ul><ul><li>A coordinator is given a protocol written by a Duke investigator and it is his/her responsibility to obtain IRB approval and implement the research within the clinical setting. </li></ul></ul></ul>
    27. 27. Utilizing a protocol <ul><ul><ul><li>Example #1 </li></ul></ul></ul><ul><ul><ul><li>A coordinator is given a protocol written by a Duke investigator and it is his/her responsibility to obtain IRB approval and implement the research within the clinical setting. </li></ul></ul></ul><ul><ul><ul><li>The protocol becomes the map of the scientific/clinical details for writing the consent, creating the IRB summary and designing the structure of the research within the clinic (budget, facility needs, personnel, etc.) </li></ul></ul></ul>
    28. 28. Utilizing a protocol <ul><ul><ul><li>Example # 2 </li></ul></ul></ul><ul><ul><ul><li>Per the agreement for a pharmaceutically-sponsored protocol, the research has competitive enrollment. Once the overall target enrollment has been met via all sites, the study will end regardless of individual site enrollment numbers. This same protocol has details of long-term safety procedures that must be performed for early withdrawal. </li></ul></ul></ul>
    29. 29. Utilizing a protocol <ul><ul><ul><li>Example # 2 </li></ul></ul></ul><ul><ul><ul><li>Per the agreement for a pharmaceutically-sponsored protocol, the research has competitive enrollment. Once the overall target enrollment has been met via all sites, the study will end regardless of individual site enrollment numbers. This same protocol has details of safety procedures that must be performed for early withdrawal.. </li></ul></ul></ul><ul><ul><ul><li>The protocol becomes evidence that there is an inconsistency in the procedures for the research. </li></ul></ul></ul><ul><ul><ul><li>Questions that need to be addressed--What will happen to active subjects if the overall study is stopped? The safety procedures per the protocol are required….who will pay for these procedures if the study prematurely ends? </li></ul></ul></ul>
    30. 30. Utilizing a protocol <ul><ul><ul><li>Example # 3 </li></ul></ul></ul><ul><ul><ul><li>A nephrology protocol requires the use of a dialysis center and its staff. The staff will be asked to collect and document data per the normal dialysis visit for the research. </li></ul></ul></ul>
    31. 31. Utilizing a protocol <ul><ul><ul><li>Example # 3 </li></ul></ul></ul><ul><ul><ul><li>A nephrology protocol requires the use of a dialysis center and its staff. The staff will be asked to collect and document data per the normal dialysis visit for the research. </li></ul></ul></ul><ul><ul><ul><li>The coordinator becomes the instructor for the staff and the protocol becomes the textbook . </li></ul></ul></ul>
    32. 32. Utilizing a protocol <ul><ul><ul><li>Example # 4 </li></ul></ul></ul><ul><ul><ul><li>The sponsor of a protocol sends safety reports regarding adverse events at other sites. Several reports of pneumonia are detailed. Pneumonia was not documented as a possible adverse event for the research. </li></ul></ul></ul>
    33. 33. Utilizing a protocol <ul><ul><ul><li>Example # 4 </li></ul></ul></ul><ul><ul><ul><li>The sponsor of a protocol sends safety reports regarding adverse events at other sites. Several reports for pneumonia are detailed that was not listed as a possible adverse event for the research. </li></ul></ul></ul><ul><ul><ul><li>Comparing these reports to the protocol details the continuing occurrence of an unexpected adverse event that could also be study-related. </li></ul></ul></ul>
    34. 34. Utilizing a protocol <ul><ul><ul><li>Example # 5 </li></ul></ul></ul><ul><ul><ul><li>An OB-GYN research group is interested in a pharmaceutically-sponsored protocol involving cervical dysplasia. </li></ul></ul></ul>
    35. 35. Utilizing a protocol <ul><ul><ul><li>Example # 5 </li></ul></ul></ul><ul><ul><ul><li>An OB-GYN research group is interested in a pharmaceutically-sponsored protocol involving cervical dysplasia. </li></ul></ul></ul><ul><ul><ul><li>The objective of past protocols become the “research resume” for the group. </li></ul></ul></ul>
    36. 36. Summarize <ul><li>A protocol can seem intimidating. </li></ul><ul><li>Approach the protocol answering the 3 main questions. </li></ul><ul><li>Walk the path of the researcher. </li></ul><ul><li>Do some additional reading, define terms and ask questions. </li></ul><ul><li>Be acquainted with all the procedures required. </li></ul><ul><li>Learn to use the details of the protocol to help with set-up and explanation of the research. </li></ul>
    37. 37. Final Thoughts <ul><li>Not a nursing order </li></ul><ul><li>Overall understanding for an easier process </li></ul><ul><li>Scientific and Practical Review </li></ul>
    38. 38. Final Thoughts <ul><ul><ul><li>“ It’s the protocol, stupid!” </li></ul></ul></ul>
    39. 39. Contact Us: <ul><li>Clinical Trials Quality Assurance Section </li></ul><ul><li>Compliance Office--School of Medicine </li></ul><ul><li>2200 West Main Street </li></ul><ul><li>Suite 720 Wachovia Plaza at Erwin Square </li></ul><ul><li>Durham, NC 27705 </li></ul><ul><li>Sheda’s phone number: (919) 684-6456 </li></ul><ul><li>Sheda’s email: moori001@mc.duke.edu </li></ul><ul><li>Fax: (919) 684-6105 </li></ul><ul><li>Website: http://medschool.duke.edu/compliance </li></ul>
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