Informatics and Clinical Trials

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Informatics and Clinical Trials

• Marjorie Jeffcoat DMD
• University of Alabama
• University of Pennsylvania

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First you need a good idea

• Testable hypothesis
• Protocol development
• Needed approvals
• Develop manual of operations
• Develop necessary informatics

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The subject must be informed

• IRB approval
• Informed consent
• Risks and benefits
• Costs
• HIPPA
• who has access to the study data

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Patient locator

• Record the patient number
• Record the patient visit
• Record the date of the visit
• Check the version number of the form
• Record your initials
• Record address, phone number, etc.

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Oral Protocol Participant Locator Form  
Participant ID DATE
FORM VERSION
   Participant's Full Legal Name     First
__________________ MI _____ Last
____________________     Date of birth ___ - __ -
____     Mailing Address   _______________________
_______________________________      Telephone
Numbers   Home (__ __ __) __ __ __ - __ __ __
__   Work (__ __ __) __ __ __ - __ __ __
__   Other (__ __ __) __ __ __ - __ __ __ __  
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Tips for HIPPA

• Each subject should sign a HIPPA consent
• The patient locator information is critical to
  maintain, but the patient must know who may have
  access to the data
• Design the data base so all identifiers could be
  easily stripped for future use

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Manual of Operations
PERIODONTAL EXAMINATION PROCEDURE   EQUIPMENT mirr
or periodontal probe 2X2" sterile
gauze Detailed procedure
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Periodontal Examination B
  Consult Form "TOOTH COUNT" to determine the
random quadrants to be used for the random half
mouth periodontal evaluations. Be sure to
complete only those sections of the form that
pertain to the quadrants selected. However, if
the participant presents with fewer than 10
natural teeth the entire form should be
completed. Circle the appropriate response to
indicate which quadrants will be examined.  
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Your paper case report forms should match the
electronic data entry forms
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Paper Charts
Paper charts are available for chair-side
recording of periodontal measurements. One
measurement is taken on the buccal and lingual
surfaces for plaque index and gingival index. Six
measurements are taken on each tooth
(MB,M,DB,ML,L,DL) for attachment level. Separate
charts are used for the maxilla and mandible.
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Direct Software Entry
The PerioChart software is used for direct data
entry of missing teeth, plaque and gingival
indices, and probing attachment level. Consult
the PerioChart section of this manual for
instructions on how to utilize PerioChart. The
PerioChart software will automatically generate a
chart on the screen and the assistant will use
the keyboard and/or mouse to input data. The
software will also track who is responsible for
the data. The Periochart program described below
will provide direct data entry, print-out and
back-up of these data.
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Direct software entry

• Training
• Checking the data
• Backups
• File formats

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Direct entry from an instrument

• Repeatability
• Validity
• Reliability

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All examiners must be calibrated

• Understanding the standard operating procedures
  (manual of operations)
• Validation relative to a gold standard examiner
• Repeatability

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Capture every phase of the study
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Radiographic Examination  
  The purpose of this form is confirm the proper
radiographs are taken.    1. Posterior
standardized vertical bite wings of satisfactory
quality taken of each study site?   YES
................. 1 NO ................ 2
specify reason ______________________   2.
Posterior standardized vertical bite wings of
satisfactory quality taken of each study site
mounted and labelled?   YES ................. 1 N
O ................ 2 specify reason
______________________  
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Plan for the statistical analysis
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Do not forget the source document
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Plan for problems
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Thank you