Informatics and Clinical Trials

Marjorie Jeffcoat DMDMarjorie Jeffcoat DMD

University of AlabamaUniversity of Alabama

University of PennsylvaniaUniversity of Pennsylvania

First you need a good idea

Testable hypothesisTestable hypothesis Protocol developmentProtocol development Needed approvalsNeeded approvals Develop manual of Develop manual of

operationsoperations Develop necessary Develop necessary

informaticsinformatics

The subject must be informed

IRB approvalIRB approval Informed consentInformed consent Risks and benefitsRisks and benefits CostsCosts HIPPAHIPPA who has access to the who has access to the

study datastudy data

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.

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 : (__ __ __) __ __ __ - __ __ __ __ 

Tips for HIPPA

Each subject should sign a HIPPA consentEach subject should sign a HIPPA consent The patient locator information is critical to The patient locator information is critical to

maintain, but the patient must know who maintain, but the patient must know who may have access to the datamay have access to the data

Design the data base so all identifiers could Design the data base so all identifiers could be easily stripped for future usebe easily stripped for future use

Manual of Operations

PERIODONTAL EXAMINATION PROCEDURE EQUIPMENTmirrorperiodontal probe2X2" sterile gauze

Detailed procedure

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.  

Your paper case report forms should match the electronic data

entry forms

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.

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.

Direct software entry

Training Training Checking the dataChecking the data BackupsBackups File formatsFile formats

Direct entry from an instrument

RepeatabilityRepeatability ValidityValidity ReliabilityReliability

All examiners must be calibrated

Understanding the standard operating Understanding the standard operating procedures (manual of operations)procedures (manual of operations)

Validation – relative to a gold standard Validation – relative to a gold standard examinerexaminer

RepeatabilityRepeatability

Capture every phase of the study

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 ................. 1NO ................ 2 specify reason ______________________ 2. Posterior standardized vertical bite wings of satisfactory quality taken of each study site mounted and labelled? YES ................. 1NO ................ 2 specify reason ______________________ 

Plan for the statistical analysis

Do not forget the source document

Plan for problems