Informatics and Clinical Trials Marjorie Jeffcoat DMD University of Alabama University of Pennsylvania

First you need a good idea Testable hypothesis Protocol development Needed approvals Develop manual of operations Develop necessary informatics

The subject must be informed IRB approval Informed consent Risks and benefits Costs HIPPA who has access to the study 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 consent 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 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 Design the data base so all identifiers could be easily stripped for future use

Manual of Operations PERIODONTAL EXAMINATION PROCEDURE EQUIPMENT mirror periodontal probe 2X2" 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 data Checking the data Backups Backups File formats File formats

Direct entry from an instrument Repeatability Repeatability Validity Validity Reliability Reliability

All examiners must be calibrated Understanding the standard operating procedures (manual of operations) Understanding the standard operating procedures (manual of operations) Validation – relative to a gold standard examiner Validation – relative to a gold standard examiner Repeatability Repeatability

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

Plan for the statistical analysis

Do not forget the source document

Plan for problems