RESEARCH
SYSTEMATIC INVESTIGATION TO ESTABLISH
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FACTS
IMPORTANT TOOL TO HELP DEVELOP SOLUTION
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TO BENEFIT PEOPLE ALL OVER THE WORLDIDENTIFICATION OF BETTER WAYS TO
PREVENT,DIAGNOSE,TREAT AND UNDERSTAND
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HUMAN DISEASESTREATMENT? CARE PROVIDED TO IMPROVE A
SITUATION OR DISEASE
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CLINICAL TRIAL
RESEARCH STUDY THAT TESTS HOW WELL AN
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INTERVENTION WORKS IN A GROUP OF PEOPLETESTS NEW METHODS OF
SCREENING,PREVENTTION DIAGNOSIS OR
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THERAPY
CONDUCTED IN PHASES
ANSWERS SCIENTIFIC QUESTIONS
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ETHICAL
ELEMENTS AND PRINCIPLES
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PROTOCOLPROTOCOL REVIEW
SPONSORS
ELIGIBILITY CRITERIA
INFORMED CONSENT
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TYPES OF CLINICAL TRIALSPHASES OF CLINICAL TRIALS
WHO CAN PARTICIPATE IN CLINICAL TRIALS ?
INCLUSION AND EXCLUSION CRITERIA
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IMPORTANCE OF ETHICS IN CLINICAL TRIALS
PROTOCOL
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PLAN OR ACTION PLANWHO IS ELIGIBLE
DETAILS ABOUT TEST,PROCEDURES
LENGTH OF STUDY
WHAT INFORMATION WILL BE GATHERED
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LED BY PRINCIPAL INVESTIGATORPROTOCOL REVIEW
APPROVAL BY INSTITUITIONAL REVIEW BOARD
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OR IRB,ETHICAL COMMITTEESURGEONS,STATISTICIANS,OTHER MEMBERS
ENSURES ETHICS AND RIGHTS OF ALL
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PARTICIPANTS
SPONSOR
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FOUNDATIONSMEDICAL INSTITUIIONS
SURGEON
VOLUNTARY GROUPS
PHARMA COMPANIES
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OTHER FEDERAL AGENCIESELIGIBILITY CRITERIA
GUIDELINES WHO CAN OR CAN'T PARTICIPATE
CHARACTERISTICS THAT MUST BE MINIMALLY
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SHARED BY ALL PARTICIPANTS
AGE
GENDER
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MEDICAL HISTORYCURRENT HEALTH STATUS,LAB VALUES
INFORMED CONSENT
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PROCESS OF PROVIDING POTENTIALPARTICIPANTS WITH IMPORTANT FACTS ABOUT
A CLINICAL TRIAL BEFORE THEY DECIDE TO
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PARTICIPATE
NOT A CONTRACT OR PIECE OF PAPER
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PROCESSIN PARTICIPANTS NATIVE LANGUAGE
AT AN APPROPRIATE EDUCATIONAL LEVEL
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RESEARCH TEAM PROVIDES AN INFORMEDCONSENT DOCUMENT THAT INCLUDES DETAILS
LIKE
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PURPOSE OF STUDY
DURATION
REQUIRED PROCEDURE
EXPLANATION OF RISK,BENEFIT
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WHO TO CONTACTPARTCIPANT DECIDES WHETHER TO SIGN OR
NOT
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AFTER SIGNING,NOT BOUNDIF UNCOMFORTABLE AT ANY POINT,CAN
WITHDRAW
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TYPES OF CLINICAL TRIALS
TREATMENT--NEW APPROCH TO SURGERY
PREVENTION
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DIAGNOSTICSCREENING
QUALITY OF LIFE--EXPLORE WAYS TO IMPROVE
COMFORT AND QOL WITH CHRONIC ILLNESS
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WHAT HAPPENS IN A TRIAL?CLINICAL TRIAL COMPARE A NEW MANAGEMENT
STRATEGY OR SURGICAL TECHNIQUE WITH
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ANOTHER THAT ALREADY EXISTS.
THIS DETERMINES IF NEW ONE IS AS SUCCESSFUL
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OR BETTER THAN EXISTING ONE.RANDOMIZATION IS DONE WHEN TWO OR
MORE ALTERNATIVE TREATMENTS ARE
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ASSIGNED TO VOLUNTEERS BY CHANCE INSTEAD
OF CHOICE.
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SINGLE BLINDDOUBLE BLIND STUDY
WHO CAN PARTICIPATE?
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INCLUSION CRITERIA? FACTORS THAT ALLOWTO PARTICIPATE.
EXCLUSION CRITERIA--- FACTORS THAT DO NOT
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ALLOW PARTICIPATION
AGE
GENDER
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TYPE AND STAGE OF DISEASESPECIFIC LAB VALUES
OTHER MEDICAL CONDITIONS
NOT PERSONAL
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IDENTIFY APPROPRIATE PARTICIPANTSKEEP THEM SAFE
APPROPRIATE ANSWER TO
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QUESTION/HYPOTHESIS
ETHICS
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RESPECT FOR PERSONSBENEFICENCE--TO DO GOOD,TO DO NO HARM
JUSTICE OR FAIRNESS
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RESPECTRIGHT TO MAKE THEM OWN CHOICES
FACTS PRESENTED PROPERLY
NO PRESSURE
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COMMUNITY RESPECTEDCAB--COMMUNITY ADVISORY BOARD
BENEFICENCE
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RESEARCH SHOULD NOT HARM PARTICIPANTSLOW RISK
MORE BENEFITS
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JUSTICEFAIRLY RECRUITED AS RESEARCH PARTICIPANTS
NO FAVOUR TO PARTICULAR,ALL EQUAL
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WHO IS RESPONSIBLE?
ETHICAL COMMITTEE OR INSTITUITIONAL
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REVIEW BODYREVIEW PROTOCOL
ASK TO CHANGE PROTOCOL WHEN NEEDED
SUPERVISE- BEGINNING TO END
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OVERSEE SCIENTIFIC DESIGNREVIEW COMMUNITY INTEREST
ENFORCE INFORMED CONSENT
ENFORCE CONFIDENTIALITY
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ETHICAL COMMITTEE
MEMBERS WITH SCIENCE BACKGROUND
MEMBERS WITHOUT SCIENCE BACKGROUND
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RELIGION OR COMMUNITY LEADERSPEOPLE WHO PARTICIPATED EARLIER
CLEAR UNDERSTANDING WHEN TO TAKE
SECOND OPINION
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FORMULATE HYPOTHESIS