HHDDCLINICAL H HHDDRESEARCH H HHDDFOR H HHDDRESIDENT H HHDDEdited H&
Hformatted Hby:
Vittoriana HCrisera
Journal HManager, HJournal Hof HHealth
HSpecialties H Saudi HCommission Hfor HHealth
HSpecialties H Riyadh, HSaudi HArabia
The HSaudi HCommission Hfor HHealth HSpecialties
The HDepartment Hof HMedical HEducation H& HPostgraduate HStudies
Read
Evaluate
H
Study
H
Experiment
H
Apply
H
Revise
H
Circumstantiate
Harness
H
2014
,Prepared H by
Hani HTamim, HPhD
Associate HProfessor, HDepartment Hof HInternal HMedicine
H Director, HBiostatistics HUnit, HClinical HResearch
HInstitute H Director, HFellowship Hand HResidency
HResearch HProgram H American HUniversity Hof HBeirut
HMedical HCenter
Beirut, H Lebanon
Reviewed H by:
Haroutune H Armenian, H MD, H DrPH
Professor H in H Residence H at H the H UCLA
Professor HEmeritus Hof HEpidemiology Hat HJohns HHopkins HBloomberg HSchool Hof HPublic
HHealth H Los HAngeles, HUSA
Mohammed H Al H Onazi, H MD
Consultant HPediatric HSurgeon, HDepartment Hof HPediatric HSurgery
H Prince HSultan HMilitary HMedical HCity
Medical HEducation HConsultant, HSaudi HCommission Hfor HHealth HSpecialties
H Riyadh, HSaudi HArabia
Saud HAl HShanafey, HMD, HMSc, HMBA, HFRCSC
Deputy HExecutive HDirector HAcademic H& HTraining
HAffairs H Associate HProfessor H& HConsultant,
HPediatric HSurgeon H King HFaisal HSpecialist
HHospital H& HResearch HCenter
Medical HEducation HConsultant, HSaudi HCommission Hfor HHealth HSpecialties
H Riyadh, HSaudi HArabia
Edited H& Hformatted Hby:
Vittoriana HCrisera
Journal HManager, HJournal Hof HHealth
HSpecialties H Saudi HCommission Hfor HHealth
HSpecialties H Riyadh, HSaudi HArabia
© HSaudi HCommission Hfor HHealth HSpecialties, H2014
King H Fahd H National H Library H Cataloging-in-Publication H Data
Saudi HCommission Hfor HHealth HSpecialties H- HRiyadh
H2014 H Introduction Hto HClinical HResearch Hfor
HResidents
92p, H14.8cm×21cm
H ISBN: H978-9960-9832-
9-5
1. Clinical Hmedicine H- HDiagnosis I-Title
616.075 Hdc 1435/9120
H L.D.no. H 1435/9120
ISBN: H 978-9960-9832-9-5
,Preface .................................................................................................................................................. 1
Section H1: HOverview Hof Hthe Hresearch Hprocess ................................................................ 2
1. What His Hresearch 2
2. Steps Hin Hconducting Hresearch 2
Section H2: HFormulating Ha Hresearch Hquestion .................................................................. 5
1. What His Ha Hresearch Hquestion 5
2. Criteria Hof Ha Hgood Hresearch Hquestion 5
3. Sources Hof Hresearch Hquestions 5
4. Elements Hof Ha Hresearch Hquestion 5
5. Criteria Hfor Ha Hbad Hresearch Hquestion 6
6. Example Hof Ha Hresearch Hquestion 6
Section H3: HConducting Han Heffective Hliterature Hreview............................................... 7
1. Definition Hof Ha Hliterature Hreview 7
2. The Haim Hof Ha Hliterature Hreview 7
3. Characteristics Hof Ha Hgood Hliterature Hreview 7
4. Steps Hof Ha Hliterature Hreview 8
5. Conclusion 14
Section H4: HEndNote........................................................................................................................ 15
1. What His HEndNote 15
2. Introduction Hto Han HEndNote Hlibrary 16
3. To Hcreate Ha Hlibrary 16
4. Entering Hreferences Hinto Ha Hlibrary 16
5. Inserting Hreferences Hand Hgenerating Hbibliographies Hin HMicrosoft H Word 17
Section H5: HWriting Ha Hproposal ............................................................................................... 19
1. Definition Hof Ha Hresearch Hproposal 19
2. Aims Hof Ha Hresearch Hproposal 19
3. Sections Hof Ha Hresearch Hproposal 19
Section H6: HEthical Hissues Hand HIRB ........................................................................................ 24
1. Ethical H issues 24
2. IRB 25
Section H7: HData Hcollection, Hentry, Hcleaning Hand Hmanagement ............................. 27
1. General Hterms 27
2. Data H collection 28
iii
, 3. Database Hstructure 28
4. Data H entry 30
5. Data H cleaning 31
6. Data H management 32
Section H8: HDescriptive Hstatistics ............................................................................................ 33
1. Descriptive Hstatistics Hfor Hcategorical Hvariables 33
2. Descriptive Hstatistics Hfor Hcontinuous Hvariables 35
Section H9: HInferential Hstatistics ............................................................................................... 38
1. Definition 38
2. Probability H distributions 38
3. Types Hof Hinferential Hstatistics 39
4. General Hrule Hfor Hnormal Hdistributions 41
5. Different Hstatistical Htests 41
6. Sample Hsize Hcalculation 42
Section H10: HMeasures Hof Heffect ............................................................................................... 43
1. Absolute Hrisk 43
2. Relative H risk 43
3. Risk H difference 44
Section H11: HOverview Hof Hstudy Hdesigns............................................................................ 45
1. Observational Hstudies 45
2. Experimental Hstudies 46
3. General Hterms 46
4. Biases Hin Hclinical Hresearch 48
Section H12: HCross-sectional Hdesign ........................................................................................ 50
1. Definition 50
2. Choosing Ha Hrepresentative Hsample 51
3. Strengths Hand Hlimitations 51
Section H13: HCase Hcontrol Hstudy Hdesigns ............................................................................ 53
1. Definition 53
2. Identifying H cases 53
3. Identifying H controls 54
4. Exposure Hassessment 54
5. Matching 54
6. Analysis 55
7. Strengths Hand Hlimitations 56
iv