The coordination of clinical research: a handbook for research coordinators
Gespeichert in:
| Weitere Verfasser: | , |
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| Format: | Buch |
| Sprache: | English |
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Stuttgart
Thieme
[2020]
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| Beschreibung: | xx, 320 Seiten 35 Illustrationen 24.2 cm x 17.5 cm |
| ISBN: | 9783132422292 3132422290 |
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| 245 | 1 | 0 | |a The coordination of clinical research |b a handbook for research coordinators |c Mohit Bhandari, MD, PhD, FRCSC, Esther M. M. Van Lieshaout, MSc, PhD |
| 264 | 1 | |a Stuttgart |b Thieme |c [2020] | |
| 264 | 4 | |c © 2020 | |
| 300 | |a xx, 320 Seiten |b 35 Illustrationen |c 24.2 cm x 17.5 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
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| 689 | 0 | 1 | |a Koordination |0 (DE-588)4032393-6 |D s |
| 689 | 0 | |5 DE-604 | |
| 700 | 1 | |a Bhandari, Mohit |0 (DE-588)136998356 |4 edt | |
| 700 | 1 | |a Lieshout, Esther M. M. van |0 (DE-588)1204449139 |4 edt | |
| 710 | 2 | |a Georg Thieme Verlag KG |0 (DE-588)1064287301 |4 pbl | |
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Datensatz im Suchindex
| _version_ | 1805087101307322368 |
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| adam_text |
CONTENTS
PREFACE
.
XV
ACKNOWLEDGMENTS
.
XVI
CONTRIBUTORS
.
XVII
PART
I
GETTING
STARTED
.
1
ESTHER
M.
M.
VAN
LIESHOUT,
PARAG
SANCHETI
1
LEADERSHIP
AND
MANAGEMENT:
THE
PRINCIPAL
INVESTIGATOR
AND
RESEARCH
COORDINATOR
.
2
HEATHER
DWYER
1
LEADERSHIP
AND
MANAGEMENT:
THE
PRINCIPAL
INVESTIGATOR
AND
RESEARCH
COORDINATOR
.
2
HEATHER
DWYER
1.1
INTRODUCTION
.
2
1.5
COMMUNICATING
WITH
STAFF
.
6
1.2
LEADERSHIP
STYLES
.
2
1.5.1
COMMUNICATION
STRATEGIES
.
6
1.2.1
AUTOCRATIC
LEADERS
.
2
1.5.2
COMMUNICATING
WITH
1.2.2
DEMOCRATIC
LEADERS
.
3
EXTERNAL
STAFF
.
7
1.2.3
LAISSEZ-FAIRE
LEADERSHIP.
3
1.5.3
RELATIONSHIP/TEAM
BUILDING
.
7
1.3
BUILDING
A
MOTIVATIONAL
1.6
ORGANIZATION
.
8
WORKPLACE
.
3
1.6.1
DOCUMENTATION
.
8
1.3.1
EMOTIONAL
INTELLIGENCE
.
3
1.6.2
TIME
MANAGEMENT
.
8
1.3.2
PHYSICAL
ENVIRONMENT
.
4
1.7
MANAGEMENT
COMPETENCE
.
.
10
1.3.3
MANDATES
AND
VISION
.
4
1.7.1
MANAGING
UP
AND
MANAGING
1.4
MENTORING
NEW
STAFF
.
4
DOWN
.
10
1.4.1
ORIENTATION
.
4
1.7.2
PROFESSIONAL
DEVELOPMENT
.
.
10
1.4.2
MENTORING
.
5
1.8
CONCLUSION
.
.
11
1.4.3
PERFORMANCE
REVIEWS
.
6
2
ROLES:
WHY
A
RESEARCH
COORDINATOR
IS
CRITICAL
.
.
12
KELLY
TRASK
2.1
INTRODUCTION
.
.
12
2.2.2
DATA
MANAGEMENT
.
.
17
2.1.1
WHY
A
RESEARCH
COORDINATOR
IS
2.2.3
STUDY
PLANNING,
COORDINATION,
AND
NECESSARY
.
.
12
ADMINISTRATION
.
.
18
2.1.2
EDUCATION
AND
CERTIFICATION
.
.
13
2.2.4
FURTHER
TASKS
.
.
20
2.1.3
DELEGATION
OF
DUTIES
.
.
14
2.3
PRACTICAL
APPLICATION
.
20
2.2
DUTIES
.
.
15
2.4
CONCLUSION
.
22
2.2.1
STUDY
PARTICIPANT
CARE
.
.
16
3
HIRING:
CHARACTERISTICS
OF
A
HIGHLY
QUALIFIED
RESEARCH
COORDINATOR
.
MILENA
R.
VICENTE
.
.
24
3.1
INTRODUCTION
.
.
24
3.2
DESIRABLE
CHARACTERISTICS
.
.
29
3.1.1
THE
RESEARCH
COORDINATOR
ROLE
.
.
24
3.2.1
COMMUNICATION
SKILLS
.
.
29
3.1.2
THE
DECISION
TO
HIRE
.
.
24
3.2.2
TEAM
BUILDING
SKILLS
.
.
30
3.1.3
HIRING
PROCESS.
.
.
25
3.2.3
INTERPERSONAL
SKILLS
.
.
30
3.1.4
THE
INTERVIEW
.
.
28
3.2.4
POSITIVE
ATTITUDE
.
.
31
3.1.5
MAKING
A
DECISION
.
.
29
3.2.5
PROFESSIONAL
SKILLS
.
.
31
V
CONTENTS
3.2.6
REGULATORY
AND
ETHICS
GUIDELINES.
.
.
32
3.2.10
FINANCIAL
OR
GRANT
MANAGEMENT
.
34
3.2.7
COMPUTER
SKILLS
AND
PROJECT
3.3
THE
NEWLY
HIRED
RESEARCH
MANAGEMENT
.
.
33
COORDINATOR
.
35
3.2.8
CLINICAL
EXPERIENCE
.
.
34
3.4
CONCLUSION
.
35
3.2.9
WRITING
SKILLS
.
.
34
4
GROWTH:
FROM
0
TO
100,
REAL
QUICK!
37
NICOLE
M.
HARRIS,
DARREN
M.
ROFFEY
4.1
INTRODUCTION
.
.
37
4.7.2
WHO
WILL
APPROACH
THE
PATIENT?
.
44
4.2
PROTOCOL
DEVELOPMENT
.
.
37
4.7.3
WHEN
WILL
THE
PATIENT
BE
CONTACTED?.
.
.
44
4.3
INFORMED
CONSENT
FORM
.
.
39
4.7.4
WHERE
WILL
THE
PATIENT
BE
CONTACTED?
.
.
44
4.4
COMMUNICATION
.
.
39
4.7.5
HOW
WILL
PATIENT
CONTACT
OCCUR?
.
45
4.5
ENTHUSIASM
.
.
40
4.8
PRACTICAL
APPLICATION
.
45
4.6
TRAINING
.
4.8.1
DESIGNING
A
RECRUITMENT
PLAN
.
.
45
.
41
4.9
46
CONCLUSION
.
4.7
RECRUITMENT
.
.
42
4.7.1
IDENTIFYING
ELIGIBLE
PATIENTS
.
.
43
PART
II
WHAT
EVERY
RESEARCH
COORDINATOR
NEEDS
TO
KNOW
.
49
ERNESTO
GUERRA
FARFAN,
DINESH
KUMBHARE,
ANTHONY
ADILI
5
WHAT
IS
EVIDENCE-BASED
MEDICINE?
.
50
ELLIE
B.
M.
LANDMAN
5
WHAT
IS
EVIDENCE-BASED
MEDICINE?
.
50
ELLIE
B.
M.
LANDMAN
5.1
INTRODUCTION
.
50
5.4
WHERE
DO
WE
STAND
IN
EVIDENCE-
5.2
THE
HISTORY
OF
EVIDENCE-BASED
BASED
MEDICINE
TODAY?.
54
MEDICINE
.
50
5.4.1
CRITICISM
OF
EVIDENCE-BASED
5.3
PRINCIPLES
OF
EVIDENCE-BASED
MEDICINE
.
54
MEDICINE
.
51
5.4.2
CLINICAL
RESEARCH
.
55
5.3.1
BEST
AVAILABLE
EVIDENCE
.
51
5.5
PRACTICAL
APPLICATION
.
55
5.3.2
EVALUATE
AVAILABLE
EVIDENCE
.
52
5.5.1
CLINICAL
EXAMPLE
.
55
5.3.3
APPLICATION
OF
EVIDENCE
IN
THE
CARE
5.6
CONCLUSION
.
56
FOR
INDIVIDUAL
PATIENTS
.
53
6
RANDOMIZED
CONTROLLED
TRIALS.
58
MIRIAM
GARRIDO
CLUA
6.1
INTRODUCTION
.
58
6.5
RECRUITMENT
OF
STUDY
6.2
WHAT
IS
A
RANDOMIZED
CONTROLLED
PARTICIPANTS
.
63
TRIAL?
.
58
6.5.1
TIPS
FOR
COORDINATORS
.
63
6.2.1
STUDY
POPULATION
.
59
6.6
PARTICIPANT
ADHERENCE
.
64
6.2.2
RANDOMIZED
CONTROLLED
TRIAL
STUDY
6.7
ASSESSING
AND
REPORTING
ADVERSE
DESIGN
.
59
EVENTS
(AES)
.
64
6.2.3
RANDOM
ASSIGNMENT
6.7.1
MONITORING
A
RANDOMIZED
(RANDOMIZATION)
.
60
CONTROLLED
TRIAL
.
65
6.2.4
BLINDING
.
61
6.8
ETHICAL
CONSIDERATIONS
.
65
6.3
OUTCOME
MEASUREMENT
.
62
6.9 PRACTICAL
APPLICATION
.
66
6.3.1
RELIABILITY
AND
VALIDITY
OF
OUTCOMES
6.10
CONCLUSION
.
66
MEASURES
.
62
6.4
QUALITY
CONTROL
AND
DATA
COLLECTION
.
62
VI
CONTENTS
7.6
PERFORMING
THE
STUDY
.
75
7.6.1
INITIATION
PHASE
.
75
7.6.2
DATA
COLLECTION
.
75
7.6.3 PATIENT
INCLUSION
IN
PROSPECTIVE
STUDIES
.
76
7.6.4
KEEP
THE
STAFF
INFORMED
AND
COMMITTED
DURING
THE
STUDY
.
76
7.7
DATA
ANALYSIS
.
76
7.7.1
DEALING
WITH
CONFOUNDING
.
76
7.7.2
HANDLING
MISSING
OUTCOME
DATA
.
77
7.8
REPORTING
.
77
7.9
PRACTICAL
APPLICATION
.
78
7.9.1
BACKGROUND
.
79
7.9.2 STUDY
OBJECTIVE
.
79
7.9.3 STUDY
DESIGN.
79
7.9.4
PATIENTS
.
79
7.9.5
TREATMENT
.
79
7.9.6
STUDY
OUTCOMES
AND
OTHER
PARAMETERS
.
79
7.9.7
SAMPLE
SIZE
.
79
7.9.8 STATISTICAL
ANALYSIS
.
80
7.9.9
ETHICAL
CONSIDERATIONS
.
80
7.10
CONCLUSION
.
80
81
7
OBSERVATIONAL
STUDIES
.
PIETA
KRIJNEN
7.1
INTRODUCTION
.
68
7.2
TYPES
OF
OBSERVATIONAL
STUDIES
.
68
7.2.1
COHORT
STUDIES
.
68
7.2.2
CASE-CONTROL
STUDIES
.
68
7.2.3
CASE
SERIES
.
69
7.3
PROS
AND
CONS
OF
OBSERVATIONAL
STUDIES
.
69
7.4
TYPES
OF
BIAS
ASSOCIATED
WITH
OBSERVATIONAL
STUDIES
.
69
7.5
DESIGNING
OBSERVATIONAL
STUDIES
.
70
7.5.1
GENERAL
INFORMATION
.
70
7.5.2
DEFINE
RESEARCH
QUESTIONS
BASED
ON
A
LITERATURE
REVIEW
.
70
7.5.3
CHOOSE
THE
STUDY
DESIGN.
71
7.5.4
DEFINE
THE
STUDY
POPULATION
.
72
7.5.5
DESCRIBE
THE
TREATMENT
AND
PROCEDURES
.
72
7.5.6
DESCRIBE
THE
STUDY
PARAMETERS.
73
7.5.7 OUTCOMES
AND
OTHER
STUDY
PARAMETERS
.
73
7.5.8
STUDY
PROCEDURE
.
74
7.5.9
STATISTICAL
ANALYSIS
PLAN
.
74
7.5.10
ETHICAL
CONSIDERATIONS/DATA
HANDLING
.
74
8
SURVEYS
MIRIAM
GARRIDO
CLUA
8.1
INTRODUCTION
.
81
8.1.1
WHAT
IS
A
SURVEY
STUDY?.
81
8.2
RESEARCH
METHODS
.
82
8.2.1
QUESTIONNAIRES
.
82
8.2.2
FACE-TO-FACE
INTERVIEWS
.
83
8.2.3
TELEPHONE
INTERVIEWS
.
83
8.3
SELECTING
THE
SURVEY
METHOD.
.
84
8.3.1
POPULATION
.
84
8.3.2
RESEARCH
QUESTION
.
84
8.3.3
CONTENT
OF
THE
STUDY
.
85
8.3.4
BIAS
ISSUES.
85
8.3.5
RESOURCES
.
85
8.4
SAMPLE
AND
SAMPLING
.
85
8.4.1
RANDOM
SAMPLING
.
86
8.4.2
NONRANDOM
SAMPLING
.
86
8.5
RESEARCH
TOOL
DESIGN
.
86
8.5.1
TYPES
OF
QUESTIONS
.
86
8.5.2
QUESTIONNAIRE
LAYOUT
.
87
8.5.3 QUESTION
WORDING
.
88
8.5.4
QUESTION
ORDER
.
88
8.6
TRAINING
THE
INTERVIEWERS
.
88
8.7
PILOT
TESTING
.
89
8.8
TRANSLATION
.
89
8.9
RELIABILITY
AND
VALIDITY
.
90
8.10
ANALYSIS
OF
SURVEY
DATA
.
90
8.11
ETHICS
OF
SURVEY
RESEARCH
.
90
8.12
PRACTICAL
APPLICATION
.
91
8.13
CONCLUSION
.
92
VII
CONTENTS
9
QUALITATIVE
STUDIES
.
PATRICIA
SCHNEIDER
9.1
OBJECTIVES
.
94
9.2
INTRODUCTION
.
94
9.2.1
WHY
QUALITATIVE
RESEARCH?.
94
9.2.2
WHAT
IS
QUALITATIVE
RESEARCH?
.
94
9.2.3
QUALITATIVE
VERSUS
QUANTITATIVE
RESEARCH
.
94
9.2.4
ADVANTAGES
OF
QUALITATIVE
RESEARCH
.
94
9.3
DESIGNING
AND
CONDUCTING
THE
STUDY
.
95
9.3.1
GENERAL
STUDY
DETAILS
.
95
9.3.2
RESEARCH
QUESTION
.
95
9.3.3
RESEARCH
OBJECTIVES
.
95
9.4
STUDY
METHODS
.
95
9.4.1
ETHNOGRAPHY
.
95
9.4.2 GROUNDED
THEORY
.
95
9.4.3
PHENOMENOLOGY
.
95
9.5
SAMPLING
.
95
9.5.1
PURPOSIVE
SAMPLING
.
96
9.5.2 QUOTA
SAMPLING
.
96
9.5.3
CHAIN-REFERRAL
(SNOWBALL)
SAMPLING
.
96
9.6
SAMPLE
SIZE
. .
96
9.7
QUALITATIVE
DATA
COLLECTION
.
97
9.7.1
OBSERVATION
.
97
9.7.2
INTERVIEW
.
97
9.7.3
FOCUS
GROUP
.
97
9.7.4
DISCUSSION
GUIDE/LNTERVIEW
SCRIPT
DEVELOPMENT
.
98
9.7.5
INTERVIEW/FOCUS
GROUP
QUESTION
DEVELOPMENT
.
99
9.7.6
COLLECTING
INITIAL
DEMOGRAPHIC
DETAILS
.
99
9.7.7
OBTAINING
ADEQUATE
RESPONSES
.
99
9.7.8
TRANSCRIPTION
OF
INTERVIEWS
AND
FOCUS
GROUPS
.
100
9.8
DATA
ANALYSIS
AND
INTERPRETATION
.
100
10
PRINCIPLES
OF
GOOD
CLINICAL
PRACTICE
NAVEEN
KHAN
10.1
INTRODUCTION
.
109
10.2
HISTORY
OF
GOOD
CLINICAL
PRACTICE
.
109
10.2.1
REVISITING
A
DRASTICALLY
DIFFERENT
ERA
OF
CLINICAL
STUDIES
.
109
10.3
THE
HISTORY
OF
GCP
GUIDELINES
.
110
.
94
9.8.1
QUALITATIVE
DATA
ANALYSIS
APPROACHES
.
100
9.8.2
QUALITATIVE
DATA
CODING
.
100
9.8.3
DATA
MANAGEMENT
SOFTWARE
.
101
9.9
REPORTING
AND
DISSEMINATING
THE
STUDY
.
101
9.9.1
WHERE
TO
PUBLISH?
.
102
9.9.2
AUTHORSHIP
.
102
9.10
ETHICAL
IMPLICATIONS
.
102
9.10.1
INFORMED
CONSENT
.
102
9.10.2
PROTECTING
CONFIDENTIALITY
.
102
9.11
OTHER
CONSIDERATIONS
.
102
9.11.1
GENERALIZABILITY
.
102
9.11.2
AMBIGUITIES
.
102
9.11.3
FREQUENCY
.
103
9.12
TYPES
OF
BIAS
ASSOCIATED
WITH
QUALITATIVE
STUDIES
.
103
9.12.1
STRATEGIES
FOR
MANAGING
BIAS
.
103
9.13
PRACTICAL
APPLICATION
.
103
9.13.1
BACKGROUND
.
103
9.13.2
STUDY
OBJECTIVE
.
104
9.13.3
STUDY
DESIGN.
104
9.13.4
PARTICIPANTS
.
104
9.13.5
DISCUSSION
GUIDE
.
104
9.13.6
SAMPLE
SIZE
.
104
9.13.7
ETHICAL
CONSIDERATIONS
.
104
9.13.8
ANALYSIS
.
105
9.13.9
REPORTING
.
105
9.14
CONCLUSION
.
105
9.15
APPENDIX
A:
COLLABORATIVE
RESEARCH
FOCUS
GROUP
DISCUSSION
GUIDE
.
107
9.15.1
WELCOME,
INTRODUCTIONS,
AND
INFORMED
CONSENT
.
107
9.15.2
DISCUSSION
TOPICS
.
107
AND
RESEARCH
CONDUCT
.
109
10.4
THE
ICH-GCP
GUIDELINES
.
111
10.4.1
INTRODUCTION
AND
MAJOR
PRINCIPLES.
111
10.4.2
ROLES
AND
RESPONSIBILITIES
OF
INVOLVED
PARTIES
.
ILL
10.4.3
ESSENTIAL
DOCUMENTS
.
113
VIII
CONTENTS
BREGJE
].
W.
THOMASSEN,
MICHEL
SOUROUR,
KESH
REDDY
10.4.4
ADVANTAGES
OF
THE
ICH-GCP
10.5.2 TECHNOLOGICAL
ADVANCEMENTS
.
.
116
GUIDELINES
.
115
10.6
PRACTICAL
APPLICATION
.
.
116
10.5
FUTURE
DIRECTIONS
AND
10.6.1
GOOD
CLINICAL
PRACTICE
CHECKLIST
FOR
CHALLENGES
.
115
CLINICAL
RESEARCH
COORDINATORS
.
.
117
10.5.1
GLOBALIZATION
AND
THE
UNIVERSAL
10.7
CONCLUSION
.
.
117
ADOPTION
OF
GCP
.
115
PART
III
FROM
IDEA
TO
STUDY
START-UP
.
.
119
REBECCA
IVERS,
JACK
CHUN-YIU
CHENG
11
PRINCIPLES
OF
GRANT
WRITING:
TIPS
FOR
A
SUCCESSFUL
EXPERIENCE
.
.
120
MILENA
R.
VICENTE,
SARAH
DESJARDINS
11.1
INTRODUCTION
.
120
11.3
CONCLUSION
.
.
128
11.2
GETTING
STARTED
.
120
11.4
PRACTICAL
APPLICATION
.
.
128
11.2.1
START
EARLY
.
120
11.4.1
COMMON
ISSUES
THAT
RESULT
IN
GRANT
REJECTION.
.
129
12
DOLLARS
AND
*
SENSE
*
:
A
GUIDE
TO
RESEARCH
FINANCES
.
.
130
JOHANNA
DOBRANSKY,
DARREN
M.
ROFFEY
12.1
INTRODUCTION
.
130
12.2.9
NEED
FOR
A
CONTINGENCY
BUDGET
.
.
134
12.2
PLANNING
AND
CREATING
A
12.2.10
PITFALLS
ASSOCIATED
WITH
BUDGETARY
RESEARCH
BUDGET
.
130
PLANNING
.
.
135
12.2.1
PREPLANNING
PHASE
.
130
12.3
ONGOING
MONITORING
OF
A
12.2.2
FUNDING
SOURCE
.
130
RESEARCH
BUDGET
.
.
135
12.2.3
CENTRALIZED
VERSUS
DECENTRALIZED
12.3.1
INVOICING
AND
PAYMENTS.
.
135
BUDGETARY
MANAGEMENT
.
131
12.3.2
AMENDING
THE
STUDY
BUDGET
.
.
136
12.2.4
FINANCIAL
LIFECYCLE.
131
12.4
STUDY
TERMINATION
.
.
136
12.2.5
PLANNING
THE
BUDGET
.
131
12.4.1
PREMATURE
STUDY
TERMINATION
.
.
136
12.2.6
KEY
EXPENSES
.
131
12.5
PRACTICAL
APPLICATION
.
.
136
12.2.7
DIRECT
AND
INDIRECT
COSTS
.
132
12.6
CONCLUSION
.
.
138
12.2.8
NEGOTIATING
THE
STUDY
BUDGET
.
132
13
MAINTAINING
RECORDS
AND
THE
TRIAL
MASTER
FILE
.
.
143
ALISHA
GARIBALDI
13.1
INTRODUCTION
.
143
13.1.6
WHEN
THE
METHODS
CENTER
IS
ALSO
A
13.1.1
WHAT
IS
A
TRIAL
MASTER
FILE?
.
143
PARTICIPATING
CLINICAL
SITE
.
.
152
13.1.2
WHY
ALL
OF
THE
DOCUMENTATION?
.
149
13.1.7
DO
1
REALLY
NEED
A
BINDER?
.
.
152
13.1.3
SETTING
UP
A
TRIAL
MASTER
FILE
AT
A
13.1.8
SPOTLIGHT:
THE
CLINICAL
SITE
MANUAL
.
.
152
PARTICIPATING
CLINICAL
SITE
.
149
13.1.9
INTERNAL
AUDITS
.
.
153
13.1.4
SETTING
UP
A
TRIAL
MASTER
FILE
AT
A
13.1.10
PRACTICAL
APPLICATION
.
.
153
METHODS
CENTER
.
151
13.2
CONCLUSION
.
.
154
13.1.5
DOCUMENT
CONTROL
AND
THE
TRIAL
MASTER
FILE
.
152
14
ETHICS
SUBMISSIONS
.
.
155
14.1
INTRODUCTION
.
.
155
14.1.3
REVIEW
PROCESS
.
.
157
14.1.1
RESEARCH
ETHICS
COMMITTEE
.
.
155
14.1.4
MULTICENTER
HUMAN
STUDIES
AND
14.1.2
RESEARCH
ETHICS
COMMITTEE
INTERNATIONAL
STUDIES
.
.
159
SUBMISSION
.
.
157
14.2
CONCLUSION
.
.
160
IX
CONTENTS
15 THE
BASICS
OF
RESEARCH
CONTRACTS
.
CAROLINE
WOODS
15.1
INTRODUCTION
.
161
15.2
DIFFERENT
TYPES
OF
THE
AGREEMENTS
.
161
15.2.1
GRANT
FUNDING.
161
15.2.2
COLLABORATION
.
161
15.2.3
SITES.
162
15.2.4
INDUSTRY
INVOLVED
IN
INVESTIGATOR
INITIATED
STUDY
.
162
15.2.5
INDUSTRY-INITIATED
STUDY
AGREEMENT
.
162
15.3
THE
PARTS
OF
AN
AGREEMENT
.
162
15.3.1
THE
PARTIES
.
162
15.3.2
THE
PREAMBLE
.
163
15.3.3
THE
CLAUSES
.
163
16
HOW
TO
START-UP
A
STUDY
ELLIE
B.
M.
LANDMAN
16.1
INTRODUCTION
.
169
16.2
STUDY
START-UP
PHASE
.
169
16.2.1
IDENTIFY
AND
CONTACT
SITES
.
170
16.2.2
FEASIBILITY
.
171
16.2.3
CLINICAL
TRIAL
AGREEMENT
NEGOTIATION
. .
171
16.2.4
REGULATORY
AND
ETHICS
APPROVAL
.
172
16.2.5
SITE
INITIATION
VISIT
.
172
16.2.6
SITE
ACTIVATION
.
173
16.3
CHALLENGES
ENCOUNTERED
DURING
START-UP
.
173
.
161
15.3.4
SIGNATORIES
.
165
15.4
PRACTICAL
APPLICATION
.
165
15.4.1
EXAMPLES
OF
CLAUSES
.
165
15.5
STUDY
BUDGET
.
165
15.5.1
OVERVIEW
.
165
15.5.2
THE
TERMS
.
166
15.6
INTELLECTUAL
PROPERTY
.
166
15.6.1
OVERVIEW
.
166
15.6.2
THE
TERMS
.
166
15.7
PUBLICATION
CLAUSE
.
167
15.7.1
OVERVIEW
.
167
15.7.2
THE
TERMS
.
167
15.8
CONCLUSION
.
167
16.3.1
PROTOCOL
ADHERENCE
.
173
16.3.2
MEETING
RECRUITMENT
GOALS
.
173
16.3.3
DELAYING
FACTORS
.
174
16.3.4
GUIDELINES
FOR
GOOD
CLINICAL
PRACTICE
.
174
16.3.5
DRUG,
DEVICE,
OR
PROCEDURE
.
174
16.4 PRACTICAL
APPLICATION
.
174
16.5
KEYS
TO
SUCCESS
.
174
16.6
CONCLUSION
.
175
.
169
PART
IV
STUDY
EXECUTION
AND
CLOSE-OUT
.
177
AARON
NAUTH,
KIM
MADDEN,
PAUL
TORNETTA
17
SCREENING
AND
RECRUITING
PARTICIPANTS
.
178
NIENKE
WOLTERBEEK
17.1
INTRODUCTION
.
178
17.2
RECRUITMENT,
PRESCREENING,
AND
STUDY
SCREENING
.
178
17.3
BARRIERS
FOR
INCLUSION
.
179
17.4
ETHICAL
CONSIDERATIONS
.
179
17.5
HOW
TO
IMPROVE
RECRUITMENT
AND
SCREENING
.
180
17.5.1
TARGET
POPULATION
.
180
17.5.2
RECRUITMENT
PLAN
AND
CONTACT
METHODS
.
180
17.5.3
SCREENING
MECHANISM
.
182
17.5.4 STUDY
DESIGN.
182
17.6
PRACTICAL
APPLICATION
.
182
17.6.1
RECRUITMENT
.
184
17.6.2
PRESCREENING
PHASE
.
184
17.6.3
SCREENING
PHASE
.
185
17.7
CONCLUSION
.
185
X
CONTENTS
18
OBTAINING
INFORMED
CONSENT
.
187
CHANDNI
PATEL,
NAZANIN
BARKHORDARI
18.1
INTRODUCTION:
WHAT
IS
INFORMED
18.7
CONSENT
IS
AN
ONGOING
PROCESS.
.
190
CONSENT?
.
.
187
18.8
DECISION-MAKING
CAPACITY
.
190
18.2
THE
INFORMED
CONSENT
PROCESS
.
.
187
18.9
LANGUAGE
UNDERSTANDABLE
TO
THE
18.3
VOLUNTARY
CONSENT
.
.
188
PARTICIPANT
AND
THE
LEGALLY
18.4
CONSENT
SHOULD
BE
INFORMED
.
.
188
AUTHORIZED
REPRESENTATIVE
.
190
18.5
BASIC
ELEMENTS
OF
INFORMED
18.10
PRACTICAL
APPLICATION
.
191
CONSENT
.
.
188
18.11
CONCLUSION
.
192
18.6
PARTICIPANTS
MUST
BE
FREE
TO
WITHDRAW
.
.
189
19
COLLECTING
DATA:
PAPER
AND
ELECTRONIC
DATA
CAPTURE
SYSTEMS
.
193
ESTHER
M.
M.
VAN
LIESHOUT,
STEPHANIE
M.
ZIELINSKI
19.1
INTRODUCTION
.
.
193
19.7
DATASHEETS
ON
PAPER
VERSUS
19.2
THE
AIM
OF
DATA
COLLECTION
IN
A
ECRF
.
.
195
CLINICAL
STUDY
.
.
193
19.8
EXAMPLES
OF
AVAILABLE
EDCS
.
.
195
19.3
WHAT
DATA
SHOULD
BE
COLLECTED
.
.
193
19.9
CASE
REPORT
FORM
DESIGN
19.4
SOURCE
DATA
.
.
194
GUIDELINES
.
.
197
19.5
MULTIDISCIPLINARY
APPROACH
.
.
194
19.9.1
RESPONSE
TYPES
AND
CODING
.
.
199
19.6
CASE
REPORT
FORMS,
REMOTE
DATA
ENTRY,
AND
ELECTRONIC
DATA
CAPTURE
.
.
194
19.10
CONCLUSION
.
.
199
20
FOLLOW-UP:
WHY
IT
IS
IMPORTANT
AND
HOW
TO
MINIMIZE
LOSS
TO
FOLLOW-UP
.
STEPHANIE
L.
TANNER
.
203
20.1
INTRODUCTION
.
.
203
20.4.1
STUDY
DESIGN
STRATEGIES
.
.
205
20.2
WHY
IS
FOLLOW-UP
IMPORTANT?
.
.
203
20.4.2 METHODS
CENTER/SPONSOR
STUDY
.
207
.
207
20.3
WHY
ARE
PARTICIPANTS
LOST
TO
FOLLOW-UP
(WHY
DO
PATIENTS
LEAVE
A
STUDY)?
.
.
204
20.4.3
MANAGEMENT
.
LOCAL
SITE
STUDY
MANAGEMENT
TO
MAINTAIN
FOLLOW-UP
.
.
211
20.4
.
205
20.4.4
20.5
RETENTION
STRATEGIES.
PRACTICAL
APPLICATION
.
STRATEGIES
TO
MINIMIZE
LOSS
TO
FOLLOW-UP
.
.
212
20.6
CONCLUSION
.
.
212
21
HOW
TO
CLOSE
OUT
A
STUDY
.
KELLY
TRASK
.
.
214
21.1
INTRODUCTION
.
.
214
21.5.1
CLOSING
THE
STUDY
WITH
THE
ETHICS
21.2
REASONS
FOR
STUDY
CLOSURE
.
.
214
COMMITTEE
.
.
217
21.3
THE
PROCESS
OF
STUDY
CLOSURE.
.
.
215
21.6
RECORD
RETENTION
.
.
217
21.3.1
PREPARING
FOR
THE
CLOSEOUT
VISIT
.
.
215
21.7
AFTER
THE
STUDY
CLOSURE
.
.
218
21.4
THE
CLOSEOUT
VISIT
.
.
216
21.8
PRACTICAL
APPLICATION
.
.
219
21.4.1
WHAT
IF
THERE
ISN
*
T
A
CLOSEOUT
VISIT?
.
.
217
21.9
CONCLUSION
.
.
219
21.5
AFTER
THE
CLOSEOUT
VISIT
.
.
217
XI
CONTENTS
ANNEMIEKE
I.
J.
M.
SCHELLEVIS-MINTIENS,
ESTHER
M.
M.
VAN
LIESHOUT
22
KNOWLEDGE
DISSEMINATION:
GETTING
THE
WORD
OUT!
.
CHERYL
KREVIAZUK,
DARREN
M.
ROFFEY
.
222
22.1
INTRODUCTION
.
222
22.1.5
NONTRADITIONAL
KNOWLEDGE
22.1.1
KNOWLEDGE
DISSEMINATION
.
222
DISSEMINATION
.
.
227
22.1.2
MAXIMIZING
UPTAKE
OF
KNOWLEDGE
DISSEMINATION
.
223
22.1.6
TRADITIONAL
VERSUS
NONTRADITIONAL
KNOWLEDGE
DISSEMINATION:
WHICH
IS
BETTER?
.
.
229
22.1.3
DEVELOPING
AN
EFFECTIVE
DISSEMINATION
PLAN
.
224
22.1.7
BARRIERS
TO
IMPLEMENTATION
.
.
229
22.1.4
TRADITIONAL
KNOWLEDGE
22.2
PRACTICAL
APPLICATION
.
.
230
DISSEMINATION
.
225
22.3
CONCLUSION
.
.
231
PARTV
ADVANCED
PRINCIPLES
OF
RESEARCH
COORDINATION
.
.
235
YDO
V.
KLEINLUGTENBELT,
RUDOLF
W.
POOLMAN
23
REGULATORY
TRIALS:
KEY
DIFFERENCES
FROM
STANDARD
TRIALS
.
.
236
DEBORAH
J.
CARR
23.1
INTRODUCTION
.
236
23.3
THE
RESEARCH
COORDINATOR
*
S
23.1.1
WHAT
ARE
CLINICAL
AND
REGULATORY
RESPONSIBILITIES
.
.
242
TRIALS?
.
236
23.4
STANDARD
DEFINITIONS
.
.
242
23.2
HISTORY
OF
REGULATION
AND
23.5
EXPEDITED
REPORTING:
WHEN,
INTERNATIONAL
HARMONIZATION
.
236
WHAT,
WHY,
AND
HOW?
.
.
243
23.2.1
ROLE
OF
THE
REGULATORY
AGENCY
.
237
23.5.1
WHAT
AND
WHY?
.
.
243
23.2.2
STRUCTURE
OF
REGULATORY
TRIALS
.
238
23.5.2
WHEN?
.
.
243
23.2.3
KEY
DIFFERENCES
BETWEEN
STANDARD
CLINICAL
TRIALS
AND
23.5.3
23.5.4
EVENT
TIME
FRAME
.
HOW?
.
.
243
.
243
REGULATORY
TRIALS.
238
23.2.4
GOOD
CLINICAL
PRACTICE
RELEVANT
IN
23.5.5
DOCUMENTATION
.
.
243
REGULATORY
TRIALS
.
239
23.5.6
AUDITS
.
.
243
23.2.5
FOLLOW
A
DETAILED
PROTOCOL
.
240
23.5.7
INVESTIGATOR
QUALIFICATIONS
AND
23.2.6
TRIAL
REGISTRATION
.
240
AGREEMENTS
.
.
244
23.2.7
PROMPT
REPORTING
AND
PUBLIC
23.5.8
CLINICAL
STUDY
REPORT
.
.
244
DISCLOSURE
OF
INTERVENTIONAL
CLINICAL
23.5.9
PRACTICAL
APPLICATION
.
.
244
TRIAL
RESULTS
.
241
23.6
CONCLUSION
.
.
249
23.2.8
SAFETY
REPORTING
.
242
24
HOW
TO
SURVIVE
A
SITE
AUDIT
.
.
251
24.1
INTRODUCTION
.
.
251
24.5
DOCUMENTATION
.
.
253
24.2
THE
DIFFERENCE
BETWEEN
24.6
MEETINGS
AND
INTERVIEWS
WITH
MONITORING
AND
AUDITING
.
.
251
AUDITORS
.
.
254
24.2.1 FIRST
LINE
OF
DEFENSE:
PROCEDURES
.
.
251
24.6.1
INTRODUCTION
OR
START-UP
24.2.2
SECOND
LINE
OF
DEFENSE:
MEETING
.
.
254
MONITORING
.
.
252
24.6.2
AUDIT
INTERVIEWS
.
.
254
24.2.3 THIRD
LINE
OF
DEFENSE:
AUDITING
.
.
252
24.6.3
DAILY
BRIEFINGS
.
.
255
24.3
WHAT
TO
DO
WHEN
YOU
FIND
24.6.4 INFORMAL
CONVERSATIONS
IN
BETWEEN
OUT
YOU
WILL
BE
AUDITED
.
.
253
AUDIT
EVENTS
.
.
255
24.4
CONTENT
OF
THE
STUDY:
THE
BIG
PICTURE
.
.
253
24.6.5
FINAL
AUDIT
MEETING
.
.
255
XII
CONTENTS
24.7
ROLE
OF
THE
PI,
RESEARCH
24.9.1
AUDIT
REPORT
.
.
256
COORDINATOR,
AND
TEAM
.
255
24.9.2
CORRECTIVE
ACTION/PREVENTIVE
24.8
PRACTICAL
ASPECTS:
TRAVEL,
SPACE,
ACTION
PLAN
(CAPA
PLAN)
.
.
256
FOOD
AND
DRINKS
.
256
24.9.3
LIFE
AFTER
THE
AUDIT
.
.
257
24.9
REPORT
AND
CORRECTIVE
ACTION/
PREVENTIVE
ACTION
PLAN
(CAPA
PLAN)
.
256
24.10
PRACTICAL
APPLICATION
.
.
257
25
MONITORING
IN
A
CLINICAL
STUDY:
WHY
AND
HOW?
.
.
258
DAVID
POGORZELSKI
25.1
INTRODUCTION
.
258
25.12
RISK-BASED
MONITORING
.
.
264
25.2
PURPOSE
OF
MONITORING
.
258
25.13
DATA
AND
SAFETY
MONITORING
25.3
RESPONSIBILITIES,
EXTENT,
AND
COMMITTEE
.
.
265
NATURE
OF
MONITORING
.
258
25.14
PRACTICAL
APPLICATION:
ENSURING
25.4
MONITOR
QUALIFICATIONS
.
258
AN
AWESOME
SITE
VISIT
.
.
265
25.5
MONITORING
VISITS
.
259
25.15
SCHEDULING
.
.
265
25.6
SITE
SELECTION
VISIT
.
.
259
25.16
PREPARATION
.
.
265
25.7
SITE
INITIATION
VISIT
.
260
25.17
PREVIOUS
MONITORING
REPORTS.
.
.
265
25.8
ROUTINE
MONITORING
VISITS
.
260
25.18
DURING
THE
VISIT
.
.
266
25.9
CLOSEOUT
VISIT
.
261
25.19
AFTER
THE
VISIT
.
.
266
25.10
MONITORING
REPORTS
.
262
25.20
MANAGING
EXPECTATIONS
.
.
266
25.11
CENTRALIZED
MONITORING
.
262
26
MANAGING
LARGE
STUDIES:
ORGANIZATION
AND
COMMITTEES
.
.
267
STEPHANIE
L
TANNER
26.1
INTRODUCTION
.
267
26.3
ADDITIONAL
STUDY
OVERSIGHT
26.2
STUDY
MANAGEMENT
COMMITTEE
.
,
267
COMMITTEES
.
.
270
26.2.1
STUDY
PRINCIPAL
INVESTIGATOR
.
267
26.3.1
STEERING
COMMITTEE
.
.
271
26.2.2
COINVESTIGATORS
.
268
26.3.2
DATA
SAFETY
MONITORING
26.2.3
STUDY
MANAGER
.
269
COMMITTEE/DATA
SAFETY
MONITORING
BOARDS
.
.
271
26.2.4
DATABASE
MANAGERS
.
269
26.3.3
ADJUDICATION
COMMITTEE
.
.
273
26.2.5
FINANCIAL
ANALYSTS/BUSINESS
ANALYSTS
.
269
26.4
OTHER
STUDY
COMMITTEES
.
.
274
26.2.6
RESEARCH
ASSISTANTS
.
270
26.4.1
WRITING
COMMITTEE/DATA
DISSEMINATION
COMMITTEE
.
AUDIT/MONITORING
COMMITTEE
.
274
26.2.7
STUDY
STATISTICIAN
.
270
26.4.2
.
274
26.2.8
STUDY
MONITORS
.
270
26.5
PRACTICAL
APPLICATION
.
.
274
26.2.9
ADDITIONAL
TEAM
MEMBERS
.
270
26.6
.
275
CONCLUSION
.
27
INTERNATIONAL
RESEARCH:
CHALLENGES
AND
SUCCESSES
.
.
276
CHUAN
SILVIA
LI,
MANDEEP
S.
DHILLON
27.1
INTRODUCTION
.
.
276
27.6
LANGUAGE
CHALLENGES
.
.
278
27.2
STUDY
PLANNING
PHASE
.
.
276
27.7
TIME
ZONE
DIFFERENCE
.
.
278
27.3
ETHICS
APPROVAL
.
.
277
27.8
SHORTAGE
OF
RESEARCH
STAFF
.
.
278
27.4
CONSENT
PROCESS
.
.
277
27.9
DATA
COLLECTION
PROCESS
.
.
278
27.5
MOTIVATING
COINVESTIGATORS
.
.
277
27.10
LOWER
DATA
QUALITY
.
.
278
XIII
CONTENTS
27.11
TIMELINE
DELAY
.
278
27.12
FINANCIAL
CHALLENGES
.
278
27.13
LEGAL
CONSIDERATIONS
.
279
27.14
PRACTICAL
APPLICATION
.
279
27.14.1
LAYING
THE
GROUNDWORK
*
THE
INORMUS
PILOT
STUDY
.
279
27.15
CONCLUSION
.
282
PART
VI
A
COORDINATOR
*
S
TOOLBOX
.
285
VINICIUS
Y.
DE
MORAES,
ASHOK
K.
SHYAM
TOOLBOX
A
.
286
TOOLBOX
B
.
288
TOOLBOX
C
.
290
TOOLBOX
D
.
292
TOOLBOX
E
.
293
TOOLBOX
FL
.
299
TOOLBOX
F2
.
300
TOOLBOX
F3
.
301
TOOLBOX
F4
.
302
TOOLBOX
F5
.
303
TOOLBOX
F6
.
304
TOOLBOX
F7
.
305
TOOLBOX
F8
.
306
TOOLBOX
F9
.
308
TOOLBOX
F10
.
309
TOOLBOX
FL
1
.
310
TOOLBOX
G
.
312
INDEX
.
314
XIV |
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| spelling | The coordination of clinical research a handbook for research coordinators Mohit Bhandari, MD, PhD, FRCSC, Esther M. M. Van Lieshaout, MSc, PhD Stuttgart Thieme [2020] © 2020 xx, 320 Seiten 35 Illustrationen 24.2 cm x 17.5 cm txt rdacontent n rdamedia nc rdacarrier Enthält: 1 Online-Ressource Koordination (DE-588)4032393-6 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Klinisches Experiment (DE-588)4164223-5 s Koordination (DE-588)4032393-6 s DE-604 Bhandari, Mohit (DE-588)136998356 edt Lieshout, Esther M. M. van (DE-588)1204449139 edt Georg Thieme Verlag KG (DE-588)1064287301 pbl X:MVB text/html http://deposit.dnb.de/cgi-bin/dokserv?id=af7ffc6bfe5249dc9dc5028e7649bec5&prov=M&dok_var=1&dok_ext=htm 2019-12-18 Verlag Inhaltstext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=031829894&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | The coordination of clinical research a handbook for research coordinators Koordination (DE-588)4032393-6 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| subject_GND | (DE-588)4032393-6 (DE-588)4164223-5 (DE-588)4143413-4 |
| title | The coordination of clinical research a handbook for research coordinators |
| title_auth | The coordination of clinical research a handbook for research coordinators |
| title_exact_search | The coordination of clinical research a handbook for research coordinators |
| title_full | The coordination of clinical research a handbook for research coordinators Mohit Bhandari, MD, PhD, FRCSC, Esther M. M. Van Lieshaout, MSc, PhD |
| title_fullStr | The coordination of clinical research a handbook for research coordinators Mohit Bhandari, MD, PhD, FRCSC, Esther M. M. Van Lieshaout, MSc, PhD |
| title_full_unstemmed | The coordination of clinical research a handbook for research coordinators Mohit Bhandari, MD, PhD, FRCSC, Esther M. M. Van Lieshaout, MSc, PhD |
| title_short | The coordination of clinical research |
| title_sort | the coordination of clinical research a handbook for research coordinators |
| title_sub | a handbook for research coordinators |
| topic | Koordination (DE-588)4032393-6 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| topic_facet | Koordination Klinisches Experiment Aufsatzsammlung |
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