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E-raamat: Writing and Managing SOPs for GCP

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(Clinical Development Operations Excellence, California, USA)
  • Formaat: EPUB+DRM
  • Ilmumisaeg: 29-Jul-2015
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781040071007
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  • Formaat: EPUB+DRM
  • Ilmumisaeg: 29-Jul-2015
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781040071007
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Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user’s point of view to keep topics focused on the practical aspects of SOPs and SOP management.

The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

Arvustused

"Writing and Managing SOPs for GCP miraculously transforms the boring floss of standard operating procedures into the interesting gold ofSOPs. A reader of this book will find it is hard to imagine managing SOPs without having read the book." Norman M. Goldfarb, in Journal of Clinical Research Best Practices, Vol. 12, No. 2, February 2016

Preface xiii
Acknowledgments xv
About the author xvii
Section I: Founding principles
Chapter 1 Introduction to SOPs
3(6)
What is an SOP?
3(1)
Why do we have SOPs?
4(2)
GCP requires SOPs
4(1)
The organization needs them
5(1)
Why do we follow SOPs?
6(1)
Beyond SOPs
7(1)
Say what we do, do what we say
7(2)
Chapter 2 Document hierarchies
9(16)
Controlled documents and managed documents
9(2)
Overview of the hierarchy
11(2)
More about controlled document types
13(4)
SOP of SOPs
14(1)
SOPs
14(1)
Forms and templates
15(1)
Work instructions and manuals
16(1)
More about managed document types
17(5)
Department-managed documents
18(1)
Training materials and curricula
19(1)
Data standards
20(1)
TMF reference models
21(1)
Process flow diagrams
21(1)
Other document types
22(1)
Where are the policies?
22(1)
Where are guidance documents?
23(1)
Hard-to-classify documents
23(1)
SOP of SOPs
24(1)
Chapter 3 When to have an SOP
25(6)
Does it belong in an SOP?
25(3)
Is it required by GCP?
26(1)
Does it support other regulations?
26(1)
Is it a business need?
27(1)
Benefiting both compliance and business
28(1)
When an SOP is not needed
28(2)
Other ways to introduce consistency
30(1)
SOP of SOPs
30(1)
Chapter 4 What the SOP should say
31(8)
Who, what, when, and where
31(3)
Who and what
31(2)
When and where
33(1)
How and the level of detail
34(1)
Cover one topic or many topics?
35(1)
Too many or too few SOPs
36(1)
SOP of SOPs
37(2)
Chapter 5 Where to put the output
39(10)
What is a trial master file?
39(2)
Contents of a TMF
41(2)
Overview of the DIA TMF Reference Model
41(1)
Company TMF reference models
42(1)
Paper TMFs and electronic TMFs (eTMFs)
42(1)
The TMF connection to SOPs
43(1)
Not all documents belong in the TMF
44(2)
SOP of SOPs
46(3)
Section II: Writing, reviewing, approving, and posting
Chapter 6 Who writes SOPs?
49(4)
Which department provides the author?
49(1)
Selecting an author
50(1)
Clinical Development's Controlled Document group
51(1)
SOP of SOPs
52(1)
Chapter 7 Document a stable process
53(8)
SOPs should not be theoretical
53(1)
Testing a procedure
54(4)
Draft and vet the process
55(1)
Assess the need for deviations
56(1)
Select studies
57(1)
Document the process used
57(1)
When you cannot pilot
58(1)
SOP of SOPs
59(2)
Chapter 8 Mapping a new process
61(10)
Assemble a team
61(1)
Review regulatory requirements
62(1)
List steps or actions in the right order
62(2)
Who is responsible? Who is involved?
64(3)
Identify inputs and outputs
67(1)
Be aware of sequence and prerequisites
67(1)
Translate the process into an SOP
68(1)
Stay aligned with any approved process maps
69(1)
SOP of SOPs
70(1)
Chapter 9 The SOP template
71(20)
Document header
71(2)
Title
71(1)
Document identifier
72(1)
Effective date
72(1)
Version number
73(1)
Purpose and scope
73(4)
Purpose
74(1)
Scope
74(3)
Definitions and background
77(2)
Responsibility
79(1)
Procedure
80(5)
Outline format
81(1)
Table format
81(3)
Roles that cannot appear in procedures
84(1)
Document disposition
85(1)
References
86(2)
Appendices
88(1)
Revision history
89(1)
Other considerations
89(1)
Formatting
89(1)
Template updates
90(1)
SOP of SOPs
90(1)
Chapter 10 SOP review and approval
91(14)
Concentric rings of review
91(6)
Expert review
92(1)
Function or department review
92(2)
Cross-functional review
94(1)
Compliance review
95(1)
Approver review
96(1)
Controlled Document group review
96(1)
Best practices for review
97(4)
Preparing documents for review
97(1)
Sending out for review
98(1)
Tracking reviews and reviewers
99(1)
Adjudicating feedback
99(2)
Approval
101(1)
How long does this take?
102(1)
Reviewing documents from other departments
103(1)
SOP of SOPs
104(1)
Chapter 11 Posting: Setting up for success
105(12)
Is it really ready to post?
105(1)
Communication plans
106(3)
Preparation
106(1)
Communication plan options
107(2)
SOP release cut-over rules
109(3)
Why do we need rules?
110(2)
Implementation memos
112(1)
Posting SOPs
112(1)
SOP of SOPs
113(4)
Section III: Maintaining SOPs: Maintaining compliance
Chapter 12 Deviations from controlled procedures
117(10)
Retrospective deviations
117(2)
Prospective deviations
119(2)
Documenting deviations
121(2)
Deviations from supporting documents
123(1)
Is it really a deviation?
123(2)
SOP of SOPs
125(2)
Chapter 13 Active SOP maintenance
127(16)
The environment changes
127(4)
Regulatory thinking changes
127(2)
Systems and software updates
129(1)
Procedures drift and improve
129(1)
Organizations reorganize
130(1)
Documents change
131(3)
Updating templates and forms
131(1)
Managing cross-references
132(2)
Initiating an update
134(3)
Change requests
134(1)
Major, minor, and administrative changes
135(2)
Keep cycle times short
137(1)
Regular SOP review
137(2)
Current practice
138(1)
Recommended practice
138(1)
SOP of SOPs
139(4)
Section IV: Helping staff follow SOPs
Chapter 14 Finding SOPs
143(6)
Controlled document identifiers
143(2)
Internal web pages
145(1)
Indexes
146(1)
SOP of SOPs
147(2)
Chapter 15 Training on SOPs
149(12)
Options for training
149(4)
Read-and-acknowledge
149(1)
Quizzes as a form of training
150(2)
Just-in-time training
152(1)
Who has to train on which SOPs?
153(5)
Determining training assignments
154(1)
Developing training curricula
154(1)
Assigning curricula to staff
155(1)
Maintaining curricula
156(1)
Training contract staff
157(1)
Training periods
158(1)
Delta training and minor releases
159(1)
SOP of SOPs
159(2)
Chapter 16 Department-managed documents
161(12)
Founding principles
161(2)
When to have a department-managed document
161(1)
What to say in the document
162(1)
Where to put the output
163(1)
Writing, reviewing, approving, and posting
163(4)
Writing and formatting
163(1)
Review, approval, and posting
164(3)
Maintaining compliance
167(1)
Deviations and active maintenance
167(1)
Helping staff use department-managed documents
168(2)
Finding the document
168(1)
Training
169(1)
The document on department-managed documents
170(3)
Section V: Additional topics
Chapter 17 Where to start
173(6)
When the company is virtual
173(1)
Small companies taking on activities
174(2)
What if the SOP is not ready?
175(1)
Which SOPs are used by whom?
176(1)
Do not post untried procedures
176(1)
As the company continues to grow
176(3)
Chapter 18 SOPs during mergers and acquisitions
179(6)
At first
179(1)
The transition period
180(1)
Later
181(1)
Trial master files
182(1)
SOP on acquisitions and mergers?
183(2)
Chapter 19 Controlled glossaries
185(6)
Starting the glossary
185(1)
Role names in the glossary
186(1)
Maintaining the glossary
187(2)
Using glossaries
189(2)
Appendix 1: Example SOP template 191(4)
Appendix 2: Example SOP of SOPs 195(8)
Index 203
Susanne Prokscha is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. She has been involved in clinical data management (CDM) processes and technologies since the mid-1980s. Ms. Prokscha has worked both as a consultant and directly for large and small companies, gaining experience with a wide range of studies and a variety of clinical data management systems. Her interest in advancing the field of CDM and helping emerging CDM groups led her to write Practical Guide to Clinical Data Management. She currently focuses on process development, SOP writing, document management, and training for CDM and Biometrics groups.
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