关于临床试验数据管理的经典书籍！希望大家喜欢！Contents
Part one: Elements of the process
Chapter 1 The data management plan ...........................................................3
What goes into a plan? .................................................................................4
Revising the DMP..........................................................................................5
Using plans with CROs ................................................................................5
Quality assurance and DMPs ......................................................................6
SOPs for DMPs and study files...................................................................6
Using data management plans....................................................................7
Chapter 2 CRF design considerations ............................................................9
Data cleaning issues ....................................................................................10
Data processing issues ................................................................................12
Revisions to the CRF ...................................................................................16
Quality assurance for CRFs........................................................................17
SOPs on CRF design ...................................................................................18
Reuse and refine CRF modules.................................................................18
Chapter 3 Database design considerations .................................................19
Making design decisions ............................................................................19
High-impact fields .......................................................................................20
Tall-skinny versus short-fat .......................................................................30
Using standards ...........................................................................................32
After deciding on a design.........................................................................33
Quality assurance for database design ....................................................33
Standard operating procedures for database design.............................34
Responsibilities in database design ..........................................................34
Chapter 4 Study setup .....................................................................................35
A plan for validation...................................................................................36
Specification and building..........................................................................36
Testing............................................................................................................37
x Contents
Moving to production.................................................................................38
Change control .............................................................................................38
Setup for EDC systems ...............................................................................40
Quality assurance.........................................................................................41
SOPs for study setup...................................................................................41
Setup is programming ................................................................................41
Chapter 5 Entering data...................................................................................43
Transcribing the data ..................................................................................43
How close a match?.....................................................................................45
Dealing with problem data ........................................................................46
Modifying data.............................................................................................48
Quality control through database audits.................................................49
SOPs for data entry .....................................................................................51
Enter quality .................................................................................................51
Chapter 6 Tracking CRF pages and corrections.........................................53
Goals of tracking..........................................................................................53
CRF workflow ..............................................................................................54
Tracking challenges .....................................................................................55
Missing pages reports .................................................................................57
Tracking query forms..................................................................................58
CROs and tracking ......................................................................................59
Quality assurance and quality control .....................................................59
SOPs for tracking .........................................................................................60
Tracking throughout the process ..............................................................60
Chapter 7 Cleaning data..................................................................................61
Identifying discrepancies............................................................................62
Managing discrepancies .............................................................................66
Resolving queries.........................................................................................69
Quality assurance and quality control .....................................................71
SOPs for discrepancy management..........................................................72
Making a difference.....................................................................................73
Chapter 8 Managing laboratory data............................................................75
Storing lab data ............................................................................................76
Storing units..................................................................................................79
Ranges and normal ranges.........................................................................80
Checking result values................................................................................81
Using central labs ........................................................................................82
Using specialty labs.....................................................................................82
Loading lab data ..........................................................................................84
Quality assurance.........................................................................................86
SOPs for processing lab data .....................................................................86
Taking lab data seriously ...........................................................................87
Contents xi
Chapter 9 Collecting adverse event data .....................................................89
Collecting AEs ..............................................................................................89
Coding AE terms .........................................................................................93
Reconciling SAEs .........................................................................................94
Quality assurance and quality control .....................................................96
SOPs for AE data .........................................................................................96
Impact on data management .....................................................................97
Chapter 10 Creating reports and transferring data ...................................99
Specifying the contents ...............................................................................99
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