Transcript What is PheedIt? - Att driva kvalitetsregister

Data Management in
Clinical Trials
Monitoring
Protocol
E-CRF design /
P-CRF
Data entry
Data
Management
Plan
Data validation
Clinical coding
Data import
Database
Closure
Documents
DATABASE
CLOSURE
Database lock
Final
report
Database
export
Draft
report
Tables & listings /
graphs
SAS programming
finalising analysis
database
Data Management Plan, DMP
The DMP is a description of data
management activities for capturing
and validating data during a study.
Included in DMP
1.
List of abbreviations
2.
Definitions/Clarifications
3.
Introduction
4.
Study information/Description
5.
Data Management System (CDMS)
6.
Data management procedures
7.
Data entry procedures
8.
Data query handling
9.
Data validation procedures
10.
Coding procedures
11.
Database closure
12.
Export of data
13.
Import of data
14.
Appendix
CRF
•
CDISC/CDASH standard or sponsors standard
(should be stated in the contract).
•
Footnote on all pages containing: version, date and
initials
•
Header on all pages containing: study number, site
number, subject number, subject initials/ID, visit
number.
•
Follow ICH GCP guidelines.
•
Follow GCDMP guidelines.
P-CRF (paper CRF)
P-CRF
•
Reviewed by internal study team (PM, DM, STAT,
monitor) before sent to sponsor
•
Reviewed by clinical team (sponsor, investigator,
study nurse)
•
Approved by sponsor (if required by sponsor), PM,
DM and STAT (date and signature)
•
Remember CRF Receipt Log when using P-CRF
E-CRF (Electronic CRF)
E-CRF
•
Created in CDMS
•
Reviewed by internal study team (PM, DM, STAT,
monitor)
•
Reviewed by clinical team (sponsor, investigator,
study nurse), review = access to a test database
•
Approved by sponsor (if required by sponsor), PM,
DM and STAT (date and signature)
DATA ENTRY (DE)
•
At site (E-CRF)
•
Internal (P-CRF)
•
Single or Double DE
•
Data Entry Log
•
Data Entry Problem Sheet (DEPS)
•
Data Handling Instructions
• E.g. Enter date as YYYY-MM-DD
• E.g. Enter Not Applicable as NA
QUERY HANDLING
P-CRF
• Data entry errors documented in DEPS (Data Entry
Problem Sheet). DM investigates whether these errors
should be queries/DCF.
• CDM can also produce queries from logical checks.
• During QC.
QUERY HANDLING
E-CRF
• Query handling in the system according to the E-CRF
• Queries can be generated by monitor or DM within (or
outside) the system.
• Logical checks can be included in the CDMS or be
created outside the system.
QUERY HANDLING
All CDM queries are logged (study number, site, subject
number, date sent, name of query creator, date
received, date when changed in DB in paper CRF, name
of person who changed query in DB)
CLINICAL CODING
Clinical Coding – the translation of medical terminology
into a standardized coded format that is recognized
nationally and internationally.
CLINICAL CODING
•
Study specific coding information in the DMP, e.g.
what to code, dictionaries, when coding is to be done.
•
Coding done by assigned coder.
•
Reviewed and confirmed by medical reviewer.
•
Final coding approved (signed and dated) by
sponsor.
•
Final coding dictionaries version should be
documentet
•
If all been coded or something is uncoded
medication/AE/Med hist documented in the DHR
(Data Handling Report)
DATA IMPORT/EXPORT
•
According to specification in DMP
E.g. ECG, biomarkers
•
Validation of imported/exported data
Transfer specification
DATABASE CLOSURE
•
When all queries are solved:
•
Quality Control
•
•
•
•
•
•
Proof Reading (only P-CRF)
Logical Checks
Approved Clinical Coding
Approved Statistical Analysis Plan (SAP)
All issues are documented
Approved and signed Database Closure Document