Clinical Data Management(presentation By Sarma)
This document was uploaded by user and they confirmed that they have the permission to share it. If you are author or own the copyright of this book, please report to us by using this DMCA report form. Report DMCA
Overview
Download & View Clinical Data Management(presentation By Sarma) as PDF for free.
More details
- Words: 1,042
- Pages: 30
Clinical Data Management by T V S Sarma for more information: [email protected]
What is Clinical Data management ?
Clinical Data Management is the process of ensuring that the data colleted during a clinical trial is … Accurate : perfect conformity to fact or truth ; strictly correct Complete : Having every necessary or normal part Logical : Legitimate Consistent : The same, throughout in structure or composition
Page 2
Goal of CDM
To provide complete quality data ‘timely.’
Quality data is defined as ‘data that sufficiently support conclusions and interpretations equivalent to those derived from error free data.’ Achieved by ensuring that ...
Page 3
…goal of CDM
The collected data is complete and accurate so that the results are correct.
The trial database is complete and accurate, and a true representation of what took place in the trial
The trial database is sufficiently clean to support the statistical analysis, and its subsequent presentation and interpretation
Page 4
Why CDM ? What ICH GCP Guidelines say
All clinical research data should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification (GCP 2.10) Quality assurance and quality control systems with written standard operating procedures should be implemented and maintained to ensure that research are conducted and data are generated, documented and recorded, and reported in compliance with the protocol, GCP and applicable regulatory requirements. (GCP 5.1.1)
Page 5
…what ICH GCP Guidelines say
Systems with procedures that assure the quality of every aspect of the research should be implemented (GCP 2.13) If data are transformed during processing, it should always be possible to compare the original data and observations with the processed data (ICH GCP 5.5.4)
Page 6
Why CDM ? Some technology challenges
Mail us at: [email protected] To get the missing content absolutely FREE
Page 7
Why CDM ? Compliance
Compliance with 21 CFR part 11: security, audit trail, version control Validation - accuracy, reliability, consistent intended performance and the means to discern invalid or altered records Restriction of system access to only authorized individuals
Page 8
…compliance
Secure, computer-generated, time-stamped audit trails to record operator entries and action to create, modify and delete electronic records – retained for required period and available for agency review and copying Operational system checks to enforce permitted sequencing of steps and events as appropriate
Page 9
Relevant Standards CDISC
Mail us at: [email protected] To get the missing content absolutely FREE
Page 10
CDMS
Clinical Data Management System … Paraphrasing, we can define it as a system for management of clinical data, where … System means both the hardware and software Clinical Data, refers to any textual, graphical, audio, pictorial data acquired during a clinical trial
Page 11
Potential for problems
Mail us at: [email protected] To get the missing content absolutely FREE
Page 12
Activities involved in Data Management
1. 2. 3. 4. 5. 6. 7.
Scanning the source documents and tagging the source data with electronic format 21 CFR Part 11 requirement analysis Preparation of Data Management Plan Selection of Digitization tool Creation of data entry screens Creation of edit checks and Data Quality Checks Data security implementation
Page 13
…activities involved in Data Management
Mail us at: [email protected] To get the missing content absolutely FREE
Page 14
The ‘How’ of Data Management The DMP (Data Management Plan)
What a DMP does
Specifies . . . What is the work to be performed? Who is responsible for the work? Which SOPs or guidelines will apply? What documentation or output will be collected or produced?
Page 15
DMP continued…
Mail us at: [email protected] To get the missing content absolutely FREE
Page 16
When does the DM Process start
Immediately after the Protocol has been finalized and approved This means that a part of the DM team needs to be involved in CRF design Common mistake : Design CRF without DM process in mind
Page 17
CRF Scanning
To ensure compliance with 21 CFR Part 11 CRFs are scanned soon after receipt in the CRF Tracking system and archived electronically into an image Database.
Page 18
CRF Scanning
Page 19
Database Design
Database is Designed and the relevant entities like Database Tables, Procedures, Validation programs are created in the Selected Software like Oracle Data entry screens are created such that they closely resemble the Paper CRF.
Page 20
Data Entry and Verification
Mail us at: [email protected] To get the missing content absolutely FREE
Page 21
Data entry and verification
Mail us at: [email protected] To get the missing content absolutely FREE
Page 22
Data Validation/Edit Check
Consists of computer Checks on the Data to ensure the Validity and Accuracy of Data Validate Data against predetermined Specifications
Page 23
Types of Checks?
Mail us at: [email protected] To get the missing content absolutely FREE
Page 24
Data Analytics
Preparation of Statistical Analysis Plan (SAP) Creation of Data Marts Creation of Tables and Listings Performing Statistical Analysis using SAS
Page 25
…Data Analytics
Analysis of Pharmacokinetic, Epidemiological and Clinical Trial Data Clinical Report generation Creation of Domain Sets as per CDISC SDTM Regulatory submission using SAS
Page 26
Database Closure
Points to be considered in database closure preparation include the following: 1. All data have been received and processed. 2. All queries have been resolved 3. External data (e.g. electronic laboratory data) are reconciled with the study database and are complete 4. If a separate, serious adverse event database exists, it is reconciled with the main study database
Page 27
Database Closure…
5.
The coding list has been reviewed for completeness and consistency.
6.
Final review of logic and consistency check output has taken place.
7.
Final review for obvious anomalies has taken place.
8.
Quality audit of the data and documentation of the error rate have occurred.
9.
All documentation is updated and stored where required by Standard Operation Procedures.
Page 28
CDMS Solutions
Data Analytics: SAS EDC: Oracle Clinical, Phase Forward Document management services: Documentum, Adobe
Page 29
Mail us at: [email protected] To get the missing content absolutely FREE
What is Clinical Data management ?
Clinical Data Management is the process of ensuring that the data colleted during a clinical trial is … Accurate : perfect conformity to fact or truth ; strictly correct Complete : Having every necessary or normal part Logical : Legitimate Consistent : The same, throughout in structure or composition
Page 2
Goal of CDM
To provide complete quality data ‘timely.’
Quality data is defined as ‘data that sufficiently support conclusions and interpretations equivalent to those derived from error free data.’ Achieved by ensuring that ...
Page 3
…goal of CDM
The collected data is complete and accurate so that the results are correct.
The trial database is complete and accurate, and a true representation of what took place in the trial
The trial database is sufficiently clean to support the statistical analysis, and its subsequent presentation and interpretation
Page 4
Why CDM ? What ICH GCP Guidelines say
All clinical research data should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification (GCP 2.10) Quality assurance and quality control systems with written standard operating procedures should be implemented and maintained to ensure that research are conducted and data are generated, documented and recorded, and reported in compliance with the protocol, GCP and applicable regulatory requirements. (GCP 5.1.1)
Page 5
…what ICH GCP Guidelines say
Systems with procedures that assure the quality of every aspect of the research should be implemented (GCP 2.13) If data are transformed during processing, it should always be possible to compare the original data and observations with the processed data (ICH GCP 5.5.4)
Page 6
Why CDM ? Some technology challenges
Mail us at: [email protected] To get the missing content absolutely FREE
Page 7
Why CDM ? Compliance
Compliance with 21 CFR part 11: security, audit trail, version control Validation - accuracy, reliability, consistent intended performance and the means to discern invalid or altered records Restriction of system access to only authorized individuals
Page 8
…compliance
Secure, computer-generated, time-stamped audit trails to record operator entries and action to create, modify and delete electronic records – retained for required period and available for agency review and copying Operational system checks to enforce permitted sequencing of steps and events as appropriate
Page 9
Relevant Standards CDISC
Mail us at: [email protected] To get the missing content absolutely FREE
Page 10
CDMS
Clinical Data Management System … Paraphrasing, we can define it as a system for management of clinical data, where … System means both the hardware and software Clinical Data, refers to any textual, graphical, audio, pictorial data acquired during a clinical trial
Page 11
Potential for problems
Mail us at: [email protected] To get the missing content absolutely FREE
Page 12
Activities involved in Data Management
1. 2. 3. 4. 5. 6. 7.
Scanning the source documents and tagging the source data with electronic format 21 CFR Part 11 requirement analysis Preparation of Data Management Plan Selection of Digitization tool Creation of data entry screens Creation of edit checks and Data Quality Checks Data security implementation
Page 13
…activities involved in Data Management
Mail us at: [email protected] To get the missing content absolutely FREE
Page 14
The ‘How’ of Data Management The DMP (Data Management Plan)
What a DMP does
Specifies . . . What is the work to be performed? Who is responsible for the work? Which SOPs or guidelines will apply? What documentation or output will be collected or produced?
Page 15
DMP continued…
Mail us at: [email protected] To get the missing content absolutely FREE
Page 16
When does the DM Process start
Immediately after the Protocol has been finalized and approved This means that a part of the DM team needs to be involved in CRF design Common mistake : Design CRF without DM process in mind
Page 17
CRF Scanning
To ensure compliance with 21 CFR Part 11 CRFs are scanned soon after receipt in the CRF Tracking system and archived electronically into an image Database.
Page 18
CRF Scanning
Page 19
Database Design
Database is Designed and the relevant entities like Database Tables, Procedures, Validation programs are created in the Selected Software like Oracle Data entry screens are created such that they closely resemble the Paper CRF.
Page 20
Data Entry and Verification
Mail us at: [email protected] To get the missing content absolutely FREE
Page 21
Data entry and verification
Mail us at: [email protected] To get the missing content absolutely FREE
Page 22
Data Validation/Edit Check
Consists of computer Checks on the Data to ensure the Validity and Accuracy of Data Validate Data against predetermined Specifications
Page 23
Types of Checks?
Mail us at: [email protected] To get the missing content absolutely FREE
Page 24
Data Analytics
Preparation of Statistical Analysis Plan (SAP) Creation of Data Marts Creation of Tables and Listings Performing Statistical Analysis using SAS
Page 25
…Data Analytics
Analysis of Pharmacokinetic, Epidemiological and Clinical Trial Data Clinical Report generation Creation of Domain Sets as per CDISC SDTM Regulatory submission using SAS
Page 26
Database Closure
Points to be considered in database closure preparation include the following: 1. All data have been received and processed. 2. All queries have been resolved 3. External data (e.g. electronic laboratory data) are reconciled with the study database and are complete 4. If a separate, serious adverse event database exists, it is reconciled with the main study database
Page 27
Database Closure…
5.
The coding list has been reviewed for completeness and consistency.
6.
Final review of logic and consistency check output has taken place.
7.
Final review for obvious anomalies has taken place.
8.
Quality audit of the data and documentation of the error rate have occurred.
9.
All documentation is updated and stored where required by Standard Operation Procedures.
Page 28
CDMS Solutions
Data Analytics: SAS EDC: Oracle Clinical, Phase Forward Document management services: Documentum, Adobe
Page 29
Mail us at: [email protected] To get the missing content absolutely FREE
Related Documents
Clinical Data Management(presentation By Sarma)
December 2019 22
Clinical Trial Safety Data Management (presentation By Tvs Sarma)
December 2019 12
Sarma
April 2020 5
Sarma
October 2019 16
Senthilkumar Clinical Data
June 2020 2
Clinical Data Entry
July 2020 7More Documents from "gaurav gupta"
Clinical Trial Safety Data Management (presentation By Tvs Sarma)
December 2019 12
Clinical Data Management(presentation By Sarma)
December 2019 22
Osteomyelitis.docx
April 2020 4
03. Tinjauan Pustaka.docx
April 2020 5
Daftar Pustaka.docx
April 2020 9