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Tag Archives: clinical data management
Top 3 Posts at (EDC Developer)
Fist, I would like to thank everyone who has read articles posted at {EDC} Developer. Especially, my colegas and friends from India. The highest reading and hits have come from people living in India.
New to the industry? Want to get in as clinical data manager or clinical programmer? Looking for a particular topic or an answer to a question? check the contact me section.
Here are the top most searched articles this past few months:
1- Data Management: Queries in Clinical Trials
2- How to document the testing done on the edit checks?
3- Why use JReview for your Clinical Trials?
Others most read articles:
Role of Project Management and the Project Manager in Clinical Data Management
4 Programming Languages You Should Learn Right Now (eClinical Speaking)
Data Management Plan in Clinical Trials
For the search term used to find {EDC} Developer:
1-types of edit checks in clinical data management
2-Rave programming
3- pharmaceutical terminology list
4-seeking rave training (better source is mdsol.com)
5- edc programmer
6-central design tips and tricks
Thank you for reading!
Data Management Plan – Coding and Reconciliation
All Adverse Events and Previous/Concomitant Medication should be coded and/or approved prior and during the trial.
Before adverse event terms can be reported or analyzed, they must be grouped based on their similarities. For example, headache, mild headache and acute head should all be counted as the same kind of event. This is done by matching (or coding) the reported adverse events against a large codelist of adverse events which is also known as dictionary or thesaurus.
Test cases and other documentation associated with the testing of auto-coding should be produced/documented. This documentation is not part of the plan. It is a product of the design process and should be filed separately in the TMF system.
In the DMP. you should document the variables and the dictionary to be used.
For Concomitant Medications, WHO drug reference list is used. Also document the version used and if applicable, the final version of the who drug (for trials running over 6 months).
For Adverse event, MedDRA dictionary is the choice of coding method. Document the version used.
Serious Adverse Event (SAE) Reconciliation:
Indicate SAE Reconciling Approach to be used to compare SAE database (e.g. Argus) to the Clinical study| database (e.g. EDC):
- Indicate tools to be used
- Location of SAE data
- Planned timing
- Planned frequency of SAE Reconciliation activities
What to look for during reconciliation:
- There are matched cases but minor differences such as onset date
- Case found in the CDMS but not in the SAE system
- Case found in the SAE system but not in the CDM system
Methods for Reconciliation:
For electronic-automatic reconciliation between systems, there are some challenges you need to identify first such as which type of data is to be reconciled and then which fields to compare. Best practice is to reconciled those considered serious according to regulatory definitions.
For manual reconciliation, reports such as SAS listings extracted from both systems with study information, subject or investigator and other key data can be used to perform manual review. A manual comparison of the events can then assure that they are both complete and comparable.
No matter which method you used for reconciliation, each type of data (eg, AE, MedHist, Conmed) should document which glossaries and version were used.
When data from the clinical trial database is entered into a drug safety database for coding, the data between the two systems should be reconciled to verify the data in both systems are
identical. The processes and frequency of reconciliation should be specified.
Source:
DIA -A Model Data Management Plan StandardOperating Procedure: Results From
the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan
-FAIR ;USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.
Data Management Plan – Study Specific Documents
Data Management personnel are responsible for creating, collecting, maintaining and/or retaining all essential study documents when contracted by the sponsor (e.g. biotech company, big pharma client).
It is important to keep electronic and paper records or hard-copies and specify retention records of these essential documents:
- Final version including amendments of the clinical protocol
- Final version of the CRF/eCRFs
- Final version of the completion guidelines
- All final approvals and written authorization (e.g. emails or note to files).
-FAIR ;USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.
Data Management Plan – Protocol Summary
This usually describes the management plan for the data collected during the project. It is a brief description or synopsis of the protocol.
The protocol, in terms of a clinical research study, is the plan, or blueprint, that
describes the study’s objectives, methodology, statistical considerations, and the organization of the study. [CDISC.org Oct. 2012]
What to look for when reading a protocol?
- Review of T&E – Time and Event Schedule or Visit Schedule.
- Assessments e.g. ECGs, PE (physical exams), MH-MedHix or Medical HIstory, labs and more.
- Critical data variables for analysis. e.g. efficacy and safety data
proc print data= work.demog;
where patient in(“&pid”) and page=’3′;
var patient SBJINT page
dob sex bmi weight height;
title ‘Page 3 – Demog’;
run;
-FAIR ;USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.
Case Study 1: Stand Alone Satellite Office Solution
Integrated Into Sponsor’s Clinical Data Management (CDM) Environment
The Scenario:
The Sponsor was in need of a data management team to function in an integrated manner as an extension of the Sponsor’s CDM team. Based on geographic and offices constraints, coupled with the large volume of work, hiring individual contract resources on-site was not an option.
RA eClinica Solution:
- RA eClinica Data Management Operations collaborated with Sponsor to develop CDM metrics, collaboration model and workflow, enabling the team to work across 3+ protocols
- RA eClinica provided a full solution of 5+ CDM resources, project management, dedicated secure facilities integrating into Sponsor’s eClinical and CDMS databases.
Ra eClinica Results:
- Develop of a long-term, efficient and cost-effective CDM solution.
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
CDISC Training and Support
CDISC Training
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
Clintrial Training
Clintrial Training
Learn Clintrial or for Clinical trial support contact us.
Clirinx EDC Demo
Quick overview of Clirinx EDC
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation of EDC systems, please contact us
Castor EDC Demo
Castor EDC Training and Support
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
