Clik here to view.
Professional Timeline – Clinical Programmer
Professional Timeline CVFiled under: 21CRF 11, Advanced SAS, Base, Best Practices, Checklists, Clintrial, Cognos, Data Management, Data Mapping, Data Standards, Data Validation, DMP, eClinical, EDC,...
View ArticleClik here to view.
Central Designer: Constants and Their Role in Query Messages
What are Constants? Constants are that item whose value remains same during the execution of the program from the beginning till the end of a program Pros: Reusable Integer range checks The value of an...
View ArticleClik here to view.
How to write query texts – 6 template sentences
How to write queries unambiguously expressing what is asked for? Using short, polite sentences? Objectively explaining the underlying inconsistency? First …Continue reading →
View ArticleClik here to view.
CDISC/CDASH Standards at your Fingertips
A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can …Continue reading →
View ArticleClik here to view.
Complexity and effectiveness of edit checks
ABSTRACT Much effort goes into the specification, development, testing and verification of programmatic edit checks to ensure that the error …Continue reading →
View ArticleClik here to view.
How to document the testing done on the edit checks?
If you have not documented, you have not done it.
View ArticleClik here to view.
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...
View ArticleClik here to view.
Data Management Plan – Database Archive
Indicate how you intend to archive and share your data and why you have chosen that particular option. The DMP should outline specific information regarding the organization’s procedures for archiving...
View ArticleClik here to view.
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)....
View ArticleClik here to view.
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...
View ArticleFreelancer / Consultant / EDC Developer / Clinical Programmer
* Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC) * Creation of electronic case report forms (eCRFs) * Validation of programs, edit checks * Write validation test scripts...
View ArticleIs this the worst disaster in Clinical Research (Drug)?
In the 1950s, thalidomide cut a wide swath of destruction across the world, leaving behind thousands of deformed infants, but that was only the beginning of the story. Thalidomide – known as Contergan...
View Article
