Cdisc Sdtm Interview Questions and Answers 2019 | Cdisc Sdtm | Wisdom IT Services
Want to become a professional in CDISC Sdtm? Then go through Wisdom jobs to search for your dream job. There are many Cdisc Sdtm jobs available in reputed companies. CDISC is abbreviated for Clinical Data Interchange principles Consortium and it is made keeping in mind to bring big deal of competence in the whole drug development procedure. CDISC brings effectiveness to the entire drug development procedure by enhancing the data quality and speed-up the entire drug development process and to carry out that CDISC developed a sequence of standards, which include Study Data Tabulation Model (SDTM), Operation data Model (ODM), and the Analysis Data Model ADaM). Visit our Cdisc Sdtm job interview questions and answers page for frequently asked questions in the AM job interview.
10) What are the docs do you submit to FDA? Ans: We submit ISS and ISE documents to FDA.
Have you ever had to follow SOPs or programming guidelines? SOP describes the process to assure that standard coding activities, which produce tables, listings and graphs, functions and/or edit checks, are conducted in accordance with industry standards are appropriately documented. It is normally used whenever new programs are required or existing programs required some modification during the set-up, conduct, and/or reporting clinical trial data.44.
13) Tell me about your project group? To whom you would report/contact? Ans: My project group consisting of six members, a project manager, two statisticians, lead programmer and two programmers. I usually report to the lead programmer. If I have any problem regarding the programming I would contact the lead programmer. If I have any doubt in values of variables in raw dataset I would contact the statistician. For example the dataset related to the menopause symptoms in women, if the variable sex having the values like F, M. I would consider it as wrong; in that type of situations I would contact the statistician.
25) Have you created transport files? Ans: Yes, I have created SAS Xport transport files using Proc Copy and data step for the FDA submissions. These are version 5 files. we use the libname engine and the Proc Copy procedure, One dataset in each xport transport format file. For version 5: labels no longer than 40 bytes, variable names 8 bytes, character variables width to 200 bytes. If we violate these constraints your copy procedure may terminate with constraints, because SAS xport format is in compliance with SAS 5 datasets.
Each separate system may also use a different data organization/format. Common data source formats are relational databases and flat files but may include non-relational database structures such as IMS or other data structures such as VSAM or ISAM.
Frequently Asked Clinical SAS Interview Questions
| S.No | SAS Clinical | Oracle Clinical |
| 1 | It is mainly used for statistical analysis | It is mainly used for data management. |
| 2 | It is built on the idea of converting data management to that statistical analysis | It is built on the idea of assisting data management. |
What is the task of the following in the SAS?
FAQ
What is SDTM used for?
What are the Cdisc domains?
What is SDTM programming?
- Domain: A collection of logically related observations with a common, specific topic that are normally collected for all subjects in a clinical investigation. …
- Dataset: A collection of structured data in a single file.
