This blog is writing for 0-1 years of experienced individuals. Fresher’s and less experienced individuals should focus on basics of clinical research and clinical data management. Interviewers does not expect that freshers should know each and every thing about clinical data management. it is always expected that freshers should have a strong knowledge about basics of clinical research and clinical data management.
You can refer this blog to learn about basic of clinical research:
Please refer the below questions while preparing for CDM Job interviews. The Short answers are provided for each questions and links are provided if you want to explore it further.
Table of Contents
What is eDC system?
It is a abbreviation of electronic data capture and it is system/tool which is used to capture clinical trial data in electronic forms.
What are the different eDC systems?
There are many eDC system in the market such as Inform, RAVE, OC-RDC etc.
What do you understand by CRF?
As per ICH E6 (R2),
“A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject”
In simple terms, we can say that it is the form (electronic/paper) which is used to capture the clinical data/information of patients as per the clinical trial protocol. It is a abbreviation of case report form. You can read in details here:
Basics of case report form
What are variables and fields:
Variable are the questions or data points present in the case report forms (CRF).
For example Patient age , country in demographics CRF are called variables. We are asking (question) about patient age and his country in the case report form, hence they are variable.
Fields are the places where site personals enter the data. for example in demography CRF, site has to enter patient age so adjacent to variable-age, there would be a blank space, where site can enter age.
If I need to give a real life example, then I would given an example of college admission form where your name and surnames questions are variables and that blank space where you write your name and surname are fields.
What is protocol?
It is clinical trial document which tells how to perform the trial, its purpose, drug being tested, method, statistical criteria, structure/design of the clinical trial, and visit schedules. It also focuses on wellbeing of participants and validity of clinical trial data.
Please note this is must know document for any fresher and experienced professionals.
Parts of a clinical trial protocol and Clinical Data Management (CDM) prospective to review
Clinical Trial Protocol
What is visit in clinical trial?
As per the protocol, participants have to come to site/hospital to take the drug and/or for assessments such as Lab, x ray etc, this is called as visit. It is properly defined in the visit schedule section of the protocol.
What do you know about CRC?
CRC or clinical research coordinators are the site personals who enters the clinical trial data in eDC and perform many activities on behalf of Principle investigator. They assist Principle investigator in many site activities as per protocol. Please note that ultimate responsibility goes to PI for performing the study at site.
Beginner’s Guide to Clinical Research Coordinator
What do you know about Auto queries and edit checks?
Whenever there is a discrepancy in the data entered in eCRF, a query (question) is fired by the eDC system asking more about data discrepancy. This is called auto query.
These auto queries are written by programmer on the input from data management or other line function such as safety etc. The programs firing auto queries are called edit checks.
Auto queries helps DM to know the discrepancy in the database. In general auto queries are directed towards site and site personals (CRC and PI) has to check auto queries and correct the data and/or reply to the auto queries. Based on corrected data and replies on auto queries, DM or other line function can close it or re-query it. Kindly refer the below link for details:
https://lifepronow.com/2020/07/11/free-course-on-clinical-data-management/
What is CDISC?
It is a abbreviation of Clinical Data Interchange Standards Consortium. It is non for profit organization. It develops the standard for data collection and reporting.
Please read more about SDTM and ADAM here.
ttps://www.cdisc.org/
What is serious adverse event?
As per FDA “An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:”
It is considered serious if it results in death, life threatening, Hospitalization (initial or prolonged), disability or permanent damage and congenital anomaly/birth defect.”
https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
What do you understand by clinical data management?.
Clinical data management deals with clinical trial data and is responsible for data collection, data cleaning, maintaining its integrity, drafting of various clinical trial documents, collaboration across various line function such as safety, medical, clinical, programming etc and final submission to statistical team for its analysis
- What are various Phases of clinical data management?
Clinical data management activities can be divided into three parts:
Set up: In this activity, DM in collaboration with programming and other team, builds the CRFs into eDC as per protocol. DM has to perform testing of eDC to know if it functions as intended or not and draft many documents. Handling of third party data (external data) is also finalised.
Conduct Phase: Once data base (eDC) is ready, site start entering the clinical data and DM has to review the data and raise queries if he/she observes any discrepancies. Third party data and AE reconciliation is done here
Close out: In this phase, the clinical data is finally cleaned and data base is locked. All efforts are done to ensure that data is clean for submission to stats.
What is source data verification (SDV)?
site captures the clinical trial data on patient diaries or similar documents and receive various lab reports on paper or different electronic format. All this clinical data needs to be transcribed into eDC by CRC and PI. The initial documents (patient diaries, lab reports) are called source documents. Clinical research associate (CRA) verifies the information of eDC to check whether information entered on eDC is same as captured on source document or not. This process is called SDV.
Clinical Research Associate: Role, Responsibilities, Skills, and Salary
More experienced individuals can explore the below topics as well.
- Important data points in Protocol for CRFs Creation (CDM Prospective):
- When to Start and Stop collecting Adverse Events
- Parts of a clinical trial protocol and Clinical Data Management (CDM) prospective to review
- ECOG Performance Status
What is the difference between the Central lab and local lab in clinical research?
How to resolve reference ranges issue in RAVE eDC- CRA, CRC and DM prospective.
What is Blinding in Clinical Trial? - What is “Expanded access”?
