Clinical Data Management Interview question Part II.

The guide emphasizes the importance of understanding the fundamental principles of CDM and provides practical examples and scenarios to help you demonstrate your expertise and problem-solving skills. It also offers guidance on how to showcase your knowledge of industry regulations and guidelines, such as Good Clinical Data Management Practices (GCDMP) and Good Clinical Practice (GCP).

By familiarizing yourself with the interview questions and utilizing the suggested strategies and tips provided, you will be well-prepared to articulate your knowledge, skills, and experience in CDM during your interviews. This resource aims to enhance your interview performance and increase your chances of securing a position in the competitive field of Clinical Data Management.

Whether you are applying for a CDM role in a pharmaceutical company, contract research organization (CRO), or academic institution, CDM Interview Question Part I is an invaluable tool to help you navigate the interview process and stand out as a strong candidate.

1. Interview Preparation Questions Clinical Data Management 16-06-2023 www.clinosol.com | [email protected] 1 PART II Prepared By:- Ankita Kumari M. Pharm Clinosol Student ID-026/022023

2. 16-06-2023 www.clinosol.com | [email protected] 2 What are data points in AE forms? 1 What are email alerts? Give some examples of email alert 2 What is the primary reason for disposition? 3 What is the status form? 4 What is an Auto query? Give the reason for the auto query 5 What is CCG’s (CRF completion guidelines) 6 What is mapping? 7 What are dynamics? Give some examples of dynamics 8 What is a manual query? 9 Give some examples of Manual queries. 10 INDEX

3. 1. What are data points in AE forms? 16-06-2023 www.clinosol.com | [email protected] 3 AE ID AE term AE start date and time Ongoing Seriousness criteria Outcome of AE Action taken with study drug

4. 2. What are email alerts? Give some examples of email alert 16-06-2023 www.clinosol.com | [email protected] 4 An email alerts is an SAE ALERTS. If any adverse event is serious adverse event email should trigger, this is known as Email alert. E.g.

5. 3. What is the primary reason for disposition? 16-06-2023 www.clinosol.com | [email protected] 5 Reason for disposition includes:- Not signing the ICF Screen failure Investigator terminated trial SAE Withdrawn by the subject Loss of follow up Protocol deviation

6. 4. What is the status form? 16-06-2023 www.clinosol.com | [email protected] 6

7. 5. What is an Auto query? Give the reason for the auto query 16-06-2023 www.clinosol.com | [email protected] 7 Auto query/Edit checks – The Auto query/Edit checks are needed to validate the data which is entered, sometimes the data may be missing, incomplete, inaccurate, illogical, or inconsistent. Example of MH (Medical history) Form MH start date: 01/11/1986 ICF start date: 02/11/1986 valid data The situation is valid no need to query. MH start date: 30/03/2022 Date of birth: 31/03/2022 Invalid data LOGIC – MH start date is before the date of birth then fire a query. Query text – MH start date is before the date of birth please correct or clarify.

8. 6. What is CCG’s (CRF completion guidelines) 16-06-2023 www.clinosol.com | [email protected] 8 A CRF completion guideline is  a document to assist the investigator to complete the CRF in a step-by-step manner  and is drafted concurrently in line with the CRF and protocol. CCGs assure accurate and complete collection of data.

9. 7. What is mapping? 16-06-2023 www.clinosol.com | [email protected] 9 Data mapping is the process of matching fields from one database to another. It's the first step to facilitate data migration, data integration, and other data management tasks.

10. 8. What are dynamics? Give some examples of dynamics 16-06-2023 www.clinosol.com | [email protected] 10 Triggering of forms or visits based on satisfaction of criteria is called Dynamics.

11. 9. What is a manual query? 16-06-2023 www.clinosol.com | [email protected] 11 Manual query – Manual queries are not auto queries. It should be raised by the Data manager, CRA or statistician. Manual queries are raised, based on the review of the auto-put data which is pulled from the system. Manual queries are not auto-closed and the sponsor has to manually close the query. Manual query is raised and reissued and closed by Clinical Data Manager or CRA.

12. 10. Give some examples of Manual Queries. 16-06-2023 www.clinosol.com | [email protected] 12 Example of manual Query – AE id – 02 AE term – fever AE start date – 20/04/2022 AE end date – 25/04/022 MH id – 10 MH term – fever MH start date – 22/04/2022 MH end date – 26/04/022 This duplicate record. If the record is duplicated, it raises a manual query. Data manager will review the data and will raise the manual query. Query text – AE and MH records are possibly duplicate please correct or clarify.

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