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SCDM CCDM Exam - Topic 3 Question 18 Discussion

When implementing a study utilizing an EDC application, it would be appropriate to use free text fields for which of the following?
B) Adverse event verbatim term
A) Urine sedimentation rate
C) Date of birth
D) Body Mass Index

SCDM CCDM Exam - Topic 3 Question 18 Discussion

Actual exam question for SCDM's CCDM exam
Question #: 18
Topic #: 3
[All CCDM Questions]

When implementing a study utilizing an EDC application, it would be appropriate to use free text fields for which of the following?

Show Suggested Answer Hide Answer
Suggested Answer: B

In Electronic Data Capture (EDC) systems, free text fields should be used only when a predefined list of acceptable responses cannot accommodate the full variability of input data --- most notably for Adverse Event (AE) verbatim terms.

According to the Good Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), AE verbatim terms are initially entered as free text by site staff to accurately capture the investigator's exact medical description of the event. These verbatim terms are later coded using standardized dictionaries such as MedDRA during medical coding, ensuring both flexibility and standardization in reporting.

Conversely, fields such as urine sedimentation rate (A), date of birth (C), and Body Mass Index (D) require structured numeric or date formats to enable validation, range checks, and consistency across datasets. Free text would compromise data integrity, accuracy, and validation efficiency for these structured data elements.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.3 -- Use of Free Text and Coded Fields

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 -- Data Structure and Validation

MedDRA Introductory Guide, Section 2.3 -- Verbatim Entry and Coding Requirements


Contribute your Thoughts:

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Chaya
3 days ago
But A and D are specific measurements. Why not use them?
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Margery
8 days ago
Agreed! Free text captures nuances better.
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Refugia
14 days ago
I think B is the best choice. Adverse events need detailed descriptions.
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Cassi
19 days ago
B) makes sense, but I thought we needed standard terms.
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Malinda
24 days ago
C) Date of birth should never be free text!
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Lorenza
29 days ago
Wait, can we really use free text for that?
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Ty
1 month ago
I disagree, A) should be a fixed field too.
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Enola
1 month ago
Definitely B) Adverse event verbatim term.
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Ollie
1 month ago
I recall we had a similar question in our review, and it was about using free text for open-ended responses. B seems like the most logical choice here.
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Marjory
2 months ago
I feel like free text fields shouldn't be used for standardized data like C) Date of birth or D) Body Mass Index. But I'm not completely confident.
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Angella
2 months ago
I'm not entirely sure, but I remember a practice question where we discussed using free text for things that vary a lot, like symptoms. So, B might be right.
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Kiera
2 months ago
I think free text fields are best for capturing detailed descriptions, so maybe B) Adverse event verbatim term? That seems to fit.
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