SCDM CCDM Exam - Topic 1 Question 4 Discussion

Actual exam question for SCDM's CCDM exam

Question #: 4
Topic #: 1

[All CCDM Questions]

During an inspection to determine appropriate documentation for use of a computerized system, what SOP might the inspector expect to find?

AData management plan

BData backup plan

CStatistical analysis plan

DEdit specifications

Show Suggested Answer

Suggested Answer: B

During a regulatory inspection, inspectors expect to find documented Standard Operating Procedures (SOPs) governing the use, validation, and maintenance of computerized systems, including data backup and recovery procedures.

According to the GCDMP (Chapter: Computerized Systems and Compliance) and FDA 21 CFR Part 11, organizations must maintain an SOP that ensures data protection against loss, corruption, or unauthorized access. The SOP should describe backup frequency, secure storage, verification of backup integrity, and procedures for data restoration.

While the Data Management Plan (A) and Edit Specifications (D) are study-level documents, and the Statistical Analysis Plan (C) focuses on analysis procedures, only a Data Backup Plan (B) constitutes a required system-level SOP ensuring compliance and data continuity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 5.2 -- Data Security, Backup, and Recovery SOPs

FDA 21 CFR Part 11 -- Subpart B, Controls for Closed Systems

ICH E6(R2) GCP, Section 5.5.3 -- System Security, Data Backup, and Recovery Requirements

by Bernardine at Nov 24, 2025, 04:09 AM

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Marci

9 hours ago

I think a data backup plan is more critical.

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Barbra

6 days ago

Definitely a data management plan!

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Jettie

11 days ago

Option C is a bit of a stretch. A statistical analysis plan is more likely to be found in a research study, not a routine inspection of a computerized system.

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Kaitlyn

16 days ago

Haha, the inspector is probably hoping to find a "coffee and donut" plan too, just to make the inspection a little more enjoyable!

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Ludivina

21 days ago

I'm not sure about that. Wouldn't the inspector also expect to find edit specifications to ensure the data is properly formatted and validated?

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Fernanda

26 days ago

I agree with Marci. A data backup plan is essential for ensuring the integrity and availability of the computerized system's data.

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Marci

1 month ago

Option B is the correct answer. The inspector would expect to find a data backup plan during the inspection.

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Chana

1 month ago

I feel like a Statistical analysis plan could be important too, but it seems less likely than the others.

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Starr

1 month ago

I practiced a question similar to this, and I think Edit specifications might also be relevant, but I'm not confident.

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Pansy

2 months ago

I'm not entirely sure, but I remember something about needing a Data management plan for computerized systems.

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Twana

2 months ago

Okay, I think I've got this. The key is focusing on the documentation the inspector would expect to see for a computerized system. That narrows it down to the data management plan or the data backup plan. I'll go with B) Data backup plan.

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Britt

2 months ago

Data management and backup plans seem like the most logical choices here. I'd probably start by reviewing those options and trying to determine which one is the best fit based on the context of the question.

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Blondell

2 months ago

I think a data management plan is crucial.

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Teri

2 months ago

I think the inspector would definitely look for a Data backup plan since it's crucial for data integrity.

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Shaun

2 months ago

I'm a bit unsure on this one. The options seem to cover a range of documentation, but I'm not totally clear on which one would be most relevant for an inspection of a computerized system. Guess I'll have to think it through carefully.

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Jesse

3 months ago

Okay, let's see. I'm guessing the inspector would want to see an SOP that covers the data-related aspects, so I'm leaning towards either the data management plan or the data backup plan.

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Laurene

3 months ago

Hmm, this seems like a tricky one. I'd probably start by thinking about the key documentation needed for a computerized system - things like data management, backups, and system specifications.

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Portia

3 months ago

Definitely! But what about the data backup plan?

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Callie

3 months ago

I think a data management plan is crucial.

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