Discuss SCDM CCDM Exam Topic 1 Question 4

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

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

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30 comments · newest first

Kristeen 6 months ago

All options are relevant, but I lean towards data backup.

Eun 6 months ago

Statistical analysis plan is important for results.

Royal 6 months ago

I feel like edit specifications are often overlooked.

Bronwyn 6 months ago

But what about the data backup plan? That's essential too.

Margot 6 months ago

Definitely! It outlines how data is handled.

King 7 months ago

I agree, but I thought statistical analysis was more important.

Tommy 7 months ago

Edit specifications are a must-have too!

Erick 7 months ago

Wait, are we really expected to have all these plans?

Marci 8 months ago

I think a data backup plan is more critical.

Barbra 8 months ago

Definitely a data management plan!

Jettie 8 months 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.

Kaitlyn 8 months ago

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

Ludivina 8 months 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?

Fernanda 8 months ago

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

Marci 9 months ago

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

Chana 9 months ago

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

Starr 9 months ago

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

Pansy 9 months ago

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

Twana 9 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.

Britt 9 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.

Blondell 10 months ago

I think a data management plan is crucial.

Teri 10 months ago

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

Shaun 10 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.

Jesse 11 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.

Laurene 11 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.

Kris 5 months ago

↳ replying to Laurene

I’d lean towards the data backup plan for sure.

Hyun 5 months ago

↳ replying to Laurene

Statistical analysis plan might not be the first choice.

Mariann 6 months ago

↳ replying to Laurene

Edit specifications could be important too.

Portia 10 months ago

↳ replying to Laurene

Definitely! But what about the data backup plan?

Callie 10 months ago

↳ replying to Laurene

I think a data management plan is crucial.

SCDM CCDM Exam - Topic 1 Question 4 Discussion