Discuss SCDM CCDM Exam Topic 2 Question 2

There is a modification to the CRF and a sudden increase in the number of queries generated in the EDC system. Which action is most likely to reduce the number of queries?

AMake some of the existing edit checks manually

BIntroduce a source data verification process

CReview the edit checks for correctness

DHave the monitor close the queries

Suggested Answer: C

When a CRF modification leads to a sudden increase in EDC queries, the most likely cause is an error or misconfiguration in the edit checks introduced during or after the change. Therefore, the first step should be to review the edit checks for correctness.

The GCDMP (Chapter: Database Design and Validation) emphasizes that any database or CRF modification should trigger retesting of affected validation rules. Incorrect logic, thresholds, or missing conditional statements in automated edit checks can cause false or redundant queries, leading to unnecessary data management burden and site frustration.

Manually handling edit checks (option A) or adding SDV (option B) does not address the root cause. Having monitors close queries (option D) would mask the problem rather than resolve it.

Thus, the correct corrective measure is Option C --- review and validate the edit checks to ensure proper functionality.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Validation, Section 5.5 -- Edit Check Testing and Review

ICH E6 (R2) GCP, Section 5.5.3 -- Validation and Change Control for Electronic Systems

FDA 21 CFR Part 11 -- System Validation and Change Documentation

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31 comments · newest first

Dalene 6 months ago

D just delays the problem.

Jaclyn 6 months ago

B seems too complex for quick fixes.

Yolando 6 months ago

A could work too, but it's manual.

Jin 6 months ago

Reviewing edit checks can fix errors.

Novella 6 months ago

Why C?

Elli 7 months ago

Manual edit checks could lead to more errors, not less!

Timothy 7 months ago

Wait, how did the number of queries increase so suddenly?

Mireya 7 months ago

Not so sure about that, closing queries might just hide the problem.

Emeline 8 months ago

Totally agree, option C is the way to go!

Nada 8 months ago

C is the clear winner here. Gotta make sure those edit checks are up to snuff.

Yuriko 8 months ago

Haha, option D? Really? Let's not just have the monitor close the queries and call it a day.

Coral 8 months ago

I'd go with C. Gotta make sure those edit checks are on point.

Elenore 8 months ago

Option C is the way to go. Reviewing the edit checks will help identify and fix any issues.

Joseph 8 months ago

I recall a practice question where closing queries by the monitor didn’t really solve the underlying issue, so I’m hesitant about that option.

Adolph 9 months ago

I feel like making some edit checks manual could reduce queries, but I worry it might lead to more errors instead.

Della 9 months ago

I think introducing a source data verification process might help, but it seems like it could also complicate things further.

Ling 9 months ago

I remember discussing how reviewing edit checks for correctness could help reduce queries, but I'm not entirely sure if that's the best first step.

Gilma 9 months ago

Making the edit checks manual is an interesting idea, but that could introduce more room for error. I think the best option is to thoroughly review the checks and make any necessary corrections.

Reena 9 months ago

Okay, I've got a strategy here. I'd start by reviewing the edit checks to see if there are any issues or areas for improvement. That seems like the most direct way to reduce the number of queries.

Rory 9 months ago

Hmm, closing the queries through the monitor doesn't seem like it will address the root cause. We need to look at the edit checks and make sure they're functioning properly.

Jin 10 months ago

I think C is the best choice.

Elden 10 months ago

I think reviewing the edit checks for correctness makes the most sense.

Christoper 10 months ago

I agree with C, it addresses root issues.

Matthew 10 months ago

C seems like the most logical choice. Fixing the edit checks is key.

Tracey 11 months ago

I'm a bit confused on this one. Is the issue with the CRF modification or the EDC system? I'm not sure if introducing source data verification is the right move without more information.

Stephaine 11 months ago

I think reviewing the edit checks for correctness is the best approach here. That will help identify any issues with the existing checks that could be causing the increase in queries.

Alesia 5 months ago

↳ replying to Stephaine

Closing queries won't solve the root issue.

Carma 5 months ago

↳ replying to Stephaine

That might help too, but it seems more complex.

Vonda 5 months ago

↳ replying to Stephaine

But what about introducing source data verification?

Golda 6 months ago

↳ replying to Stephaine

Yeah, it could really pinpoint the problems.

Dick 10 months ago

↳ replying to Stephaine

I agree, reviewing the edit checks sounds smart.

SCDM CCDM Exam - Topic 2 Question 2 Discussion