Discuss SCDM CCDM Exam Topic 5 Question 15

A Data Manager is importing lab data for a study. The lab data and the associated audit trail is kept at the central lab. What is necessary to maintain traceability of the transferred data at the Data Manager's location?

AMaking changes only after data have been imported

BMaintaining a copy of the data as received

CMaking changes only for exceptions

DMaking changes only on the copy of the received data

Suggested Answer: B

Maintaining traceability of external data imports (such as laboratory results) is a fundamental principle of clinical data management. According to the GCDMP (Chapter: External Data Transfers and Integration), Data Managers must retain an unaltered copy of the raw data exactly as received from the vendor.

This archived version serves as a reference for:

Data provenance verification,

Audit trail review, and

Discrepancy resolution between vendor and study database.

Since the central lab maintains its own audit trail, the Data Manager's responsibility is to preserve the original data transmission file before applying transformations, merges, or validations.

Options A, C, and D describe procedural safeguards but do not meet the regulatory requirement of traceable data lineage. Only option B (Maintaining a copy of the data as received) ensures compliance with ICH E6(R2) and FDA 21 CFR Part 11 standards for data traceability and integrity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: External Data Transfers and Integration, Section 5.2 -- Data Traceability and Version Control

ICH E6(R2) GCP, Section 5.5.3 -- Data Integrity and Source Data Verification

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 -- Source Data Traceability and Archiving

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22 comments · newest first

Rosendo 2 days ago

I feel like option A is risky. Changes after import can lead to errors.

Sharee 7 days ago

Option D makes sense too. Changes should be on a separate copy.

Gladys 12 days ago

Agreed! Without a copy, how can we verify data integrity?

Wai 17 days ago

I think option B is crucial. Keeping a copy helps track changes.

Ben 23 days ago

Surprised this is even a question, isn't it obvious?

Glendora 28 days ago

I agree, keeping the original intact is crucial for traceability!

Josephine 1 month ago

Wait, why would you change the original data at all?

Annice 1 month ago

I think making changes only for exceptions is a good practice too.

Trina 1 month ago

Definitely need to maintain a copy of the data as received.

Angelo 2 months ago

D sounds like a good practice, but how do we ensure accuracy?

Celeste 2 months ago

Wait, can you really just change data after importing?

Detra 2 months ago

C seems a bit risky, changes should be documented.

Sena 2 months ago

I think A is also important, but not as much as B.

Lorean 2 months ago

B is definitely necessary to keep track of the original data.

Whitley 2 months ago

I feel like making changes only after data have been imported could lead to issues. I wonder if that’s the best approach for maintaining traceability.

Carolann 3 months ago

I’m leaning towards option B, but I also recall something about making changes only on the copy of the received data. It’s a bit confusing.

Carli 3 months ago

I remember a practice question where we discussed making changes only for exceptions. It seems relevant, but I feel like it might not cover everything.

Brittney 3 months ago

I think maintaining a copy of the data as received is crucial for traceability, but I'm not entirely sure if that's the only thing needed.

Gennie 3 months ago

I think making changes only for exceptions might be a safe option, but it seems like it could complicate things if not handled properly.

Matthew 3 months ago

I feel like making changes only after data have been imported could lead to issues, but I can't remember why exactly.

Nikita 4 months ago

I remember a practice question that emphasized making changes only on the copy of the received data, but I can't recall if that was the best approach here.

Lura 5 months ago

I think maintaining a copy of the data as received is crucial for traceability, but I'm not entirely sure if that's the only thing needed.

SCDM CCDM Exam - Topic 5 Question 15 Discussion