Q: 5
Which of the following statements would be BEST included in a data management plan describing
the process for making self-evident corrections in a clinical database?
Options
Discussion
Option D
D . The conventions for making self-evident corrections should be listed and anything changed must be documented to the investigative site for proper transparency, that's in line with GCDMP. B misses that external notification part, so doesn't fully meet best practice. Think D's the exam-safe pick but happy if anyone sees it another way.
It’s D, pretty tired of these GCDMP nitpickers but site documentation is always needed per reports.
D fits here since it's not just about internal approval but also documenting to the site, which aligns with GCDMP transparency. B lacks that external step. Pretty sure D matches what the exam wants but open to pushback.
D , that's what you'd see in official guides and most practice material. Self-evident corrections need conventions plus site documentation, not just internal review. If you want to check, official sample questions usually word it almost exactly like D. Not 100% but feel confident.
D tbh, B looks tempting but trap option since it misses documenting at the site which is required for self-evident corrections here.
D fits because it makes sure corrections follow set conventions and are documented to the site, which is key per GCDMP standards. The others skip either the conventions or contacting the site. Pretty sure about D but open if someone has a good counterpoint.
Yeah D, since you need both clear conventions and to let the site know. The others skip at least one requirement.
That flips if the convention doesn't actually define "self-evident" up front, so maybe D only applies if the plan spells it out clearly. D
D locks in both required parts: following conventions for self-evident corrections and making sure those changes are documented to the site. GCDMP is all about predefined rules plus transparency with the investigator, not just internal review like B. That's why D is safer, though if this was about strictest control, C might be closer. Pretty sure D covers what they want, but happy to hear other takes.
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