In data integrity, what is the CRC responsible for?

In data integrity, what is the CRC responsible for?

• A. Audit financials.
• B. Design case report forms.
• C. Approve data analysis plan.
• D. Ensure accurate, complete, and timely documentation.

Answer: (D)

Data integrity centers on keeping study data accurate, complete, and timely, with records that are traceable and verifiable. The clinical research coordinator ensures that documentation reflects what happened, when, and by whom, maintaining source documents and entries that are complete and contemporaneous. This focus preserves data quality by preventing gaps, errors, and delays and aligns with principles like ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate). The tasks listed in the other options fall to different roles—financial audits to finance or audit teams, designing case report forms to data management or study design staff, and approving the data analysis plan to the sponsor, PI, or biostatisticians—so they don’t directly address maintaining the integrity of the data through proper, timely documentation.

Data integrity centers on keeping study data accurate, complete, and timely, with records that are traceable and verifiable. The clinical research coordinator ensures that documentation reflects what happened, when, and by whom, maintaining source documents and entries that are complete and contemporaneous. This focus preserves data quality by preventing gaps, errors, and delays and aligns with principles like ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate). The tasks listed in the other options fall to different roles—financial audits to finance or audit teams, designing case report forms to data management or study design staff, and approving the data analysis plan to the sponsor, PI, or biostatisticians—so they don’t directly address maintaining the integrity of the data through proper, timely documentation.