CCDM Exam Dumps : Certified Clinical Data Manager

When electronic patient-reported outcomes (ePRO) devices are used, data are captured directly by subjects through validated devices and transmitted electronically to the study database. To ensurereal-time data quality control,programmed edit checksshould be implementedat the point of data entry— that is, as subjects input data into the device.

According toGood Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning),front-end programmed edit checksare the optimal method to prevent entry of invalid or out-of-range values in ePRO systems. This helps maintain data accuracy at the source, minimizing downstream queries and data cleaning workload.

OptionsAandBinvolve post-submission or manual review, which is less efficient and not compliant with the principle offirst-pass data validation.Option C(visualization) is a valuable secondary QC method for trends, but not for immediate data validation.

Therefore,option Dis correct —programmed edit checks upon data entryensure immediate validation and higher data integrity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 5.3 – Automated Edit Checks and Front-End Validation

ICH E6(R2) GCP, Section 5.5.3 – Computerized System Controls and Validation

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations (2013), Section 6 – Real-Time Data Quality Control

RACIis aproject management and governance frameworkused to defineroles and responsibilitieswithin a project. Each letter represents a distinct role type:

Responsible (R):The person(s) who perform the work or execute the task.

Accountable (A):The individual ultimately answerable for the task’s completion and success (only one per activity).

Consulted (C):Subject matter experts who provide input or guidance before decisions are made.

Informed (I):Individuals kept up to date on progress or outcomes but not directly involved in execution.

The RACI model ensuresclarity in ownership and accountability, preventing duplication of effort or responsibility confusion. It is a key component of theGCDMP (Chapter: Project Management in Data Management)for ensuring clear delegation and communication within clinical data management teams.

Hence,option Dis correct.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Project Management in Data Management, Section 5.1 – Roles, Responsibilities, and RACI Matrices

Project Management Institute (PMI) Framework – Responsibility Assignment Matrices (RACI)

ICH E6(R2) GCP, Section 5.1.1 – Defined Roles and Quality Oversight Responsibilities

For a well-maintained 100-subject study withongoing data cleaningandcompleted reconciliations, thedatabase lockprocess typically takesa few daysafter theLast Patient Last Visit (LPLV).

According to theGCDMP (Chapter: Database Lock and Archiving), the duration of the lock process depends on the level of data cleanliness at LPLV. If the study team has conducted continuous data cleaning, query resolution, and external data reconciliation throughout the trial, then the final lock steps (e.g., final data review, documentation, and approvals) can be completed in2–5 days.

However, if significant cleaning or reconciliation remains outstanding, lock may take several weeks. Since the question states that data are “maintained almost all clean,”Option B – a few days– is the appropriate estimate.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 6.2 – Database Lock Preparation and Timelines

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Quality and Lock Procedures

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Lock and Archiving Procedures