ACRP ACRP-CP Dumps

Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high-quality, reliable, and verifiable clinical trial records.

GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.

"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards."

Objectives:

Maintain data integrity and reliability.

Adhere to best practices in clinical documentation.

The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study’s outcomes.

GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.

"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity."

Objectives:

Ensure comprehensive data recording.

Maintain accuracy and completeness in study records.

Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.

GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.

"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups."

Objectives:

Maintain scientific rigor through randomization.

Minimize selection bias in clinical studies.