Clinical researchers' lived experiences with data quality monitoring in clinical trials: a qualitative study.

ABSTRACT:

Background

Fundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials.

Methods

We conducted semi-structured telephone interviews following a guided-phenomenological approach. Participa

SUBMITTER: Houston L 

PROVIDER: S-EPMC8454069 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature