Sly Saint
Senior Member (Voting Rights)
Abstract
Background
Trial monitoring is an important component of good clinical practice to ensure the safety and rights of study participants, confidentiality of personal information, and quality of data. However, the effectiveness of various existing monitoring approaches is unclear. Information to guide the choice of monitoring methods in clinical intervention studies may help trialists, support units, and monitors to effectively adjust their approaches to current knowledge and evidence.
Objectives
To evaluate the advantages and disadvantages of different monitoring strategies (including risk‐based strategies and others) for clinical intervention studies examined in prospective comparative studies of monitoring interventions.
Search methods
We systematically searched CENTRAL, PubMed, and Embase via Ovid for relevant published literature up to March 2021. We searched the online 'Studies within A Trial' (SWAT) repository, grey literature, and trial registries for ongoing or unpublished studies.
Selection criteria
We included randomized or non‐randomized prospective, empirical evaluation studies of different monitoring strategies in one or more clinical intervention studies. We applied no restrictions for language or date of publication.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.MR000051.pub2/full
Background
Trial monitoring is an important component of good clinical practice to ensure the safety and rights of study participants, confidentiality of personal information, and quality of data. However, the effectiveness of various existing monitoring approaches is unclear. Information to guide the choice of monitoring methods in clinical intervention studies may help trialists, support units, and monitors to effectively adjust their approaches to current knowledge and evidence.
Objectives
To evaluate the advantages and disadvantages of different monitoring strategies (including risk‐based strategies and others) for clinical intervention studies examined in prospective comparative studies of monitoring interventions.
Search methods
We systematically searched CENTRAL, PubMed, and Embase via Ovid for relevant published literature up to March 2021. We searched the online 'Studies within A Trial' (SWAT) repository, grey literature, and trial registries for ongoing or unpublished studies.
Selection criteria
We included randomized or non‐randomized prospective, empirical evaluation studies of different monitoring strategies in one or more clinical intervention studies. We applied no restrictions for language or date of publication.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.MR000051.pub2/full