Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project.

Black, Joanna; Julier, Patrick; Eldridge, Lucy; Barber, Vicki S

Black, Joanna; Julier, Patrick; Eldridge, Lucy; Barber, Vicki S.

Affiliation

Black J; Oxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LF, UK. joanna.black@ndorms.ox.ac.uk.
Julier P; Oxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LF, UK.
Eldridge L; Oxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LF, UK.
Barber VS; Oxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LF, UK.

Trials ; 25(1): 503, 2024 Jul 24.

Article in En | MEDLINE | ID: mdl-39044237

Subject(s)

Adverse Drug Reaction Reporting Systems; Humans; Data Collection; Clinical Trials as Topic/methods; Drug-Related Side Effects and Adverse Reactions; United Kingdom; Time Factors

Key words

REDCap; Regulatory compliance; SAE collection; SAE processing; SAE reporting; SUSAR

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Adverse Drug Reaction Reporting Systems Limits: Humans Country/Region as subject: Europa Language: En Journal: Trials Journal subject: MEDICINA / TERAPEUTICA Year: 2024 Type: Article Affiliation country: United kingdom

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