Guidance
Guidelines for the Content of Statistical Analysis Plans in Clinical Trials – 2017 [JAMA. 2017;318(23):2337-2343.doi:10.1001/jama.2017.18556.]
Early phase clinical trials extension to guidelines for the content of statistical analysis plans [BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-068177 (Published 07 February 2022)]
Considerations for a Participant Data Sharing SOP [March 2021]
Reports & Publications
e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidenceTrials24, 657 (2023). https://doi.org/10.1186/s13063-023-07656-8 [October 2023] – As part of the e-Consent collaborative group
Editorial – Guidelines for Statistical Analysis Plans – 2017 [JAMA. 2017;318(23):2301-2303. doi:10.1001/jama.2017.18954.]
Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences – 2015 [Clin Trials. 2015 Dec;12(6):664-76. doi: 10.1177/1740774515589959.]
Training
Good Statistical Practice – Tailored GCP Training for Statisticians
~ Module 1 – Core Good Clinical Practice training
~Module 2 – Record keeping and documentation
~Module 3 – Trial design, randomisation and blinding
~Module 4 – Data Management
~Module 5 – Statistical analysis and reporting
Collaborate
UKCRC Registered CTU Network Search for Oversight Statistician Database [Made available December 2016]
~ To register or access the database please click here.
Membership
For a list of current Statistic Operations Group members please click here.
