Apr 19, 2023
LEGACY01: STUDY MANAGEMENT
- Katrina M Pollock1,
- Calliope Dendrou2
- 1NIHR Imperial Clinical Research Facility, ICTEM Building, Hammersmith Hospital Campus, Du Cane Road, London W12 0HS, UK;
- 2Wellcome Centre for Human Genetics, University of Oxford, Oxford OX3 7BN
- Katrina M Pollock: Chief Investigator;
- Calliope Dendrou: Scientific Lead
Protocol Citation: Katrina M Pollock, Calliope Dendrou 2023. LEGACY01: STUDY MANAGEMENT. protocols.io https://dx.doi.org/10.17504/protocols.io.kxygx9n7og8j/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: January 11, 2023
Last Modified: April 19, 2023
Protocol Integer ID: 75108
Keywords: Single-cell sequencing, lymph node, influenza vaccine, ancestry
Funders Acknowledgement:
Chan Zuckerberg Initiative
Grant ID: DAF2022-239944
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Abstract
This protocol details study management in an experimental medicine study of seasonal influenza vaccination responses in Lymph nodE single-cell Genomics in AnCestrY (LEGACY01).
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Guidelines
STUDY MANAGEMENT
The day-to-day management of the study will be co-ordinated through NIHR Imperial CRF and the study manager Aime Palomeras.
LABORATORY DATA RECORDING AND MONITORING
Laboratory data management for the study will be co-ordinated by Calli Dendrou, Brian Marsden and Teresa Lambe at the University of Oxford. Data will be stored with linked anonymised (pseudonymised) codes, and all files and databases will be password protected and held on password protected computers. Pseudanonymised identifiers will be kept on a secured NHS workstation at NIHR Imperial CRF before transfer of the minimally required demographic metadata (e.g. sex and age) to study scientists in Oxford.
Raw and analysed sequencing, genetic, flow cytometric and serological data will be collated and stored on a restricted access site on a University of Oxford computational cluster (BMRC) and will be managed and curated according to established protocols. The storage system of the computational cluster is resilient to disk failure and data are automatically backed up to linked off-site servers. Data files will be clearly labelled and associated (cleaned and anonymised) metadata will be stored in tab-delimited text files so as to document the provenance of the data. Where automated analyses are performed, these will be version controlled and the commands used will be recorded in log files. Data arising from smaller-scale laboratory analyses will be recorded in hard copy or electronic laboratory notebooks according to standard University practices. Data (and analysis scripts) will be maintained in this way for ten years after study completion.
PROJECT MANAGEMENT AND GOVERNANCE
Imperial College London and University of Oxford are the principal partners for delivery of the study in the UK. These two institutions will partner with Uganda Virus Research Institute (UVRI), who will be responsible for international capacity building to undertake future single-cell and lymphatic tissue focussed vaccine research under the umbrella of the LEGACY Network.