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e-Pathway: Project Management
Overview
Budget monitoring
Budget monitoring
Chief Investigators are responsible for the management of their research grants and it is important to ensure appropriate monitoring of the budget and compliance with funder requirements e.g. regular reporting in lien with expected timeframes.
Colleagues in Research Finance will support the administration of externally funded research project accounts once an award has been received and accepted by the University. For further information and contacts, visit the Research Finance team's SharePoint pages.
The University’s online platform for managing research grants is called Worktribe. This system needs to be used for all research bids being made to any funding body or organisation. You can access Worktribe online.
Vendor management
Vendor management
There may be some research functions that the researcher needs to delegate to a vendor for example database development, medicinal product supply, laboratory analysis. The functions to be delegated need to be documented and any necessary vendor assessments performed.
The researcher will need to retain evidence of communication with the vendor and documented oversight to ensure contract compliance throughout the project.
Where the vendor is a medicinal product supplier consideration should be given to:
- IMP/medical devices: ongoing supply, return and destruction
- Supply management system, supply order, shipment, return and/or destruction forms
- See the UoB Medicinal Product Management SOP (UoB-MED-SOP-001) (Word, 406 KB) .
Where the vendor is a laboratory consideration should be given to:
- This Laboratory Self-Assessment Questionnaire is mandatory for all new laboratories (internal and external to the University) that are being considered for use in a CTIMP. Completion of the questionnaire will help to provide assurance that the laboratory is able to meet the requirements of GCP. Please see the associated guidance document on the use and implementation of the questionnaire
- See the Laboratory Self-Assessment Questionnaire (Word, 315 KB)
- See the Laboratory Self-Assessment Questionnaire Guidance for CTUs (Word, 310 KB)
- See the Laboratory Set Up and Management (UoB-CRL-SOP-001) (Word, 360 KB).
- See also the External Laboratory Set-up and Oversight (UoB-CRL-SOP-006) (Word, 364 KB).
Site management
Site management
Central to the success of clinical research is the effective management of investigator sites.
Sites must have access to the latest approved versions of the protocol, participant information sheet (PIS)/informed consent form (ICF), case report form (CRF) and project-specific manual(s)/guidelines in the investigator site file (ISF). Further information can be found in the UoB Investigator Site Management SOP (UoB-SMA-SOP-001) (Word, 317 KB) .
Within the UoB clinical research QMS there is an essential document checklist that can be used to identify which documents should be filed in the ISF. See the UoB Essential Documents Development and Maintenance SOP (UoB-ESD-SOP-001) (Word, 401 KB) and the UoB Essential Documents Checklist (UoB-ESD-QCD-005) (Word, 303 KB) for further information.
The ISF will also include reports from/to sites, correspondence with sites, evidence of project management group meetings and the completed site signature and delegation log. See UoB Site Signature and Delegation Log Template (UoB-SMA-QCD-001) (Word, 295 KB) for information.
See also 'site permissions' in the Project Setup - Governance & Ethics of the e-Pathway.
Participant recruitment monitoring
Participant recruitment monitoring
Participant recruitment is essential for the successful conduct of your project and should be monitored against agreed milestones to understand as soon as possible if the recruitment strategy is successful and in line with expectations. If issues are identified, a change to the recruitment strategy might need to be considered.
If your project has received NIHR portfolio adoption, it is essential to work closely with colleagues from the Clinical Research Network to ensure appropriate data management on the CPMS system.
Data management
Data management
The data generated from a clinical research project plays a fundamental role in determining the outcome of the research, and subsequently the direction of future research. It is therefore vital that the data management processes are robust enough to ensure that the data being collected and reported is to the highest of standards, accurately reflecting the research being carried out. Data management tools, such as a data management plan, databases and data clarification forms should be developed to help ensure high quality data.
As clinical research typically involves the collection of personal data, processes to manage personal data and the requirements of the General Data Protection Regulation (GDPR) are important.
Further information
See the UoB Data Management SOP (UoB-DMA-SOP-001) (Word, 732 KB) and the UoB Data Management Policy for more information on the requirements relating to data management.
Lab management
Lab management
For information on lab management, see the Human Tissue & Data page of the e-Pathway.
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e-Pathway Index
e-Pathway Index
The clinical research e-Pathway provides a roadmap to guide researchers during the lifetime of their research projects. Click on the links to take yourself to the stage that is of interest. You can also use the roadmap image on each page for navigation.
From Idea to Proposal
Applying for Funding (current page)
Project Setup
Green Light - Ready to Go?
Project Management (current page)
Project End
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