e-Pathway: Project Management

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 intranet 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.

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. 

• See the UoB Compliance Review SOP (UoB-CPR-SOP-001) (Word - 96 KB).

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: 

• Whether this laboratory has been used by UoB before and whether its suitability has been assessed. If the laboratory is new an External Laboratory Self-Assessment Questionnaire (UoB-CRL-QCD-025) (Link via Contensis) will need completing by the laboratory’s management to determine if appropriate processes are in place to be capable of working to GCP in the laboratory standard. If the laboratory has been used before confirmation that the details in the initial questionnaire are still accurate will need to be obtained
• 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).

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 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.

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.

For information on lab management, see the Human Tissue & Data page of the e-Pathway.

The clinical research e-Pathway provides a roadmap to the various stages and sub-stages that a researcher may follow during the lifetime of their research project. Click on a link to take yourself to the stage that is of interest, or you can use the roadmap image on each page to navigate through the process.  

From Idea to Proposal

Applying for Funding

Project Setup

• Governance & Ethics
• Essential Documents
• Human Tissue & Data

Green Light - Ready to Go?

Project Management (current page)

• Quality & Oversight
• Adverse Events & Deviations
• Amendments

Project End

• Maximising Impact

Need help with your project? See the 'who can help?' section. 

For an overview of the e-Pathway, return to the homepage.