e-Pathway: Project Setup

As the design of the project moves forward towards the point of submission for regulatory approvals, the protocol will be nearing finalisation. With the protocol more clearly defined, the topics/areas below should be considered in accordance with the related SOP(s). This is not a definitive list but are some of the key areas of focus during sponsorship review.  

• Participant entry, randomisation, blinding and emergency unblinding: decide on processes as applicable. See UoB Randomisation & Blinding SOP (UoB-RND-SOP-001) (Word - 126 KB).
• IMP/medical devices sourcing and management. See UoB Medicinal Product Management SOP (UoB-MED-SOP-001) (Word - 406KB).
• Statistics analysis plan development. See UoB Statistics SOP (UoB-CRT-STA-SOP-001) (Word - 137 KB).
• Adverse Event reporting: decide on processes surrounding classification, communication pathways for reporting and trend analysis. See UoB Adverse Event Report SOP (UoB-AES-SOP-001) (Word - 212 KB).
• Risk assessment and implementing processes to mitigate risks. See UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB).
• Project quality management: set up processes (e.g., central & on-site monitoring). See also UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB).
• Archiving plan: consider what research material is to be archived, where it is to be archived and the retention. See UoB Archiving SOP (UoB-ARC-SOP-001) (Word - 198 KB) and Archiving Plan (UoB-ARC-QCD-001) (Word - 104 KB) for a template.

For protocol development and protocol templates, please see the e-Pathway section on ‘Draft your protocol to explore project feasibility’.

For CTIMPs and projects involving complex procedures, a project-specific risk assessment must be performed and documented either within the protocol or within a separate risk assessment document for all clinical research. 

For low-risk projects a statement may be included within the protocol to include an explanation that the project was assessed as being low risk or of comparable risk to standard of care.

Where the risk assessment is a separate document, this should be referenced in the protocol. RGT may request a copy of the risk assessment at sponsor review. 

The risk-assessment will need to be reviewed during the lifetime of the project in particular where there are any substantial amendments made to the project or regulatory changes that could impact the project. 

Please seethe UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB) for further details on carrying out a risk assessment. A Risk Assessment Template (UoB-CLN-TQM-QCD-001) is also available*. 

* This document is currently under review and the link this document has temporarily been removed. If you wish to access it, please contact the Clinical Research Compliance Team at crct@contact.bham.ac.uk.

The participant information sheet (PIS) and informed consent form (ICF) both need to be developed as essential project documents. The project team should engage with the public early in the project set-up and involve them in the design and review of the PIS and ICF.  

• See the UoB Essential Documents Development and Maintenance SOP (UoB-ESD-SOP-001) (Word - 401 KB)
• See the UoB Participant Engagement & Informed Consent SOP (UoB-PEI-SOP-001)  (Word - 130 KB) for specific guidance regarding PIS and ICF development. 

The researcher should consider the following: 

• The need for translation of documents if multiple languages are required
• Separate document versions for different project arms
• Appropriateness of documents for participants and ease of understanding, e.g. age or mental capacity. Pictures may assist participants understanding.
• Whether human tissue is being collected and whether any genomic analysis will be performed
• Are any optional elements clear 

 Where personal data is collected the project team should set-up processes for data collection, handling, storage and destruction in line with the Data Protection Act.  

See the University of Birmingham Data Protection Toolkit (PDF - 1.17 MB).

• The PIS and ICF should state what participant identifiable data will be collected, where it will be stored and what will happen with the data at the end of the project. 

A data capture tool is required to capture the critical data items and any other predefined data items during or after the protocol development. This may be in paper or electronic format. 

• See the UoB Case Report Form Development SOP (UoB-CRT-CRF-SOP-001) (Word - 123 KB)
• See the UoB Essential Documents Development and Maintenance SOP (UoB-ESD-SOP-001) (Word - 401 KB)
• See the UoB Data Management SOP (UoB-DMA-SOP-001) (Word - 315 KB)

REDCap

REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data (including 21 CFR Part 11, FISMA, and HIPAA-compliant environments), it is specifically geared to support online or offline data capture for research studies and operations.

The Research FIRST Service can be approached for support on non-CTIMPs and other projects. They offer a arrange of services including support with the development of REDCap databases. 

Also, via the Research FIRST Service webpage you will find details of a BHP REDCap community that provides a forum for interaction and dialogue about REDCap-related topics. If you wish to register with the community, or would like further information, please email redcapenquiries@contacts.bham.ac.uk.

The statistical analysis plan (SAP) is the pre-specified statistical methodology documented for the project. This can be documented in the protocol or in a separate document.

See UoB Statistics SOP (UoB-CRT-STA-SOP-001) (Word - 137 KB) for more information.

For CTIMPs the completion of an archiving plan is mandatory, for all other research it is considered best practice to have an archive plan in place. An archive plan should be developed as early as possible at the start of the project, in some cases this may need to be in place at the funding stage where additional funding is required for off-site archiving. See the Archiving Plan (UoB-ARC-QCD-001) (Word – 104 KB) for a template. 

The following will need to be considered:

• What data needs to be archived at what time points
• Costs involved if archiving off-site
• What is the format of the data to be archived (i.e. paper or electronic)
• How it will be accessed during the retention period and for what purpose (e.g. inspection, audit)
• Key points of contact for the duration of the archive period (CI, sponsor Archivist etc.)
• The `due date of destruction’ will also need to be considered – this may not always be the date the archived data is destroyed rather a date to review whether to extend the duration of the archive. 

Guidance on retention periods for data is available within Guide to Retention Times (UoB-ARC-QCD-003) (Word – 104 KB). This covers retention timeframes for data related to non-CTIMPs and studies, as well as CTIMPs. 

For further information on archiving, please see the University’s Research Data Management Policy and UoB Archiving SOP (UoB-ARC-SOP-001) (Word – 198 KB).

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 (current page)
• Human Tissue & Data

Green Light - Ready to Go?

Project Management

• 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.